Proposal for a Council Decision on the conclusion of an Agreement on mutual recognition in relation to conformity assessments, between the European Community and the United States of America
Date: 1998-03-30
Institutions: European Commission
Subjects: United States, market access, mutual recognition principle, quality label, trade agreement (EU)

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 30.03.1998 
COM(1998) 180  final 

98/0105 (ACQ 

Proposal for a 

COUNCIL DECISION 

on the conclusion of an Agreement on Mutual Recognition in relation to 
Conformity Assessments, between 
the European Community and the United States of America 

(presented by the Commission) 

EXPLANATORY MEMORANDUM 

I. The Agreement 

On the basis of the negotiating directives issued by the Council on 21.9.92. the European 
Commission  has  negotiated  and  initialled  an  Agreement  on  the  mutual  recognition  of 
conformity  assessment (Mutual Recognition Agreement, or MRA) with the US. A Text 
of the Agreement initialled in June 1997 is annexed. 

This  memorandum  provides  an  assessment  of  the  Agreement  in  the  light  of  the 
negotiating directives approved by the Council, and recommends that the Council decides 
to approve the Agreement by means of a Council decision to that effect. 

LI Assessment of the Agreement 

The  Commission  considers  that  the  initialled  Agreement, is  in  conformity  with  the 
Council's negotiating directives, takes account of the views expressed  by the  113 MRA 
Committee, which  gave detailed advice to the Commission during the negotiations, and 
provides benefits to the European Community. The Agreement does not contain a rule of 
origin. As for Canada this proved to be non-negotiable with the United States. 

Member  States  are in  the process  of  designating  a considerable  number  of  conformity 
assessment  bodies  (CABs). Once these bodies  have been provisionally  accepted  by the 
United  States,  subject  to  formal  acceptance  by  decision  of  the  Joint  Committee,  the 
Council Secretariat will receive this list of CABs by way of a Commission Staff paper. 

Sufficient  confidence  exists  between  the  Parties  to  the  Agreement  to  allow  them  to 
proceed. 

1.1.1 Framework Agreement 

The Agreement consists of a framework  agreement and a series of sectoral annexes. An 
article-by-article assessment of the framework  follows: 

Pre-amble : this sets out the basic objectives of mutual recognition agreements in terms 
of trade facilitation. 

Article 1: Definitions: these are self-explanatory. 

no 

_ 

Article  2: Purpose:  this  article lays  down  the  objective  of  the Agreement,  i.e.  effective 
market  access  through  the  recognition  of  results  of  conformity  assessments.  It  provides 
the basis for terminating the Agreement, should market access be denied. 

Article  3:  General  Obligations:  this  article  sets  out  the  obligation  of  each  Party  to 
accept  the  results  of  conformity  assessments  carried  out  to its  requirements  by  the  other 
Party,  according  to the  terms  of  the  sectoral  annexes.  Notably,  the  provision  establishes 
acceptance  of  product  certifications  and  authorisations  of  each  Party.  This  Article  also 
establishes  the  link  between  the  basic  obligations  of  the  Agreement  and. its  sectoral 
annexes. 

Article  4:  General  Coverage:  this  article  provides  that  the  conformity  assessment 
procedures  to  which  the  Agreement  applies  are  specified  in  the  individual  sectoral 
annexes, and describes the content of the annexes. 

transitional 
Article  5:  Transitional  Arrangements: 
arrangements  set  out  in  the  annex,  to  the  necessity  of  a time  period  for  completion  and 
the possibility  of amending it, and the need  to move to full  implementation  by the end  of 
the  period  unless  there  is  documentary  evidence  that  the  conditions  for  a  successful 
transition are not met. 

this  Article  refers 

the 

to 

Article  6:  Designating  Authorities:  this  is  a  key  provision  requiring  designating 
authorities  to  have  the  necessary  formal  powers  over  the  bodies  they  designate.  This 
article thus provides a guarantee that US has the necessary authority to designate, suspend 
or withdraw bodies. 

Article  7:  Designating  and  Listing  Procedures:  this  article  refers  to  the  procedures 
which  apply  for  the  designation  of  conformity  assessment  bodies,  the  way  additional 
bodies  should  be  proposed,  the  time  period  for  accepting  or  rejecting  new  designations 
and the role of the Joint Committee in this respect. 

Article 8: Suspension of Listed Conformity Assessment Bodies: this article establishes 
the  right  for  one  Party  to  challenge  the  compliance  of  bodies  in  the  other  Party. 
Verification  will  be  carried  out  by  the  Party  in  whose  territory  the CAB  is  located.  The 
CAB  will  be  suspended  where  disagreement  over  its  status  has  been  confirmed  by  the 
Joint  Committee,  unless  otherwise  decided  by  that  Committee.  As  advised  by  the 
Member  States  in  the  113  Committee  MRA  Group,  the  right  of  verification  has  been 
closely circumscribed  to prevent it being carried  out routinely or unilaterally. 

Article  9:  Withdrawal  of  Listed  Conformity  Assessment  Bodies:  this  article 
establishes  a detailed  procedure  and  timing  for  the withdrawal  of conformity  assessment 
bodies,  including  on  the  continued  acceptance  of  the  results  of  conformity  assessments 
carried  out before  their withdrawal. 

Article  10:  Monitoring  of  Conformity  Assessment  Bodies:  this  article  contains  a 
commitment,  from  designating  authorities,  to  ensure  the  continued  capability  of 
conformity  assessment bodies to assess products  or processes. 

Article  11: Conformity  Assessment  Bodies  (CABs): this article states  that CABs  listed 
in  the  Agreement  are  deemed  fulfilling  their  conditions  of  eligibility  for  the  listed 
assessment procedures. 

03 

Article 12: Exchange of Information: a basic transparency  provision. 

Article 13: Sectoral  Contact Point: this provides for the designation  of contact points to 
be responsible for activities under each sectoral annex. 

Article  14:  Joint  Committee:  this  article  requires  the  establishment  of  a  Joint 
Committee  to  administer  the  Agreement  on  behalf  of  the  Parties.  Duties  of  the  Joint 
Committee  include designation  of Joint  Sectoral  Committees  and  the adoption  of  voting 
systems. It includes  the procedure  for formally  adopting  changes  to the Sectoral  annexes 
to add or remove conformity  assessment bodies, and discussing divergence of view. New 
conformity  assessment  procedures  applying  to  covered  products  will  be  brought  within 
the  scope  of  the  Agreement  so  as  to  preserve  negotiated  market  access  benefits.  This 
article  does  not  give  the Joint  Committee  the  right  to  extend  the scope  and  coverage  of 
the agreement to include new sectors. This has to be mandated by the Parties. 

Article  15:  Preservation  of  Regulatory  Authority:  this  article  confirms  that  the 
Agreement has no effect  on each party determining its own level of protection for  human, 
animal  and  plant life  or health.  It provides  for  a safeguard  clause  allowing  each  Party  to 
take urgent measures providing they inform  their counterpart  authority within fifteen  days 
and give the reason for. 

Article  16: Suspension  of recognition  obligations:  is  a key  provision  authorising  each 
Party  to  suspend  its  obligations  in  case  of  loss  of  market  access  or failure,  by the  other 
Party, to maintain authorities capable of implementing  the provisions of the Agreement. 

Article 17: Confidentiality:  this  article, debated  at length, leaves to the legislation of the 
importing  .Party  to  determine  the  extent  of  confidentiality  of  information  transmitted. 
Trade  secrets, confidential  commercial  or financial  information  and  information  relating 
to  ongoing  investigation  may  not  be  disclosed  to  the  public.  It  leaves  to  the  exporting 
party  the  right  to  designate  the  portions  of  information  that  should  be  exempt  from 
disclosure. 

Article  18:  Fees:  this  provides  that  a  Party  shall  not  charge  fees  for  conformity 
assessments  carried  out by  other  Parties  in  accordance  with  the Agreement  and  that  any 
fees charged  will be commensurate with the services  provided. 

Article  19:  Agreements  with  other  countries:  this  article  provides  that  any  Mutual 
Recognition  Agreement between  a Party to this Agreement and other countries  shall have 
no force  in regard  to the other Party to this  Agreement. 

Article  20:  Territorial  application:  this  article  confirms  that  the  Agreement  applies 
only to the territories of the European Community  and the US. 

Article  21: Entry into force,  amendment  and  termination:  this  article lists  all  sectors 
covered  in  the current Agreement  and  states  that  the  Agreement  will enter  into  force  on 
the  first  day  of  the  second  month  following  the  exchange  of  letters  confirming  the 
signature  of  the Agreement,  that  additional  annexes, if  any, will enter into force  30 days 
after  the  relevant  exchange  of  letters,  and  that  the  Agreement  may  be  terminated  by 
giving  the  other  party  six  month  notice.  With  Article  16,  this  article  contains  a  key 

04 

_ 

provision  on  termination  of  the  entire  Agreement  in  case  there  is  no  agreement  on  the 
termination of a certain annex. 

Articles  22:  Final  provisions:  these  are  standard  institutional  and  legal  provisions.  It 
should be noted that the Agreement is of unlimited  duration. 

1.1.2 The Sectoral  Annexes 

There  follows  an  assessment  of  the  content  of  each  sectoral  annex  in  terms  of  its 
coverage,  the type of  mutual  recognition  arrangements  envisaged  for  the  sector,  and  the 
trade  and  other  implications.  In  making  this  assessment,  the  Commission  has  kept  in 
mind the following  elements: 

a)  whether the sectoral annex provides for  genuine mutual recognition, i.e. whether all 
relevant  conformity  assessment  procedures  for  a  particular  sector  have  been 
captured; 

b) 

c) 

d) 

e) 

the  level  of  trade  between  the  Community  and  US  for  the  sectors  and  products 
covered; 

the  views  expressed  by  Member  States  and  European  industry  groups  on  the 
benefits  of mutual recognition; 

the  precedential  nature  (if  any)  of  arriving  at a mutual  recognition  agreement  with 
US in the sectors covered; 

overall  consistency  with  Community  policy  objectives 
field  of 
standardisation,  certification,  designation  of  Conformity  Assessment  Bodies  and 
the removal of technical  barriers to trade. 

the 

in 

The  sectoral  assessment  is  followed  by  an  overall  appreciation  of  the  benefits  of  the 
Agreement. 

The  Commission  draws  Member  States'  attention  to  the  trade  figures  for  each  covered 
sector in the Annex to this note. These figures  show that for every sector concerned,  with 
the  exception  of  medicinal  products,  the  US  have  a  small  trade  surplus  with  the 
Community.  Third  party  certification  (the  subject  of  the  MRA)  applies  most  commonly 
to  industrial  products  at  the  higher  end  of  technology,  in  respect  of  which  both  the 
Community  and  US  are  major  exporters.  A  priori,  this  may  indicate  that  the  trade 
facilitation  benefits  of the Mutual  Recognition  should  accrue to both the Community  and 
the  US.  We  note  however,  that  trade  flows  only  give  a  partial  picture  of  the  likely 
benefits.  The  balance  of  benefits  depends  on  additional  factors,  in  particular  the 
following: 

a) 

trade  facilitation  benefits 

the range of products  within  a sector subject  to third party certification.  Obviously, 
if  in  a  given  sector  one  Party  has  more  comprehensive  certification  requirements, 
the 
i.e.  exporting  Party  may  be 
proportionately  greater.  In this  respect,  the  tendency  for  deregulation  seems  to  be 
more important  in the  EU  and  manufacturers'  declarations  of  conformity  are  more 
used in the EU (e.g. for electrical safety, recreational  crafts); 

the  other 

to 

05 

b) 

the complexity  and accessibility of the conformity  assessment requirements  of each 
Party,  including  the  extent  to  which  each  Party  applies  internationally  recognised 
standards or technical requirements for the sector in question.  This may be an issue 
in various sectors in the case of US which have a fair number of non internationally 
harmonised standards and requirements. 

The Commission  notes that industrial  groups consulted  throughout the negotiations  (such 
as  EUROBIT,  ORGALIME,  EFPIA),  while  supporting  the  agreements,  have  not  been 
able  to  quantify  the  costs  or  time  taken  by  conformity  assessment  of  an  entire  class  of 
products  at  import  in  the  US  or  in  the  EU.  It  is  therefore  not  feasible  in  every  case  to 
determine  the extent  of savings  in  time, cost  or market  opportunity  of the  arrangements 
set  out  in  this  Agreement.  This  may  only  be  possible  once  the  Agreement  has  been  in 
operation for some time. What can be ascertained  however is whether we have addressed 
industry's  concern  that  this  Agreement  provides  reciprocal  levels  of  market  access,  in 
terms of conformity  assessment procedures. 

The  Agreement  also  presents  important  advantages  from  the  point  of  transparency, 
market  access,  avoidance  of  duplication  especially  of  cost,  and  general  facilitation  of 
trade. This is of particular importance for small and medium sized companies. 

On  the  basis  of  a  rough calculation  it  is  estimated  that  this  Agreement  will  create  cost 
savings  for  the  exporting  industry  of  at  least  190  MECU  and  an  equivalent  amount  in 
terms  of  cost  savings  to  exporters  to  the  EU,  some  part  of  which  will  be  passed  on  to 
European importers or consumers. 

Where  relevant,  the  above  factors  are  taken  into  account  in  the  assessment  of  each 
sectoral annex. 

Telecommunication  Equipment 

relevant  Community  Directives, 

This  annex  concerns  all  telecommunications  terminal  equipment  (TTE)  regulated  under 
the 
as  non-harmonised  Member 
States'legislation  for  analogue  connection  to  public  networks  and  radiotransmitters  for 
civilian  applications,  and  the  corresponding  US  legislation.  Both  sectoral  annexes  on 
electrical  safety  and electromagnetic  compatibility  apply  also  to the products  covered  by 
this annex. 

as  well 

Through  the Agreement,  the regulatory authorities  of the parties recognise the  conformity 
assessment  certificates  and  test  reports  issued  by  the  Conformity  Assessment  Bodies  to 
be  listed  in  Section  V.  The  Conformity  Assessment  Bodies  will  be  required  to  comply 
with  the  criteria  and  standards  set  out  in  the  regulatory  requirements  of  the  other  Party 
(set out in  Section  VI). A list  of  Designating  Authorities  is  given in  Section  IV.  A Joint 
Sectoral  Committee  is set up to discuss  technical, conformity  assessment and  technology 
issues relating to this annex and the one on electromagnetic  compatibility. 

The  annex  provides  for  a  transitional  period  of  24  months  to  build  confidence  in  and 
understanding  of each  other's system for  designating  and listing  CABs and  in the  ability 
of  these  bodies  to  test  and  certify  products.  It  provides  for  the  reciprocal  recognition  of 
test  reports  issued  by  designated  CABs  during  the  transitional  period  under  certain 
conditions.  This  transitional  period  will  also  be  used  to  consider  legislative  changes 
needed  and  initiate them  to support  the objectives  of the agreement. There is a provision 
for  the  organisation  of  two  seminars,  during  the  first  year  of  operation  of  the  transition 
« 

06 

arrangements,  on  technical  and  product  approval  requirements.  At  the  end  of  the 
transitional  period  the  Parties  will  grant  full  mutual  recognition  of  compliance 
certificates. 

European 
the  MRA 
industry  organisations  have  been  consulted  extensively  on 
negotiations  and  have  supported  the  approach,  namely  the  logic  built  in  between  this 
annex  and  the  annex  on  electrical  safety,  i.e.  that  this  annex  would  only  operate  once 
enough  CABs  have  been  accepted  for  recognition.  This  provision  ensures  indeed  a 
balanced  access  to  both  markets. The  agreement  does  provide for  reciprocal  recognition 
of  all  conformity  assessment  procedures  including  final  certification  without  further 
product assessment by the importing party. 

Electrical  Safety 

This  annex  covers  the  testing  and  certification  requirements  set  out  in  the  EC's  Low 
Voltage  Directive  and  corresponding  US  regulations,  including  medical  devices, 
telecommunication  equipment  and  their  electromagnetic  compatibility  aspects,  and 
except products certified  or approved under the Federal Mine Safety  and Health Act. 

A  Joint  Sectoral  Committee  is  set  up  by  section  VII,  with  OSHA  representing  the  US. 
Sections IV and V of the annex list the authorities  responsible for  designating  the  CABs 
and the CABs themselves  (an initial list of CABs  has to be included  when the  agreement 
is implemented).  Section VI describes  the procedures for designating  and suspending  the 
CABs.  OSHA  (Occupational  and  Safety  Health  Administration)  will validate  within  30 
days  application  dossiers  and  confirm  CABs  in  Section  V within  120 days.  OSHA  will 
rely  on  the  EC  designating  Authorities  for  conducting  on-site  reviews  at  the  respective 
Member  States'  CABs.  This  is  a  major  improvement  vis-à-vis  the  current  situation. 
OSHA  also  agreed  to consider  regulatory  and  legislative  changes  needed  to  support  the 
objective of an MRA. 

European industry  groups have been consulted  on the proposed MRA and have expressed 
support  provided  that  we  ensure  that  any  agreement  provides  for  reciprocity  of  market 
access  and  does  not  lead  to  the  introduction  of  new  and  more  onerous  requirements. 
Given  the  existing  openness  of  the  EC  regime,  and  the  fact  that  the  necessary  US 
legislation is covered  under the sectoral annex, these requirements  have clearly been  met. 
While  manufacturers'  self  certification  exists  in  the  EC,  third  party  certification  is 
required  for  certain  categories  of  products  in  the  US  and  there  are  therefore  clear 
advantages in the Agreement from  an EC perspective. 

Electromagnetic Compatibility  (EMC) 

In view of the "horizontal" application  of EMC requirements to a wide range of electrical, 
machinery  and  telecommunications  products,  coverage  of  the  EMC  phenomenon  in  the 
MRA is necessary to achieve the objective  of covering all relevant conformity  assessment 
procedures. 

Each  Party  agrees  to  recognise  the  other  Party's  results  of  the  conformity  assessment 
procedures  carried  out  by the  CABs  listed  in  section  V  of  the  annex,  as  required  under 
their respective legislation, without any further  assessment of the products. 

The  Agreement  also  provides  for  a  transitional  arrangement  of  24  months.  During  this 
period  the  Parties  will  work  together  to  ensure  familiarity  with  each  other's  regulatory 
• 

07 

requirements,  exchange  information  and  review  the  work  carried  out  by  designated 
Conformity  Assessment  Bodies  and  demonstrate  to  each  other's  satisfaction  their 
capability  to  carry  out  conformity  assessment  to  the  requirements  of  the  other  Party. 
During the first year of operation of the agreement,, the parties may jointly sponsor two 
seminars on the relevant technical and product approval requirements. 

Recreational Craft 

The  sectoral  annex  for  recreational  craft  applies  to  all  recreational  craft,  including 
personal  watercraft,  which  are  subject  to  third  party  certification  in  the  European 
Community  or US. The Agreement covers all relevant legislation  (Directive 94/25) and 
the  Federal  regulations  in  US.  Both  sectoral  annexes  on  electrical  safety  and 
electromagnetic compatibility apply also to the products covered by this annex. 

The  Parties  will  recognise  certificates  issued  by  each  other's  designated  Conformity 
Assessment Bodies without  any further  assessment of the products to which they relate. 
A  list  of  Designating  Authorities  is  given  in  Section  3.  The  Conformity  Assessment 
Bodies will be required to comply with the criteria and standards set out in the regulatory 
requirements of the other Party (set out in Section 4). The Conformity Assessment Bodies 
are to be listed in Section 5. 

The annex provides for a transitional arrangement of 18 months in which the Parties will 
cooperate to establish a system for designating CABs and build confidence  in the ability 
of these bodies.  During this period, they will exchange information on technical data and 
conformity  assessment  procedures,  developing  greater  familiarity  with  their  respective 
regulatory  requirements,  and  carry  out the legislative  and  regulatory  changes necessary 
for  the  provisions  of  their  annex.  During  this  period,  the  parties  shall  endeavour  to 
sponsor  seminars  for  the  purpose  of  improving  the  understanding  of  the  respective 
technical requirements. 

Pharmaceuticals Good Manufacturing Practice (GMP) 

This annex establishes  mutual  recognition  of each Party's inspections of pharmaceutical 
sites  according  to  the  GMP  standards  of  each,  which,  subject  to  further  verification 
during the transition  phase, have been declared  '"equivalent" by the Steering Committee 
of the International Conference on Harmonisation. 

Recognition  of  inspection  results  is  not  automatic.  Inspection  reports  will  have  to  be 
transmitted  and  "normally  endorsed"  by  the importing  party  except  under specific  and 
delineated circumstances.  Endorsement of each other's inspection reports should remove 
the need for companies in each Party to be inspected by the authorities of the other Party. 
The products  traded  need  no  further  batch.testing  and  control  upon  import, except  for 
biologicals,  when  an  official  batch  release  procedure  applies  (also  called  lot-by-lot 
testing);  in this case, controls are carried out by the authorities. 

The scope  of  the annex covers  all medicinal  products  regulated  by both parties, except 
veterinary  biologicals,  which  are  regulated  by  a  different  US  Agency  (APHIS).  A 
separate annex to the agreement is being negotiated  for  these products.  Human plasma 
derivatives,  investigational  medicinal  products,  radiopharmaceuticals  and  medicinal 
gases  are  not  included  in  the  transitional  arrangements  and  their  situation  will  be 

08 

reconsidered  at the end of the transition phase.  An indicative list of such products is also 
included  (appendix 3 of sectoral annex). 

This  annex  applies  only to pharmaceutical  products  subject  to GMP in either Party. This 
permits inspections to be carried  out against each Party's domestic GMP standard in most 
cases. 

The  annex  lists  the  applicable  legislation  and  relevant  certifying  authorities.  It  also  sets 
out in  appendices  4 and 5 to the sectoral  annex, the criteria for  assessing  equivalence  of 
post-  and  pre-approval  inspections  and  the  elements  to  be  considered  in  developing  an 
alert system. It sets up a Joint Sectoral Committee. 

A three-year  transition  period  is  aimed  at determining  the equivalence  of the  "regulatory 
systems".  All  authorities  are  requested  to  actively  participate  in  the  determination  of 
equivalence exercises in order to build  a sufficient  body of evidence for their equivalence 
determination. 

At  the  beginning  of  the  transition  period,  the  parties  will  exchange  their  draft 
programmes.  Their implementation will permit the determination  of the capacity  of each 
Party's  authority  to  perform  GMP  inspections  and  ensure  the  appropriate  enforcement. 
At  the  end  of  this  period,  a  list  of  authorities  deemed  equivalent  will  be  agreed  by  the 
Joint  Sectoral  Committee  and  any  insufficient  evidence  of  equivalence,  lack  of 
opportunity  to  assess equivalence  or  determination  of  non-equivalence  will  have  to  be 
documented in sufficient  detail. 

European  industry  and  Member  States'  inspection  authorities  (Working  Group  on 
Inspection  and  control  of  medicinal  products,  and  the  Pharmaceutical  Committee)  have 
been consulted  at every step of the negotiation  and support the arrangements  negotiated. 

This agreement provides mutual benefits  to pharmaceutical  companies, and some savings 
to inspection  authorities.  The present agreement also establishes mechanisms  for  longer-
term cooperation between respective inspection  authorities  which will not only ensure the 
agreement  continues  to  be  properly  applied,  but  will  stimulate  further  harmonisation 
initiatives.  The  Community  and  the  US  are  important  trade  partners  in  this  sector  and 
trade is well balanced  (see Annex 4) as well as the benefits  expected from  the Agreement. 

Medical  Devices 

This  annex  establishes  mutual  recognition  of  the  results  of  quality-system-related 
evaluations  and inspections  and pre-market evaluations  as conducted  by listed  conformity 
assessment  bodies  (CABs); it  provides  also  for  other  related  co-operative  activities  such 
as  an  exchange  of  post-market  vigilance  reports  with  regards  to  all  products  regulated 
under both US and EC legislation. 

This  recognition  is not  automatic.  Various  types  of  reports  will  have  to  be  transmitted; 
they  will  be  "normally  endorsed"  by  the  importing  party,  except  under  specific  and 
delineated  circumstances.  Endorsement  of  each  other's  reports  should  remove  the  need 
for  companies  in each  Party  to  be inspected  and  their  application  files  be re-assessed  by 
the authorities of the other Party. 

09 

Product coverage, within the two Community  Directives  for  medical devices, and for  US 
their domestic legislation in this field, is determined in the annexes of the agreement and 
varies  according  to  the  nature  of  the  evaluation  and  the  phase  of  the  agreement.  For 
quality  systems  evaluations,  the  agreement  covers  all  products  regulated  under  both  EU 
and US legislation.  For products evaluations  (product  approvals), the scope is limited  to 
those products classified  under the US system as Class I/Class II - Tier 2 which are listed 
in  Appendix  2  of  the sectoral  annex.  The  annex  thus  covers  all  conformity  assessment 
procedures in the Parties, including final  certification  and approval for the products listed 
in the agreement. 

The  annex  provides  for  a transition  period  (3 years)  which  will  evaluate  the  capabilities 
of the proposed  Conformity  Assessment  Bodies. Conformity  Assessment  Bodies  willing 
to participate  in  the confidence-building  activities  and  meeting  the criteria  for  technical 
competence and independence will be designated  by each party  and listed in Appendix 4. 
At the end of the transition period, the CABs will be jointly confirmed  in an Appendix 5. 
Any  "non-confirmation"  of  a  proposed  CAB  would  have  to  be  justified  based  on 
documented evidence. 

A Joint  Sectoral  Committee is set up and  at the beginning  of the transition period, it will 
establish  a joint  confidence  building  programme  including  seminars,  workshops,  joint 
training  exercises,  observed  inspections  and  the  design  of  an  appropriate  system  of 
exchange  of information.  The Parties  will, during  the transition,  work to  harmonise  the 
necessary  information  which  must  be  present  in  quality  systems, and  product  evaluation 
reports; 
they  will  also  develop  a  notification  and  alert  system.  An  annual  report  will 
describe  the  progress  of  the exercise. Harmonisation  activities  will  include  participation 
in the Global Harmonisation Task Force and the utilisation of its results. 

The  requirements  of  third  party  premarket  assessment  are  extensive  on  both  sides  and 
cover  up  to  90%  of  the  field.  In  this  respect  therefore  we  consider  that  the  agreement 
presents a balance of advantages to both parties. 

In  the  light  of  the  above,  we  believe  European  industry  is  content  with  the  proposed 
MRA in  this  sector.  It is worth  mentioning  that  the US  Senate Committee  on Labor  and 
Human  resources  recently  stated  that  the  MRA  "will  lay  a  flagstone  in  the  path  being 
built  toward  harmonization  activities  on  things  like  increase  reliance  on  international 
standards".  The  Commission  considers  that  the  MRA  in  this  sector  sets  the  right 
precedents  in  terms  of  our long  term  objectives.  All certification  procedures  are  covered 
and the product coverage will extend with time. 

1.1.3 Relations with EFTA States, members of the European Economic Area 

In accordance  with  the  general  information  and  consultation  procedures  set  out  in  the 
EEA Agreement  and Protocol  12 of the said Agreement,  the Commission  has kept EFTA 
/ EEA States regularly informed  about developments in the negotiations and has  informed 
them on the final  result of the negotiations. 

The EFTA / EEA States have had preliminary  talks with  the US for  negotiating  a mutual 
recognition agreement equivalent to the one to be concluded  between the Community  and 
the US. 

10 

1.1.4 Overall Appreciation 

The  Commission  considers  that  the  proposed  MRAs  create  an  acceptable  balance  of 
benefits  for  all  parties  overall,  when  all  sectors  are  taken  together.  The  overall  trade 
balance  with  the US  and  the  nature  of  the  current  certification  procedures  in  the  US 
would  also  suggest  that  the  Agreement  will  bring  a number  of  improvements  for  EC 
exporters. In all sectors the Community has secured effective  market access - in terms of 
access to all mandatory procedures of the other party. US has accepted the Community's 
approach of reciprocally recognising not only testing, but also certificates  and approvals 
of  conformity  to  the  other's  requirements.  The  agreement  will  allow  Community 
exporters, if they so choose, to test and certify  their products to US requirements prior to 
export,  and  then  access  those  markets  without  any  further  conformity  assessment 
requirements.  This  will  facilitate  Community  exports.  European  industry  federations 
have been consulted on the Agreement and have supported it. 

The  Commission  has  received  indications  that  a  large  number  of  EC  conformity 
assessment bodies would be interested to work in the framework  of this Agreement, and 
this indicates both their technical capacity and economic interest in the Agreement. 

In  several  sectors  the  Agreement  caters  for  the  further  development  of  the  parties' 
regulatory  regimes,  with  the  aim  of  ensuring  that  future  rules  do  not  undermine  the 
benefits  of  the  agreement.  And in  several  sectors, the agreement  will  help to  promote 
wider acceptance of the Community's regulatory approach and technical requirements. 

II. Proposal for a Council Decision 

A proposal for  a Council decision on the conclusion  of the Agreement is attached. The 
decision has two objectives: 

a) to approve, on the basis of Articles  113 and 228 of the Treaty, the draft  Agreement; 
and 

b) to establish the appropriate Community procedure to enable the Commission, assisted 
by  the  113  Committee  (Technical  Group  on  Mutual  Recognition),  to  represent  the 
Community in the Joint Committee and the Joint Sectoral Committees established by the 
Sectoral Annexes  and  that the Community position in  that Joint  Committee  and  in the 
Joint Sectoral Committees in case of changes to the Annexes and other sectoral questions 
be  determined  in  conformity  with  Article  228,  paragraph  4  of  the  Treaty,  by  the 
Commission in consultation with the 113 Committee. 

On this second aspect, it is noted that in Article  14 of the Agreement, a Joint Committee 
of the Parties  operates. This Joint Committee is  responsible for  the management  of the 
Agreement and has the delegated power to amend existing sectoral annexes. Such right of 
amendment  is  restricted  only  to  procedural  issues  concerned  with  implementation, 
essentially:  amending  the  references  to  the  regulations  applicable  to  covered  sectors; 
amending  the  annexes  further  to decisions  to recognise,  suspend,  remove,  or  alter  the 
scope  of  activity  of  conformity  assessment  bodies  or  designating  authorities  in  the 
Agreement. The power to amend the framework  agreement, to delete sectoral annexes or 
to add new sectoral annexes rests with the Parties. 

It is accordingly proposed that: 

11 

« 

a)  the  Commission,  assisted  by  the  113  Committee  (Technical  Group  on  Mutual 
Recognition)  should  represent  the Community  in  the Joint  Committee  and in  the Joint 
Sectoral  Committees  established  by  the  Sectoral  Annexes,  and  that  the  Community 
position in that Joint Committee and in the Joint Sectoral Committees in case of changes 
to  the  annexes  and  other  sectoral  questions  be determined,  in  conformity  with  Article 
228, paragraph 4 of the Treaty, by the Commission following  consultation  of the above 
mentioned committee. 

b) for all other issues, the Community position shall be determined by the Council, acting 
by qualified majority on a proposal from the Commission. 

The Commission therefore proposes that the Council adopts the appended decision, and 
indicates the person who, on behalf of the Community, signs the Agreement. 

I& 

Proposai for a Council Decision 

on the conclusion of an Agreement on Mutual Recognition in relation to 
Conformity Assessments, between 
the European Community and the United States of America 
(.../.../EC) 

The Council of the European Union, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular 
Article  113  in  conjunction  with  Article  228,  paragraph  (2),  (3)  first  paragraph  and  (4) 
thereof, 

Having regard to the proposal of the Commission, 

Whereas  the  Agreement  on  Mutual  Recognition  in  relation  to  Conformity  Assessment, 
between  the  European  Community  and  the  US, initialled  in  Brussels  on  20  June  1997, 
has been negotiated  and should be approved, 

Whereas  certain  tasks  for  implementation  have  been  attributed  to  the  Joint  Committee 
established  by the Agreement, and in particular the power to amend the Sectoral Annexes 
thereto; 

Whereas  the  appropriate  internal  procedures  should  be  established  to  ensure  the  good 
functioning  of  the  Agreement,  and  whereas  it  is  therefore  necessary  to  delegate  to  the 
Commission the power to proceed to certain technical amendments of the Agreement and 
to take certain decisions for its implementation, 

Decides: 

Article 1 

The  Agreement  on  Mutual  Recognition  in  relation  to  Conformity  Assessment  between 
the European  Community  and  US, including  its  Annexes  are hereby  approved  on  behalf 
of the European Community. 

The text of the Agreement and the Annexes are attached to this Decision. 

Article 2 

The  President  of  the  Council  shall,  on  behalf  of  the  Community,  transmit  the  letter 
provided for in Article 21 of the Agreement1 

1  The  date  of  the entry  into  force  of  the Agreement  will be published  in  the  Official  Journal  of  the 

European Communities. 

d3 

# 

Article 3 

1.  The Commission  shall represent the Community in the Joint Committee provided 
for  in  Article  14  of  the  Agreement,  and  in  the  Joint  Sectoral  Committees 
established by the Sectoral Annexes, assisted  by the special committee established 
under Article  113 of the EC Treaty  (Mutual Recognition). The Commission  shall 
proceed, after consultation  with this committee, to the appointments, notifications, 
exchange of information  and the requests for verifications  referred  to in Article 10, 
letter b), 12, 13 and 14 paragraph 2 of the Agreement and the equivalent provisions 
of its Sectoral Annexes. 

2. 

3. 

The  position  of  the  Community  in  regard  of  decisions  to  be  taken  by  the  Joint 
Committee or if appropriate in the Joint Sectoral Committees shall be determined, 
with regard to amendments of the Sectoral Annexes (Article  14, paragraph 4, letter 
b),  and Articles  7, 8 and 9 of  the Agreement  and the equivalent provisions  of its 
Sectoral Annexes, and verification  of compliance in accordance with Article 7 d) of 
the Agreement by the Commission, following  consultation of the above mentioned 
special committee. 

In  all  other  cases  the  position  of  the  Community  for  a  decision  in  the  Joint 
Committee or Joint Sectoral Committees shall be determined by the Council, acting 
by  qualified  majority  on  a proposal  from  the  Commission.  The  same  procedure 
shall apply to decisions taken by the EC in the framework  of Articles 16 and 21. 

Done at Brussels, 

For the Council 
The President 

14 

AGREEMENT ON MUTUAL RECOGNITION 

BETWEEN THE UNITED STATES OF AMERICA AND 

THE EUROPEAN COMMUNITY 

Electromagnetic Compatibility (EMC) 

Page 29 

TABLE  OF  CONTENTS 

•» 

1. 

Framework 

Telecommunication Equipment 

2. 

3. 

4. 

5. 

6. 

Electrical Safety 

Recreational Craft 

Pharmaceutical Good Manufacturing 
Practice (GMP) 

7.  Medical Devices 

Page 1 

Page 15 

Page 39 

Page 49 

Page 55 

Page 71-113 

15 

Initialled on 20 June  1997 

AGREEMENT ON MUTUAL RECOGNITION 

BETWEEN THE UNITED STATES OF AMERICA AND 

THE EUROPEAN COMMUNITY 

The Government of the United States of America and the European Community, 
hereinafter referred to as "the Parties ", 

Considering the traditional links of friendship  that exist between the United States 
of America (U.S.) and the European Community (EC); 

Desiring to facilitate bilateral trade between them; 

Recognizing  that  mutual  recognition  of  conformity  assessment  activities  is  an 
important means of enhancing market access between the Parties; 

Recognizing  that  an  agreement  providing  for  mutual  recognition  of  conformity 
assessment activities is of particular interest to small and medium-sized businesses 
in the U.S. and the EC; 

Recognizing  that  any  such  mutual  recognition  also  requires  confidence  in  the 
continued reliability of the other Party's conformity assessments; 

Recognizing  the  importance  of  maintaining  each  Party's  high  levels  of  health, 
safety, environmental and consumer protection; 

Recognizing  that  mutual  recognition  agreements  can  positively  contribute  in 
encouraging greater international harmonization of standards; 

Noting that this Agreement is not intended to displace private sector bilateral and 
multilateral  arrangements  among  conformity  assessment  bodies  or  to  affect 
regulatory  regimes allowing  for  manufacturers'  self-assessments  and  declarations 
of conformity. 

I 

l fi 
u 

x 

Initialled on 20 June  1997 

Bearing in mind that the Agreement on Technical Barriers to Trade, an agreement 
annexed  to  the  Agreement  establishing  the  World  Trade  Organization  (WTO), 
imposes  obligations  on  the  Parties  as  Contracting  Parties  to  the  WTO,  and 
encourages such Contracting Parties to enter into negotiations for the conclusion of 
agreements  for  the  mutual  recognition  of  results  of  each  other's  conformity 
assessment; 

Recognizing  that  any  such  mutual  recognition  needs  to  offer  an  assurance  of 
conformity  with  applicable  technical  regulations  or  standards  equivalent  to  the 
assurance offered  by the Party's own procedures; 

Recognizing the need to conclude an Agreement on Mutual Recognition (MRA) in 
the field of conformity assessment with sectoral annexes; and 

Bearing in mind the respective commitments of the Parties under bilateral, regional 
and multilateral environment, health, safety and consumer protection agreements. 

Have agreed as follows: 

Article 1 

DEFINITIONS 

1.  The following terms and definitions shall apply to this Agreement only: 

Designating Authority  means a body  with power  to designate,  monitor, 
suspend,  remove  suspension  of,  or  withdraw  conformity  assessment 
bodies as specified under this Agreement. 

Designation  means  the  identification  by  a  Designating  Authority  of  a 
conformity assessment body to perform conformity assessment procedures 
under this Agreement. 

Regulatory Authority means a government agency or entity that exercises 
a  legal  right  to  control  the  use  or  sale  of  products  within  a  Party's 
jurisdiction  and  may  take  enforcement  action  to  ensure  that  products 
marketed within its jurisdiction comply with legal requirements. 

2.  Other terms concerning  conformity  assessment  used  in this  Agreement  shall 
have  the  meaning  given  elsewhere  in  this  Agreement  or  in  the  definitions 
contained  in  Guide  2  (1996  edition)  of  the  International  Organization  for 
Standardization  (ISO)  and  the  International  Electrotechnical  Commission 
(IEC).  In  the  event  of  an  inconsistency  between  ISO/IEC  Guide  2  and 
definitions in this Agreement, the definitions in this Agreement shall prevail. 

17 

Initialled on 20 June  1997 

Article 2 

PURPOSE OF THE AGREEMENT 

This  Agreement  specifies  the  conditions  by  which  each  Party  will  accept  or 
recognize  results  of  conformity  assessment  procedures,  produced  by  the  other 
Party's conformity  assessment bodies or authorities, in assessing conformity  to the 
importing  Party's  requirements,  as  specified  on  a  sector-specific  basis  in  the 
Sectoral  Annexes,  and  to  provide  for  other  related  cooperative  activities.  The 
objective  of  such  mutual  recognition  is  to  provide  effective  market  access 
throughout the territories of the Parties with regard to conformity  assessment for all 
products  covered  under  this  Agreement.  If  any  obstacles  to  such  access  arise, 
consultations  will  promptly  be held.  In the  absence  of  a satisfactory  outcome  of 
such  consultations,  the  Party  alleging  its  market  access  has  been  denied,  may, 
within 90 days of such consultation, invoke its right to terminate the Agreement in 
accordance with Article 21. 

Article 3 

GENERAL OBLIGATIONS 

The  United  States  shall,  as  specified  in  the  Sectoral  Annexes,  accept  or 
recognize  results  of  specified  procedures,  used  in  assessing  conformity  to 
specified  legislative,  regulatory,  and  administrative  provisions  of  the United 
States,  produced  by  the  other  Party's  conformity  assessment  bodies  and/or 
authorities. 

The  European  Community  and  its  Member  States  shall,  as  specified  in  the 
Sectoral Annexes, accept or recognize results of specified  procedures, used in 
assessing  conformity  to  specified  legislative,  regulatory  and  administrative 
provisions  of the  European  Community  and  its  Member  States, produced  by 
the other Party's conformity assessment bodies and/or authorities. 

Where  sectoral  transition  arrangements  have  been  specified  in  Sectoral 
Annexes, the above obligations will apply following the successful  completion 
of  those  sectoral  transition  arrangements,  with  the  understanding  that  the 
conformity  assessment  procedures  utilized  assure  conformity 
the 
satisfaction  of the receiving  Party, with applicable  legislative, regulatory  and 
administrative provisions of that Party, equivalent to the assurance offered  by 
the receiving Party's own procedures. 

to 

Ie 

^ 

Initialled on 20 June  1997 

Article 4 

GENERAL COVERAGE OF THE AGREEMENT 

1.  This  Agreement  applies  to  conformity  assessment  procedures  for  products 
and/or processes and to other related cooperative activities as described  in this 
Agreement. 

2.  Sectoral Annexes may include: 

a)  a  description  of  the  relevant  legislative,  regulatory  and  administrative 
provisions  pertaining  to  the  conformity  assessment  procedures  and 
technical regulations; 

b)  a statement on the product scope and coverage; 

c)  a list of Designating Authorities; 

d)  a list  of  agreed  conformity  assessment  bodies  or authorities  or a source 
from which to obtain a list of such bodies or authorities and a statement of 
the  scope  of  the  conformity  assessment  procedures  for  which  each  has 
been agreed; 

e) 

the  procedures  and  criteria  for  designating  the  conformity  assessment 
bodies; 

f)  a description of the mutual recognition obligations; 

g)  a sectoral transition arrangement; 

h) 

the identity of a sectoral contact point in each Party's territory; and 

i)  a statement regarding the establishment of a Joint Sectoral Committee. 

3.  This Agreement shall not be construed to entail mutual acceptance of standards 
or  technical  regulations  of  the  Parties  and,  unless  otherwise  specified  in  a 
Sectoral  Annex,  shall  not entail  the  mutual  recognition  of  the  equivalence  of 
standards or technical regulations. 

19 

Initialled on 20 June  1997 

Articles 

TRANSITIONAL ARRANGEMENTS 

The  Parties  agree  to  implement  the  transitional  commitments  on  confidence 
building as specified in the Sectoral Annexes. 

1.  The Parties agree that each sectoral transitional arrangement shall specify a 

time period for completion. 

2.  The Parties may amend any transitional arrangement by mutual agreement. 

3.  Passage  from  the transitional  phase to the operational  phase  shall  proceed  as 
specified  in  each  Sectoral  Annex,  unless  either  Party  documents  that  the 
conditions provided in such Sectoral Annex for a successful  transition are not 
met. 

Article 6 

DESIGNATING AUTHORITIES 

The Parties shall ensure that the Designating Authorities  specified  in the  Sectoral 
Annexes have the power and competence in their respective territories to carry out 
decisions under this Agreement to designate, monitor, suspend, remove suspension 
of, or withdraw conformity assessment bodies. 

Article 7 

DESIGNATION AND LISTING PROCEDURES 

The following  procedures shall apply with regard to the designation of  conformity 
assessment  bodies  and  the  inclusion  of  such  bodies  in  the  list  of  conformity 
assessment bodies in a Sectoral Annex: 

a)  The Designating  Authority  identified  in a Sectoral Annex shall  designate 
conformity  assessment  bodies  in  accordance  with  the  procedures  and 
criteria set forth in that Sectoral Annex; 

b)  A Party proposing to add a conformity  assessment body to the list of such 
bodies  in  a  Sectoral  Annex  shall  forward  its  proposal  of  one  or  more 
designated conformity assessment bodies in writing to the other Party with 
a view to a decision by the Joint Committee; 

20 

Initialled on 20 June 1997 

c)  Within  60  days  following  receipt  of  the  proposal,  the  other  Party  shall 
indicate  its  position  regarding  either  its  confirmation  or  its  opposition. 
Upon  confirmation,  the  inclusion  in  the  Sectoral  Annex  of  the  proposed 
conformity assessment body or bodies shall take effect; and 

d)  In  the  event  that  the  other  Party  contests  on  the  basis  of  documented 
evidence  the  technical  competence  or  compliance  of  a  proposed 
conformity  assessment  body,  or  indicates  in  writing  that  it  requires  an 
additional  30  days  to  more  fully  verify  such  evidence,  such  conformity 
assessment body shall not be included on the list of conformity  assessment 
bodies  in  the  applicable  Sectoral  Annex.  In  this  instance,  the  Joint 
Committee  may  decide  that  the  body  concerned  be  verified.  After  the 
completion  of  such  verification,  the  proposal  to  list  the  conformity 
assessment  body  in the  Sectoral  Annex  may  be resubmitted  to  the  other 
Party. 

Article  8 

SUSPENSION OF LISTED CONFORMITY ASSESSMENT  BODIES 

The following procedures shall apply with regard to the suspension of a conformity 
assessment body listed in a Sectoral Annex: 

a)  A  Party  shall  notify  the  other  Party  of  its  contestation  of  the  technical 
competence  or  compliance  of  a  conformity  assessment  body  listed  in  a 
Sectoral  Annex  and  the  contesting  Party's  intent  to  suspend  such 
conformity  assessment  body.  Such  contestation  shall  be  exercised  when 
justified  in an objective and reasoned manner in writing to the other Party; 

b)  The conformity assessment body shall be given prompt notice by the other 
Party  and  an  opportunity  to  present  information  in  order  to  refute  the 
contestation  or  to  correct  the  deficiencies  which  form  the  basis  of  the 
contestation; 

c)  Any  such  contestation  shall  be  discussed  between  the  Parties  in  the 
relevant Joint Sectoral Committee. If there is no Joint Sectoral Committee, 
the contesting Party shall refer the matter directly to the Joint Committee. 
If agreement to suspend is reached  by the Joint  Sectoral  Committee  or,  if 
there  is  no  Joint  Sectoral  Committee,  by  the  Joint  Committee,  the 
conformity assessment body shall be suspended; 

d)  Where  the  Joint  Sectoral  Committee  or  Joint  Committee  decides  that 
verification  of  technical  competence  or  compliance  is  required,  it  shall 
normally be carried out in a timely  manner by the Party in whose territory 
the  body  in  question  is  located,  but  may  be  carried  out  jointly  by  the 
Parties in justified cases; 

21 
^  — 

Initialled on 20 June  1997 

e) 

If the matter has not been resolved by the Joint Sectoral Committee within 
10 days of the notice of contestation,  the matter shall  be referred  to the 
Joint Committee for a decision.  If there is no Joint Sectoral  Committee, 
the matter shall be referred directly to the Joint Committee. If no decision 
is reached by the Joint Committee within  10 days of the referral  to it, the 
conformity  assessment  body  shall  be suspended  upon  the request  of the 
contesting Party; 

f)  Upon the suspension of a conformity  assessment body listed in a Sectoral 
Annex, a Party is no longer obligated to accept or recognize the results of 
conformity  assessment  procedures  performed  by 
that  conformity 
assessment  body  subsequent  to  suspension.  A  Party  shall  continue  to 
accept the results of conformity  assessment procedures performed  by that 
conformity  assessment  body  prior  to  suspension,  unless  a  Regulatory 
Authority  of  the  Party  decides  otherwise  based  on  health,  safety  or 
environmental  considerations  or  failure  to  satisfy  other  requirements 
within the scope of the applicable Sectoral Annex; and 

g)  The suspension shall remain in effect  until agreement has been reached by 

the Parties upon the future status of that body. 

Article 9 

WITHDRAWAL OF LISTED CONFORMITY ASSESSMENT BODIES 

The following procedures shall apply with regard to the withdrawal from a Sectoral 
Annex of a conformity assessment body: 

a)  A Party proposing to withdraw a conformity  assessment body  listed  in a 
Sectoral Annex shall forward its proposal in writing to the other Party; 

b)  Such conformity  assessment body shall be promptly notified  by the other 
Party  and  shall  be provided  a period  of at  least  30 days  from  receipt  to 
provide information  in order to refute  or to correct the deficiencies  which 
form the basis of the proposed withdrawal; 

c)  Within  60  days  following  receipt  of  the  proposal,  the  other  Party  shall 
indicate  its  position  regarding  either  its  confirmation  or  its  opposition. 
Upon confirmation,  the withdrawal from the list in the Sectoral Annex of 
the conformity assessment body shall take effect; 

Z  tj 

Initialled on 20 June  1997 

d) 

e) 

In  the  event  the  other  Party  opposes  the  proposal  to  withdraw  by 
supporting  the  technical  competence  and  compliance  of  the  conformity 
assessment body, the conformity assessment body shall not at that time be 
withdrawn from the list of conformity  assessment bodies in the applicable 
Sectoral Annex. In this instance, the Joint Sectoral Committee or the Joint 
Committee  may  decide  to  carry  out  a  joint  verification  of  the  body 
concerned.  After  the  completion  of  such  verification,  the  proposal  for 
withdrawal of the conformity  assessment body may be resubmitted  to the 
other Party; and 

Subsequent to the withdrawal of a conformity  assessment body listed in a 
Sectoral Annex, a Party shall continue to accept the results of  conformity 
assessment  procedures  performed  by  that  conformity  assessment  body 
prior  to  withdrawal,  unless  a  Regulatory  Authority  of  the  Party  decides 
otherwise  based  on  health,  safety  and  environmental  considerations  or 
failure  to  satisfy  other  requirements  within  the  scope  of  the  applicable 
Sectoral Annex. 

Article 10 

MONITORING OF CONFORMITY ASSESSMENT BODIES 

The following  shall apply with regard to the monitoring of conformity  assessment 
bodies listed in a Sectoral Annex: 

a)  Designating  Authorities  shall  assure  that  their  conformity  assessment 
bodies  listed  in  a  Sectoral  Annex  are  capable  and  remain  capable  of 
properly assessing conformity of products or processes, as applicable, and 
as covered  in the applicable  Sectoral  Annex. In this regard,  Designating 
Authorities shall maintain, or cause to maintain, ongoing surveillance over 
their  conformity  assessment  bodies  by  means  of  regular  audit  or 
assessment; 

b)  The  Parties  undertake  to  compare  methods  used  to  verify  that  the 
conformity  assessment bodies listed in the Sectoral Annexes comply with 
the relevant  requirements  of the  Sectoral  Annexes. Existing  systems  for 
the  evaluation  of  conformity  assessment  bodies  may  be  used  as  part  of 
such comparison procedures; 

c)  Designating Authorities shall consult as necessary with their counterparts, 
to  ensure  the  maintenance  of  confidence  in  conformity  assessment 
procedures.  With  the  consent  of  both  Parties,  this  consultation  may 
include  joint  participation  in  audits/inspections  related  to  conformity 
assessment  activities  or  other  assessments  of  conformity  assessment 
bodies listed in a Sectoral Annex; and 

23 

Initialled on 20 June  1997 

d)  Designating  Authorities  shall  consult,  as  necessary,  with  the  relevant 
Regulatory  Authorities  of  the  other  Party  to  ensure  that  all  technical 
requirements are identified and are satisfactorily addressed. 

Article 11 

CONFORMITY ASSESSMENT  BODIES 

Each Party recognizes that the conformity  assessment  bodies  listed  in the  Sectoral 
Annexes  fulfill  the conditions  of  eligibility  to assess  conformity  in relation  to  its 
requirements  as  specified  in  the  Sectoral  Annexes.  The  Parties  shall  specify  the 
scope of the conformity assessment procedures for which such bodies are listed. 

Article  12 

EXCHANGE OF INFORMATION 

1.  The Parties shall  exchange  information  concerning  the implementation  of the 
legislative, regulatory, and administrative provisions  identified  in the Sectoral 
Annexes. 

2.  Each  Party  shall  notify  the  other  Party  of  legislative,  regulatory  and 
administrative  changes related to the subject matter of this Agreement at least 
60 days before their entry into force. Where considerations of safety, health or 
environmental  protection  require  more  urgent action,  a Party  shall  notify  the 
other Party as soon as practicable. 

3.  Each  Party  shall  promptly  notify  the  other  Party  of  any  changes  to  its 

Designating Authorities and/or conformity assessment bodies. 

4.  The  Parties  shall  exchange  information  concerning  the  procedures  used  to 
ensure that the  listed  conformity  assessment  bodies  under their  responsibility 
comply with the legislative, regulatory, and administrative provisions  outlined 
in the Sectoral Annexes. 

5.  Regulatory  Authorities  identified  in  the  Sectoral  Annexes  shall  consult  as 
necessary  with their counterparts, to ensure the maintenance  of confidence  in 
conformity assessment procedures and to ensure that all technical requirements 
are identified and are satisfactorily addressed. 

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Article 13 

SECTORAL CONTACT POINTS 

Each Party shall appoint and confirm in writing contact points to be responsible for 
activities under each Sectoral Annex. 

Article 14 

JOINT COMMITTEE OF THE PARTIES 

1.  The Parties hereby establish a Joint Committee consisting of representatives of 
each  Party.  The  Joint  Committee  shall  be  responsible  for  the  effective 
functioning of the Agreement. 

2.  The Joint  Committee  may establish  Joint  Sectoral  Committees  comprised  of 

appropriate Regulatory Authorities and others deemed necessary. 

3.  Each Party shall have one vote in the Joint Committee. The Joint  Committee 
shall  make  its  decisions  by  unanimous  consent.  The  Joint  Committee  shall 
determine its own rules and procedures. 

4.  The  Joint  Committee  may  consider  any  matter  relating  to  the  effective 

functioning of this Agreement. In particular it shall be responsible for: 

a) 

listing, suspension, withdrawal and verification  of conformity  assessment 
bodies in accordance with this Agreement; 

b)  amending transitional arrangements in Sectoral Annexes; 

c) 

resolving any questions relating to the application of this Agreement and 
its  Sectoral  Annexes  not  otherwise  resolved  in  the  respective  Joint 
Sectoral Committees; 

d)  providing a forum  for  discussion of issues that may arise concerning  the 

implementation of this Agreement; 

e)  considering ways to enhance the operation of this Agreement; 

0 

coordinating the negotiation of additional Sectoral Annexes; and 

g)  considering whether to amend this Agreement or its Sectoral  Annexes in 

accordance with Article 21. 

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5.  When a Party introduces new or additional conformity  assessment  procedures 
affecting  a  Sectoral  Annex, the  Parties  shall  discuss  the  matter  in  the  Joint 
Committee with a view to bringing such new or additional  procedures within 
the scope of this Agreement and the relevant Sectoral Annex. 

Article 15 

PRESERVATION OF REGULATORY AUTHORITY 

1.  Nothing in this Agreement shall be construed to limit the authority of a Party 
to determine, through  its legislative, regulatory  and  administrative  measures, 
the  level  of  protection  it  considers  appropriate  for  safety;  for  protection  of 
human, animal, or plant life or health; for the environment; for consumers; and 
otherwise  with  regard  to  risks  within  the  scope  of  the  applicable  Sectoral 
Annex. 

2.  Nothing  in  this  Agreement  shall  be  construed  to  limit  the  authority  of  a 
Regulatory  Authority  to  take  all  appropriate  and  immediate  measures 
whenever it ascertains that a product may: (a) compromise the health or safety 
of  persons  in  its  territory;  (b)  not  meet  the  legislative,  regulatory,  or 
administrative provisions within the scope of the applicable Sectoral Annex; or 
(c) otherwise  fail  to  satisfy  a requirement  within  the scope of the  applicable 
Sectoral  Annex.  Such  measures  may  include  withdrawing  the products from 
the  market,  prohibiting  their  placement  on  the  market,  restricting  their  free 
movement,  initiating  a product  recall, and preventing  the recurrence  of such 
problems,  including  through  a  prohibition  on  imports.  If  the  Regulatory 
Authority  takes  such  action,  it shall  inform  its counterpart  authority  and  the 
other Party within fifteen  days of taking such action, providing its reasons. 

Article 16 

SUSPENSION OF RECOGNITION OBLIGATIONS 

Either  Party  may  suspend  its  obligations  under  a  particular  Sectoral  Annex,  in 
whole or in part, if: 

a)  a Party suffers a loss of market access for the Party's products within the scope 
of the Sectoral  Annex as a result of the failure  of the other Party to fulfill  its 
obligations under the Agreement; 

b) 

the  adoption  of  new  or  additional  conformity  assessment  requirements  as 
referenced  in  Article  14(5) results  in  a loss of  market  access  for  the  Party's 
products  within  the  scope  of  the  Sectoral  Annex  because  conformity 
assessment bodies designated by the Party in order to meet such requirements 
have not been recognized by the Party implementing the requirements; or 

II 

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c) 

the  other  Party  fails  to  maintain  legal  and  regulatory  authorities  capable  of 
implementing the provisions of this Agreement. 

Article 17 

CONFIDENTIALITY 

1.  Each  Party  agrees  to  maintain,  to  the  extent  required  under  its  laws,  the 

confidentiality of information exchanged under this Agreement. 

2. 

In particular, neither Party shall disclose to the public, nor permit a conformity 
assessment  body to disclose  to the public, information  exchanged  under this 
Agreement that constitutes trade secrets, confidential  commercial  or  financial 
information, or information that relates to an ongoing investigation. 

3.  A Party or a conformity  assessment body may, upon exchanging  information 
with the other Party or with a conformity  assessment body of the other Party, 
designate the portions of the information  that it considers to be exempt from 
disclosure. 

4.  Each  Party  shall  take  all  precautions  reasonably  necessary  to  protect 
information exchanged under this Agreement from unauthorized disclosure. 

Article 18 

FEES 

Each  Party  shall  endeavor  to  ensure  that  fees  imposed  for  services  under  this 
Agreement  shall  be  commensurate  with  the  services  provided.  Each  Party  shall 
ensure  that,  for  the  sectors  and  conformity  assessment  procedures  covered  under 
this  Agreement,  it  shall  charge  no  fees  with  respect  to  conformity  assessment 
services provided by the other Party. 

Article 19 

AGREEMENTS WITH OTHER COUNTRIES 

Except where there is written agreement between the Parties, obligations contained 
in  mutual  recognition  agreements  concluded  by  either  Party  with  a  party  not  a 
signatory  to  this  Agreement  (a  third  party)  shall  have  no  force  and  effect  with 
regard  to  the  other  Party  in  terms  of  acceptance  of  the  results  of  conformity 
assessment procedures in the third party. 

12 

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Article 20 

TERRITORIAL APPLICATION 

This Agreement shall apply, on the one hand, to the territories in which the Treaty 
establishing  the  European  Community  is  applied,  and  under  the  conditions  laid 
down in that Treaty and, on the other hand, to the territory of the United States. 

Article 21 

ENTRY INTO FORCE, AMENDMENT AND TERMINATION 

1.  This  Agreement  including  its  Sectoral  Annexes  on  Telecommunications 
Equipment,  Electromagnetic  Compatibility,  Electrical  Safety,  Recreational 
Craft,  Pharmaceutical  GMP Inspections, and Medical Devices shall enter into 
force  on the first day  of the  second  month  following  the  date  on which  the 
Parties have exchanged  letters  confirming  the  completion  of their  respective 
procedures for the entry into force of this Agreement. 

2.  This  Agreement  including  any  Sectoral  Annex  may,  through  the  Joint 
Committee,  be  amended  in  writing  by  the  Parties.  The Parties  may  add  a 
Sectoral Annex upon the exchange of letters. Such Annex shall enter into force 
30  days  following  the  date  on  which  the  Parties  have  exchanged  letters 
confirming  the  completion  of  their  respective  procedures  for  the  entry  into 
force of the Sectoral Annex. 

3.  Either  Party  may  terminate .this Agreement  in  its  entirety  or  any  individual 
Sectoral Annex thereof by giving the other Party six months notice in writing. 
In the case of termination  of one or more Sectoral  Annexes, the  Parties will 
seek  to  achieve  by  consensus  to  amend  this  Agreement,  with  a  view  to 
preserving the remaining Sectoral Annexes, in accordance with the procedures 
in this Article. Failing  such consensus, the Agreement  shall  terminate  at the 
end of six months. 

4.  Following  termination  of  the  Agreement  in  its  entirety  or  any  individual 
Sectoral  Annex  thereof,  a  Party  shall  continue  to  accept  the  results  of 
conformity assessment procedures performed by conformity assessment bodies 
under  this  Agreement  prior  to termination,  unless a  Regulatory  Authority  in 
the  Party  decides  otherwise  based  on  health,  safety  and  environmental 
considerations or failure  to satisfy  other requirements within the scope of the 
applicable Sectoral Annex. 

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Article 22 

FINAL PROVISIONS 

1.  The Sectoral Annexes referred  to in Article 21.1, as well as any New Sectoral 
Annexes  added  pursuant  to  Article  21.2,  shall  form  an  integral  part  of  this 
Agreement. 

2.  For a given product or sector, the provisions contained in the relevant Sectoral 
Annexes  shall  apply  in  the  first  place,  and  the  provisions  of  this  text  in 
addition  to  those  provisions.  In  the  case  of  any  inconsistency  between  the 
provisions of a Sectoral Annex and this text, the Sectoral Annex shall prevail, 
to the extent of that inconsistency. 

3.  This Agreement shall not affect  the rights and obligations of the Parties under 

any other international agreement. 

4. 

In the case of the Sectoral Annex on Medical Devices, the Parties shall review 
the status of such Annex at the end of three years from entry into force. 

This  Agreement  and  the  Sectoral  Annexes  are  drawn  up  in two  originals  in  the 
Danish,  Dutch,  English,  Finnish,  French,  German,  Greek,  Italian,  Portuguese, 
Spanish and Swedish languages, each text being equally authentic. In the event of 
inconsistencies of interpretation, the English text shall be determinative. 

DONE at 

this 

day of 

, 1997. 

FOR  THE  GOVERNMENT  OF  THE  FOR THE EUROPEAN COMMUNITY: 
UNITED STATES OF AMERICA: 

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US - EC  MRA Telecommunication  Equipment Annex 

EC - U.S. MRA 

SECTORAL ANNEX 

FOR 

TELECOMMUNICATION  EQUIPMENT 

PREAMBLE 

Recognizing that this Annex constitutes a Sectoral Annex to the Agreement on Mutual 
Recognition of Conformity Assessment between the United States and the European 
Community, 

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US - EC  MRA Telecommunication  Equipment Annex 

SECTION I 

LEGISLATIVE, REGULATORY AND ADMINISTRATIVE PROVISIONS 

EC 

U.S. 

Communication Act of  1934, as amended by 
the Telecommunication Act of 1996,  (Title 
47 of the United States Code), 

the U.S. regulatory and administrative 
provisions in respect of telecommunication 
equipment, including 47 CFR Part 68, and 
FCC interpretation thereof; 

(The Parties recognize that the FCC Form 
730 Application Guide provides useful 
guidelines for the implementation of 
conformity assessment procedures for 
telecommunication terminal equipment 
falling within these regulations.); 

The U.S. regulatory and administrative 
provisions in respect of all radio transmitters 
subject to an equipment authorization 
requirement. A non-exclusive list of FCC 
regulations are contained in Section II; 

For electrical safety, see Electrical  Safety 
Sectoral Annex to the Agreement; 

For electromagnetic compatibility aspects, 
see Electromagnetic Compatibility (EMC) 
Sectoral Annex to the Agreement, 

Council Directive 91/263/EEC, as 
supplemented by Council Directive 
93/97/EEC and amended by Council 
Directive 93/68/EEC, and interpretation 
thereof; 

(The Parties recognize that the Handbook 
on the implementation of Directive 
91 /263/EEC (ADLNB and ACTE 
approved), provides useful guidelines for 
the implementation of  conformity 
assessment procedures falling under this 
Directive.); 

Commission Decisions (CTRs) established 
under Council Directives 91/263/EEC and 
•»' 
93/97/EEC; 

The EC Member States' legislation and 
regulations in respect of: 
(a) non-harmonized analogue connection to 
the public telecommunications network*; 
(b) non-harmonized radio transmitters-for 
which there is a civilian equipment 
authorization requirement; 

*  The EC agrees to seek authority to 
include non-harmonized digital 
connections; 

For electrical safety, see Electrical Safety 
Sectoral Annex to the Agreement; 

For electromagnetic compatibility aspects, 
see Electromagnetic Compatibility (EMC) 
Sectoral Annex to the Agreement. 

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US - EC  MRA Telecommunication Equipment Annex 

SECTION II 

SCOPE AND COVERAGE 

This Sectoral Annex shall apply to equipment, interfaces, and services subject 
to Section I.  In general terms the provisions of this Sectoral Annex shall apply 
to  the  following  types  of  telecommunications  terminal  equipment,  satellite 
terminal  equipment, 
technology 
equipment: 

transmitters,  and 

information 

radio 

(a) 

equipment intended for connection to the public telecommunications 
network in order to send, process or receive information, whether the 
equipment is to be connected directly to the "termination" of the 
network or to inter-work with such a network, being connected directly 
or indirectly to the termination point.  The system of connection may 
be wire, radio, optical or other electro-magnetic means; 

(b) 

equipment capable of being connected to a public telecommunications 
network even if it is not its intended purpose, including information 
technology equipment having a communication port; and 

(c) 

all  radio transmitters subject to an equipment authorization procedure 
by either Party. 

The following is a non-exclusive list of the equipment, interfaces, and services 
included within the scope of this Sectoral Annex: 

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US - EC  MRA Telecommunication  Equipment Annex 

SECTION II (continued) 

SCOPE AND COVERAGE 

EC 

The following equipment categories 
are included : 
ISDN Basic Rate Access 
ISDN Primary Rate Access 
ISDN Telephony 
X21/V.24/V.35 Access 
X25 Access 
PSTN Non-Voice 
PSTN Voice Band (Analog) 
ONP Leased Line Terminal types : 
-64 kbits/sec 
-2048 kbits/s unstructured 
-2048 kbits/s structured 
-34 Mbits/s access 
-140 Mbits/s access 
-2 wire analogue 
-4 wire analogue 

* 

Radio transmitters subject to an 
equipment authorization 
requirement, including: 

U S. 

Equipment categories covered under 47 CFR Part 
68,  including: 
ISDN Basic Access 
ISDN Primary Rate Access 
Digital Service Access : 
2.4 kbps 
3.2 kbps (2.4 kbps with Secondary Channel) 
4.8 kbps 
6.4 kbps (4.8 kbps with SC) 
9.6 kbps 
12.8 kbps (9.6 kbps with SC) 
19.2 kbps 
25.0 kbps (19.2 kbps with SC) 
56.0 kbps 
64.0 kbps  (uses 72 kbps channel) 
72.0 kbps (56.0 kbps with SC) 

1.544 Mbps 

2 wires analog tie trunks/ops 
4 wire analog tie trunks/ops 
PSTN Voice Band (Analog) Access 
Private Line (Analog) Access 

(List to be provided before signing  Radio transmitters subject to an equipment 
of Sectoral Annex.) 

(Part 20) 
(Part 21) 
(Part 22) 

authorization requirement, including: 
Commercial Mobile Radio 
Domestic Public Fixed 
Domestic Mobile 
Personal Communication Service  (Part 24) 
Satellite Communications 
Broadcast 
Auxiliary Broadcast 
Cable Television Radio 
Maritime 
GMDSS 
Private Land Mobile 
Private-Fixed Microwave 
Personal Radio Services 
IVDS 
Amateur Radio 
Radio Frequency Devices 
Fixed Microwave Services 

(Part 25) 
(Part 73) 
(Part 74) 
(Part 78) 
(Part 80) 
(Part 80W) 
(Part 90) 
(Part 94) 
(Part 95) 
(Part 95 F) 
(Part 97) 
(Part 15) 
(Part  101) 

Note: A list of acronyms and a glossary is contained in Appendix I to this Sectoral 
Annex. 

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US - EC  MRA Telecommunication  Equipment Annex 

SECTION III 

CONFORMITY ASSESSMENT  PROCEDURES 
FOR TELECOMMUNICATION  EQUIPMENT 

1. 

Description of Mutual Recognition Obligations 

In accordance with the provisions of the Agreement, the results of the conformity  assessment 
procedures produced by a Party's conformity  assessment bodies listed  in Section  V.shall be 
recognized  by the Regulatory  Authorities of the other Party without  any  further  conformity 
assessment of the products, pursuant to Section I. 

2, 

Conformity Assessment Procedures 

Taking into account the legislative, regulatory, and administrative provisions as identified  in 
Section  I, each  Party  recognizes  that  the conformity  assessment  bodies  of  the  other  Party, 
listed  in Section  V, are authorized  to perform  the following  procedures with  regard  to the 
importing  Party's  technical  requirements  for  telecommunications  terminal  equipment, 
satellite terminal equipment, radio transmitters or information  technology equipment: 

a) 

b) 

c) 

testing and issuing of test reports; 

issuing  certificates  of  conformity  to  the  requirements  of  the  laws  and 
regulations  applicable  in the  territories  of  the  Parties  for  products  covered 
under this Sectoral Annex; and 

performing quality assurance certification  pursuant to Council Directive 
91/263/EEC. 

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US  - EC  MRA  Telecommunication  Equipment  Annex 

SECTION IV 

AUTHORITIES  RESPONSIBLE FOR DESIGNATING  THE 
CONFORMITY  ASSESSMENT BODIES LISTED IN SECTION V 

EC 

U.S. 

National Institute of 
Standards and 
Technology  (NIST) 

Federal 
Communications 
Commission (FCC) 

Austria: 
Bundesministerium furWissenschaft,Verkehr  und Lumst. 

Belgium: 
BIPT. 

Denmark: 
Telestyrelsen. 

Finland: 
Telecommunications  Administration Centre. 

Germany: 
Bundesministerium fur Wirtschaft  (Bonn) 

Greece: 
Ministry of Transport & Communications. 

France: 
Direction Generate des Postes & Telecommunications 

Ireland: 
Dept. of Transport, Energy  & Communications. 

Italy: 
Ispettorato General TLC. 

Luxembourg: 
Administration des Postes et Telecommunications. 

Netherlands: 
Min. Verkeer en Waterstaat, Telecom, en Post  Department. 

Portugal: 
Instituto das Communicacoes. 

Spain: 
Ministerio de Formento 

Sweden: 
National Post & Telecom Agency + SWEDAC. 

UK: 

I  Dept of Trade & Industry  . 

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US -  EC  MRA  Telecommunication  Equipment  Annex 

SECTION V 

CONFORMITY ASSESSMENT BODIES 

EC 

US; 

Conformity  assessment bodies located  in 
the EC shall be designated  by the 
Authorities  identified  in Section  IV 
following the procedures set out in Section 
VI of this Annex. 

Conformity  assessment  bodies located  in 
the U.S. shall  be designated  by the 
Authorities  identified  in Section  IV 
following  the procedures set out  in Section 
VI of this Annex. 

(to be provided  by the EC upon notification 
by the Member States). 

(to be provided  by the U.S.) 

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US - EC  MRA Telecommunication  Equipment Annex 

SECTION VI 

DESIGNATING, LISTING, SUSPENDING, WITHDRAWING AND MONITORING 
CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V 

EC 

U.S. 

EC Access to U.S. Market: 

U.S. Access to EC Market: 

EC Authorities identified  in Section IV 
shall designate conformity assessment 
bodies located in the EC in accordance with 
the U.S. legislative, regulatory, and 
administrative provisions identified in 
Section I that govern designation of 
conformity assessment bodies, based on 
compliance with the appropriate ISO/IEC 
Guides (e.g. Guide 22,  25, 28, 58, 61, 62, 
6J, etc.) or the comparable EN-45000 Series 
Standards. 

U.S. Authorities identified  in Section IV 
shall designate conformity assessment 
bodies located in the U.S. in accordance 
with the EC legislative, regulatory, and 
administrative provisions identified in 
Section I that govern designation of 
conformity assessment bodies, based on 
compliance with the appropriate EN-45000 
Series Standards or the comparable 
ISO/IEC Guides (e.g. Guide 22,  25, 28, 58, 
61, 62, 65, etc.). 

Procedures for designating, listing, 
suspending, withdrawing, and monitoring a 
conformity assessment body listed in 
Section V shall be undertaken pursuant to 
Articles 7, 8, 9, and  10 of the Agreement. 

Procedures for designating, listing, 
suspending, withdrawing, and monitoring a 
conformity assessment body listed in 
Section V shall be undertaken pursuant to 
Articles 7, 8, 9, and  10 of the Agreement. 

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US - EC  MRA  Telecommunication  Equipment  Annex 

SECTION VII 

ADDITIONAL  PROVISIONS 

1.  SUB - CONTRACTING 

1.1 Any sub-contracting by conformity  assessment bodies shall be in accordance with 
the sub-contracting requirements of the other Party.  Notwithstanding  the use of 
sub-contracting, the final  results of conformity  assessment  remain the  full 
responsibility of the listed conformity  assessment  body.  In the EC, these 
requirements are described  in Council Decision 93/465/EEC. 

1.2 The conformity  assessment  bodies shall record and retain details of their 

investigation  of the competence and compliance of their subcontractors and  maintain 
a register of all sub-contracting.  These details will be available to the other Party on 
request. 

2.  POST-MARKET SURVEILLANCE,  BORDER MEASURES AND  INTERNAL 

MOVEMENT 

2.1  For the purpose of post-market surveillance, the Parties may maintain any existing 
labeling and numbering requirements.  The assignment of the numbers may take 
place  in the territory of the exporting Party.  The numbers will be allocated  by the 
importing Party.  Numbering and labeling systems shall not introduce additional 
requirements within the meaning of this Sectoral Annex. 

2.2  Nothing  in this Sectoral Annex shall prevent the Parties from  removing  products 
from  the market that do not in fact conform  to the requirements for  approval. 

2.3  The Parties agree that border  inspections and checks of products which have been 

certified,  labeled or marked as conforming  with the importing Party's  requirements 
specified  in Section  I shall be completed as expeditiously as possible.  With regard to 
any inspections related to internal movement within their respective territories, the 
Parties agree that these shall be completed  in no less a favorable  manner than  for 
like-domestic goods. 

3.  JOINT SECTORAL  COMMITTEE 

3.1  A combined Joint Sectoral Committee for this Sectoral Annex and the EMC  Sectoral 
Annex is hereby established (the JSC).  The JSC shall operate during the transitional 
period and after  completion  of the transitional  arrangement.  The JSC shall  meet as 
appropriate to discuss technical, conformity  assessment and technology  issues 
relating to this Sectoral  Annex and the EMC Sectoral  Annexes.  The JSC shall 
determine  its own rules of procedure. 

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US - EC  MRA Telecommunication  Equipment Annex 

3.2  The JSC consists of representatives of the U.S. and the EC for telecommunications 
and EMC.  JSC representatives may each invite manufacturers and other entities as 
deemed necessary. The representatives for the U.S. shall have one vote in the JSC. 
The representatives of the EC shall have one vote in the JSC.  Decisions of the JSC 
shall be made by unanimous consent.  In the event of disagreement either the U.S. or 
EC representative may raise the matter in the Joint Committee. 

3.3 The JSC may address any matter related to the effective  functioning  of this Sectoral 

Annex, including: 

a) providing a forum for discussion of issues and resolving problems that may 
arise concerning the implementation of this Sectoral Annex; 

b) developing a mechanism for ensuring consistency of interpretations of 
legislation, regulations, standards, and conformity assessment procedures; 

c) advising the Parties on matters relating to this Sectoral Annex; and 

d) providing guidance and, if necessary, developing guidelines during the 
transitional period to facilitate the successful  completion of the transitional 
period. 

4.  CONTACT POINT 

Each Party shall establish a contact point to provide answers to all reasonable inquiries from 
the other Party regarding procedures, regulations, and complaints under this Sectoral Annex. 

5.  REGULATORY CHANGES AND UPDATING THE SECTORAL ANNEX 

In the event that there are changes to the legislative, regulatory, and administrative provisions 
referenced  in Section I or the introduction of new legislative, regulatory, and administrative 
provisions affecting  either Party's conformity assessment procedures under the Agreement, 
such changes shall take effect  for the purpose of this Sectoral Annex at the same time they 
take effect  domestically within the territory of each Party.  The Parties shall update this 
Sectoral Annex to reflect the changes. 

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US - EC  MRA  Telecommunication  Equipment  Annex 

SECTION VIII 

TRANSITIONAL  ARRANGEMENT 

1.  There shall be a transitional period of 24 months. 

2.  The purpose of this transitional  arrangement  is to provide a means whereby the Parties to 
the Agreement can build confidence  in and an understanding of each other's system  for 
designating and listing conformity  assessment bodies and  in the ability of these bodies to 
test and certify  products.  Successful  completion  of the transitional arrangement  should 
result  in the determination that conformity  assessment  bodies listed  in Section  V comply 
with the applicable criteria and are competent to conduct conformity  assessment 
activities on behalf of the other Party. Upon successful  completion  of the transition 
period, the results of conformity  assessment procedures performed  by the exporting 
Party's conformity  assessment  bodies listed  in Section V of the exporting country  shall 
be accepted  by the importing Party. 

3.  This transitional  period shall be used by the Parties: 

a) 

to consider new legislative changes needed to support the objectives  of the 
Agreement; 

d) 

b)  to initiate regulatory changes needed to support the objectives  of the  Agreement; 
to exchange  information  on and develop better understanding of their  respective 
c) 
regulatory  requirements; 
to develop mutually agreed mechanisms for exchanging  information  on changes in 
technical  requirements or methods of designating conformity  assessment bodies; and 
to monitor and evaluate the performance  of the listed conformity  assessment  bodies 
during the transitional  period. 

e) 

4.  Parties may designate, list, suspend and withdraw conformity  assessment  bodies during 
the transitional  period according to the procedures in Section VI of this Sectoral  Annex. 

5.  During the transitional  period each Party shall accept and evaluate test reports and 

related documents issued by designated conformity  assessment  bodies of the other  Party. 
To this end, the Parties shall ensure that: 
a)  on receipt of test reports, related documents and a first  evaluation  of conformity,  the 

dossiers are promptly examined  for completeness; 
the applicant  is informed  in a precise and complete manner of any  deficiency; 
b) 
c)  any request  for additional  information  is limited to omissions, inconsistencies or 

variances from  the technical  regulations or standards; and 

d)  procedures for assessing the conformity  for equipment  modified  subsequent to a 
determination  of compliance, are limited to procedures necessary to determine 
continued  conformance. 

6.  Each  Party ensures that  issuance of approvals, certificates,  or advice to the applicant 

shall  be given  no later than six weeks from  receipt of the test report and evaluation  from 
a designated  conformity  assessment  body in the territory of the other Party. 

25 

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7.  Any proposal made during or at the end of the transitional period to limit the scope of 
recognition of any designated conformity assessment body or to exclude it from the list 
of bodies designated under this Sectoral Annex shall be based on objective criteria and 
documented.  Any such body may apply for reconsideration once the necessary 
corrective action has been taken.  To the extent possible, the Parties shall implement such 
action prior to the expiry of the transitional period. 

8.  The Parties may jointly sponsor two seminars, one in the U.S. and one in the European 

Community, concerning the relevant technical and product approval requirements during 
the first year after this Sectoral Annex enters into force. 

9.  Passage from the transitional phase into the operational phase in this Sectoral Annex 

shall take place provided that a representative number of conformity assessment bodies 
have been accepted for recognition under the Electrical Safety Annex. 

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APPENDIX 1 

LISTS OF ACRONYMS AND GLOSSARY 

Approvals Committee for Terminal Equipment 
ACTE 
ADLNB  Association of Designated Laboratories and Notified  Bodies 
CAB 
CFR 
CTR 
EC 
EEC 
EN 
EU 
FCC 
IEC 
ISDN 
ISO 
ITU 
MRA 
MS 
NB 
NIST 
OJ 
ONP 
PSTN 
STG 
TBR 
X21 
X25 

Conformity Assessment Body 
U.S. Code of Federal Regulations, Title 47 CFR 
Common Technical Regulation 
European Community 
European Economic Community 
Norme Européenne (European Standard) 
European Union 
Federal Communications Commission 
International Electrotechnical Commission 
Integrated Services Digital Network 
International Standards Organization 
International Telecommunications Union 
Mutual Recognition Agreement 
Member States (of the European Union) 
Notified  Bodies 
National Institute of Standards and Technology 
Official  Journal (of the European Union) 
Open Network Provision 
Public Switched Telephone Network 
Sectoral Technical Group for Telecommunications 
Technical Basis for Regulation 
ITU-T Recommendation X21 
ITU-T Recommendation X25 

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EU - U.S. MRA 

SECTORAL ANNEX 

FOR 

ELECTROMAGNETIC COMPATIBILITY 

(EMC) 

PREAMBLE 

Recognizing  that  this  Annex  constitutes  a  Sectoral  Annex  to  the  framework 
Agreement  on  Mutual  Recognition  of  Conformity  Assessment  between  the  United 
States and the European Community. 

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SECTION I 

LEGISLATIVE, REGULATORY AND ADMINISTRATIVE  PROVISIONS 

EC 

U.S. 

Council  Directive  89/336/EEC,  as  amended  by 
Council  Directives  91/263/EEC,  92/31/EEC, 
interpretation 
93/68/EEC  and  93/97/EEC  and 
thereof. 

For  electrical  safety  aspects  see  Electrical  Safety 
Sectoral Annex to the Agreement. 

telecommunication  equipment  and  radio 
also  Telecommunications 

For 
transmitters, 
Equipment Sectoral Annex to the Agreement. 

see 

of 

Communications  Act 
as 
amended  by -the  Telecommunication  Act 
of  1996,  (Title  47  of  the  United  States 
Code), 

1934. 

the  U.S.  regulatory  and  administrative 
provisions in respect of equipment  subject 
to 
requirements 
including: 

electromagnetic 

- 4 7 C F R P a r t l5 
- 4 7 C F R P a r t l 8, 

and FCC interpretation  thereof. 

For electrical -safety  aspects  see  Electrical 
Safety  Sectoral Annex to the  Agreement. 

For  telecommunication  equipment  and 
radio 
also 
Telecommunications  Equipment  Sectoral 
Annex to the Agreement. 

transmitters, 

see 

SECTION II 

SCOPE AND COVERAGE 

EC 

US. 

For US access to the EU market: 

For EU access to the US market: 

Any  product  falling  under  the  scope  of  Any  products  falling  under  the  scope  of 
Council  Directive 89/336/EEC. 

47 CFR Part  15 and  18. 

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SECTION III 

CONFORMITY ASSESSMENT PROCEDURES 
FOR EQUIPMENT IDENTIFIED IN SECTION II 

1. 

Description of Mutual Recognition Obligations 

In  accordance  with  the  provisions  of  the  Agreement,  the  results  of  the  conformity 
assessment procedures produced by a Party's conformity  assessment bodies listed in 
Section  V,  shall  be  recognized  by  the  Regulatory  Authorities  of  the  other  Party 
without any further conformity assessment of the products, pursuant to Section I. 

2. 

Conformity Assessment Procedures 

Taking  into  account  the  legislative,  regulatory,  and  administrative  provisions  as 
identified  in Section I, each Party recognizes that the conformity  assessment bodies of 
the  other  Party,  listed  in  Section  V,  are  authorized  to  perform  the  following 
procedures with regard to the importing Party's technical requirements for equipment 
identified  in Section II: 

a) 

testing and issuing of test reports; 

b) 

issuing  certificates  of  conformity  to  the  requirements  of  the  laws  and 
regulations  applicable  in  the  territories  of  the  Parties  for  products  covered 
under this Sectoral Annex. 

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SECTION IV 

AUTHORITIES RESPONSIBLE FOR DESIGNATING THE 
CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V 

EU 

Ujj. 

Austria: 

Bundesministerium fur 

wirtschaftliche Angelegenheiten 

National Institute of Standards and 
Technology (NIST) 

Federal Communications Commission 
(FCC) 

Federal Aviation Administration 
(FA A) 

Abteilung 

Belgium: 
Denmark: 
Finland: 
France: 
Germany: 

Greece: 
Ireland: 

Italy: 
Luxemburg: 
Netherlands: 

Portugal: 
Spain: 
Sweden: 

U.K.: 

(list to be completed later) 

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SECTION V 

CONFORMITY ASSESSMENT BODIES 

EC 

ILS. 

For EC access to the U.S.  market: 

For U.S.  access to the EC market: 

Conformity  assessment  bodies located  in  Conformity  assessment  bodies  located 
in the U.S. shall  be designated  by the 
the  EC  shall  be  designated  by  the 
Authorities 
in  Section  IV 
following  the  procedures  set  out  in 
following 
Section VI of this Annex. 
Section VI of this Annex. 

in  Section  IV  Authorities  identified 

the  procedures  set  out  in 

identified 

(to be provided by the EC) 

(to be provided by the U.S.) 

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SECTION VI 

DESIGNATING, LISTING, SUSPENDING, WITHDRAWING AND 
MONITORING 
CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V 

EC Access to U.S. Market: 

U.S. Access to EC Market: 

EC 

U.S. 

legislative, 

EC  Authorities  identified  in  Section  IV 
shall  designate  conformity  assessment 
bodes located in the EC in accordance with 
regulatory^  and 
the  U.S. 
administrative  provisions 
in 
identified 
Section  I  that  govern  designation  of 
conformity  assessment  bodies, based  upon 
compliance  with  the  appropriate  ISO/IEC 
Guides  (e.g. Guide 22, 25, 28, 58, 61,  62, 
65,  etc.)  or  the  comparable  EN-45000 
Series Standards. 

U.S.  Authorities  identified  in  Section  IV 
shall  designate  conformity  assessment 
bodies  located  in  the  U.S.  in  accordance 
with  the  EC  legislative,  regulatory,  and 
administrative  provisions 
in 
Section  I  that  govern  designation  of 
conformity  assessment  bodies,  based  on 
compliance with the appropriate EN-45000 
Series  Standards  or 
the  comparable 
ISO/IEC Guides (e.g. Guide 22, 25, 28, 58, 
61, 62, 65, etc.). 

identified 

for 

designating, 

Procedures 
listing, 
suspending, withdrawing, and monitoring a 
conformity  assessment  body 
in 
Section  V shall  be undertaken  pursuant  to 
Articles 7, 8, 9, and 10 of the Agreement. 

listed 

for 

designating, 

Procedures 
listing, 
suspending, withdrawing, and monitoring a 
conformity  assessment  body 
in 
Section  V shall  be undertaken  pursuant  to 
Articles 7, 8, 9, and 10 of the Agreement. 

listed 

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SECTION VII 
ADDITIONAL PROVISIONS 

1. 

SUB - CONTRACTING 

1.1  Any sub-contracting  by conformity  assessment  bodies shall be in accordance 
with the sub-contracting requirements of the other Party. Notwithstanding the 
use of sub-contracting, the final  results of conformity  assessment  remain  the 
full  responsibility  of the listed conformity  assessment  body. In the EC, these 
requirements are described in Council Decision 93/465/EEC. 

1.2  The  conformity  assessment  bodies  shall  record  and  retain  details  of  its 
investigation  of  the  competence  and  compliance  of  its  subcontractors  and 
maintain a register of ail sub-contracting. These details will be available to the 
other Party on request. 

2. 

POST-MARKET SURVEILLANCE, BORDER MEASURES AND 

INTERNAL MOVEMENT 

2.1  For  the  purpose  of  post-market  surveillance,  the  Parties  may  maintain  any 
existing labeling and numbering requirements. The assignment of the numbers 
may take place  in the territory  of  the  exporting  Party. The  numbers  will  be 
allocated  by the  importing  Party. Numbering  and  labeling  systems  shall  not 
introduce additional requirements within the meaning of this Sectoral Annex. 

2.2  Nothing  in  this  Sectoral  Annex  shall  prevent  the  Parties  from  removing 
products from the market that do not in fact  conform  to the requirements  for 
approval. 

2.3  The Parties agree that border inspections and checks of products which have 
been  certified,  labeled  or  marked  as  conforming  with  the  importing  Party's 
requirements  specified  in  Section  I  shall  be  completed  as  expeditiously  as 
possible. With regard  to any inspections related  to internal  movement  within 
their respective territories, the Parties agree that these shall be completed in no 
less a favorable manner than for like-domestic goods. 

3. 

JOINT SECTORAL COMMITTEE 

3.1  A  combined  Joint  Sectoral  Committee  for  this  Sectoral  Annex  and  the 
Telecommunications  Equipment  Sectoral  Annex  is  hereby  established  (the 
JSC). The JSC shall operate during the transitional period and after completion 
of the transitional  arrangement. The JSC shall meet as appropriate  to discuss 
technical,  conformity  assessment  and  technology  issues  relating  to  this 
Sectoral Annex and the Telecommunications  Equipment Sectoral  Annex. The 
JSC shall determine its own rules of procedure. 

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3.2  The  JSC  consists  of  representatives  of  the  U.S.  and 

the  EC  for 
telecommunications  and  EMC.  JSC  representatives  may  each 
invite 
manufacturers  and other entities as deemed necessary. The representatives  for 
the U.S. shall have one vote  in the JSC. The representatives  of the EC shall 
have one vote in the JSC. Decisions of the JSC shall be made by unanimous 
consent.  In  the  event  of  disagreement  either  the  U.S. or  EC  representatives 
may raise the matter in the Joint Committee. 

3.3  The JSC  may address  any matter  related  to  the  effective  functioning  of  this 

Sectoral Annex, including : 

a) 

b) 

c) 

d) 

providing  a  forum  for  discussion  of  issues  and  resolving 
problems  that  may  arise  concerning  the  implementation  of 
this Sectoral Annex; 

developing  a  mechanism  for  ensuring  consistency  of 
interpretations  of  legislation,  regulations,  standards,  and 
conformity assessment procedures. 

advising  the  Parties  on  matters  relating  to  this  Sectoral 
Annex; 

providing  guidance  and,  if necessary,  developing  guidelines 
during  the  transitional  period  to  facilitate  the  successful 
completion of the transitional period. 

4.  CONTACT POINT 

Each  Party  shall  establish  a  contact  point  to  provide  answers  to  all  reasonable 
inquiries from the other Party regarding procedures, regulations and complaints under 
this Sectoral Annex. 

5.  REGULATORY CHANGES AND UPDATING THE SECTORAL ANNEX 

In  the  event  that  there  are  changes  to  the  legislative,  regulatory  and  administrative 
provisions  referenced  in  Section  I or the  introduction  of  new  legislative,  regulatory 
and  administrative  provisions  affecting  either  Party's  conformity  assessment 
procedures under the Agreement, such changes shall take effect  for the purpose of this 
Sectoral  Annex at the same time they take effect  domestically  within the territory of 
each Party.  The Parties shall update this Sectoral Annex to reflect the changes. 

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SECTION VIII 

TRANSITIONAL  ARRANGEMENT 

1.  There shall be a transitional period of 24 months. 

2.  The  purpose  of  this  transitional  arrangement  is  to  provide  a  means  whereby  the 
Parties to the Agreement  can build confidence  in and  understanding  of each  others 
system  for  designating  and  listing  conformity  assessment  bodies  and  in the  ability 
of these bodies to test and certify  products.  Successful  completion  of the transition 
arrangement  should  result  in the  determination  that  conformity  assessment  bodies 
listed  in  Section  V  comply  with  the  applicable  criteria  and  are  competent  to 
conduct  conformity  assessment  activities  on  behalf  of  the  other  Party.  Upon 
completion  of  the  transition  period,  the  results  of  conformity  assessment 
procedures performed  by the exporting Party's conformity  assessment  bodies  listed 
in Section V shall be accepted by the importing Party. 

3.  This transitional period shall be used by the Parties : 

a)  to  consider  new  legislative  changes  needed  to  support  the  objectives  of  the 

Agreement; 

b) to  initiate  regulatory  changes  needed  to  support  the  objectives  of  the 

Agreement; 

c)  to  exchange  information  on  and  develop  better  understanding  of  their 

respective regulatory requirements; 

d)  to  develop  mutually  agreed  mechanisms  for  exchanging  information  on 
changes  in  technical  requirements  or  methods  of  designating  conformity 
assessment bodies; and 

e)  to  monitor  and  evaluate  the  performance  of  the  listed  conformity  assessment 

bodies during the transitional  period. 

4.  Parties  may  designate,  list,  suspend  and  withdraw  conformity  assessment  bodies 
during  the  transitional  period  according  to  the  procedures  in  Section  VI  of  this 
Sectoral Annex. 

5.  During the transitional  period  each Party shall  accept and evaluate test reports and 
related  documents  issued  by designated  conformity  assessment  bodies  of  the  other 
Party.  To this end, the Parties shall ensure that: 

-  on  receipt  of  test  reports,  related  documents  and  a  first  evaluation  of 

conformity,  the dossiers are promptly examined  for completeness; 
the applicant is informed  in a precise and complete manner of any  deficiency; 
- 
-  any  request  for  additional  information  is  limited  to omissions,  inconsistencies 

or variances from the technical regulations or standards; 

-  procedures  for  assessing the conformity  for  equipment  modified  subsequent  to 
a  determination  of  compliance,  are  limited  to  procedures  necessary  to 
determine continued  conformance; 

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US - EC  MRA Electromagnetic Compatib ility Annex 

6.  Each Party ensures that issuance of approvals, certificates or advice to the applicant 
shall be given no later than six weeks from receipt of the test report and evaluation 
from a designated conformity assessment body in the territory of the other Party. 

7.  Any proposal made during or at the end of the transitional period to limit the scope 
of recognition of any designated conformity  assessment body or to exclude it from 
the list of bodies designated under this Sectoral Annex shall be based on objective 
criteria and documented.  Any such body may apply  for  reconsideration  once the 
necessary corrective action has been taken.  To the extent possible, the Parties shall 
implement such action prior to the expiry of the transitional period. 

8.  The Parties may jointly sponsor two seminars, one in U.S. and one in the European 
Community, concerning the relevant technical  and product  approval  requirements 
during the first year after this Sectoral Annex enters into force. 

9.  Passage  from  the  transitional  phase  into  the  operational  phase  in  this  Sectoral 
Annex  shall  take  place  provided  that  a  representative  number  of  conformity 
assessment  bodies have been accepted  for  recognition  under the Electrical  Safety 
Annex. 

O 
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US - EC  MRA Electrical Safety Annex 

EC-U.S.  MRA 

SECTORAL ANNEX 

FOR 

ELECTRICAL SAFETY 

PREAMBLE 

Recognizing that this Annex constitutes a Sectoral Annex to the Agreement on Mutual 
Recognition between the United States and the European Community. 

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SECTION I 

LEGISLATIVE  REGULATORY AND ADMINISTRATIVE PROVISIONS 

EC 

IXS. 

For U.S.  access to the EC market: 

For EC access to the U.S.  market 

Council Directive 73/23/EEC of 19 February 
1973 as amended by  93/68/EEC. 

29 U.S.C. 651 et seq. 
U.S. 29 CFR 1910.7 

Products that are certified  or approved 
under the Federal Mine Safety and Health 
Act (30 U.S.C. 801 fiLsegJ or its 
regulations and used in areas under the 
authority of the Mine Safety and Health 
Administration, are not covered under this 
Annex. 

OSHA will consider regulatory and 
legislative changes needed to support the 
objectives of the MRA. 

For medical devices, see the Medical 
Devices Sectoral Annex to this 
Agreement. 

For medical devices, see the Medical Devices 
Sectoral Annex to this Agreement. 

For electromagnetic compatibility aspects, see the  For electromagnetic compatibility aspects. 
Electromagnetic Compatibility (EMC) Sectoral 
Annex to this Agreement. 

see the Electromagnetic Compatibility 
(EMC) Sectoral Annex to this Agreement. 

For telecommunications equipment, see the 
Telecommunications Equipment Sectoral Annex 
to this Agreement. 

For telecommunications equipment, see 
the Telecommunications Equipment 
Sectoral Annex to this Agreement. 

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SECTION II 

SCOPE AND COVERAGE 

EC 

U.S. 

For U.S.  access to the EC market: 

For EC access to the U.S.  market: 

The electrical safety requirements of products  The electrical safety requirements of 
products falling under the scope of 29 
falling under the scope of Council Directive 
73/23/EEC on the harmonization of the laws  CFR 1910 subpart S. This includes the 
electrical safety aspects for workplace 
of the Member States relating to electrical  ' 
safety of medical equipment and 
equipment designed for use within certain 
telecommunication terminal equipment 
voltage limits. 
within the scope of those Sectoral 
Annexes. 

Products that are certified or approved 
under the Federal Mine Safety and Health 
Act (30 U.S.C. 801 et seq.^ or its 
regulations and used in areas under the 
authority of the Mine Safety and Health 
Administration, are not covered under 
this Annex. 

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SECTION III 

DESCRIPTION OF MUTUAL RECOGNITION OBLIGATIONS 

In  accordance  with  the  provisions  of  the  Agreement,  EC  conformity  assessment 
bodies listed in Section V of this Annex shall be recognized to test, certify  and mark 
products within the scope of their NRTL recognition for assessing conformity  to U.S. 
requirements. 

With regard to U.S. conformity  assessment bodies listed in Section V of this Annex, 
in  the  event  of  a  challenge  within  the  European  Community  under  Article  8.2  of 
Council  Directive  73/23/EEC  of  19  February  1973,  test  reports  issued  by  such 
conformity  assessment  bodies  shall  be  accepted  by  the  European  Community 
Authorities in the same way that reports from  European Community Notified  Bodies 
are  accepted.  That  is,  (listed  conformity  assessment  bodies)  in  the  U.S.  shall  be 
recognized  under Article  11 of Council  Directive  73/23/EEC  as "bodies  which may 
make a report in accordance with Article 8." 

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SECTION IV 

AUTHORITIES  RESPONSIBLE FOR DESIGNATING  THE 
CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V 

U.S. 

For U.S. access to the EC 

market: 

National Institute for Standards 
and Technology (NIST) 

EC 

For EC access to the U.S. 
Market: 

Member States Authorities: 
Austria: 

' 

Belgium: 

Danmark: 
Finland: 
France:  - 

Germany: 

Greece: 
Ireland: 

Italy: 
Luxembourg: 
Netherlands: 
Portugal: 
Spain: 
Sweden: 

U. K. 

Bundesministerium fur 
wirtschaftiche Angelegenheiten 
Ministere des Affaires 
Economiques / Ministerie van 
Economische Zaken 
Elektricitetsraadet 
Ministry of Trade and Industry 
Ministere de l'^conomie, des 
finances et de 1'Industrie 
Bundesmin. fur Arbeit und 
Sozialordnung 
Ministry of Development 
Department of EnterpriseTrade and 
Employment 
Ministero dell' Industria 
Service de l'Energie de l'Etat 
Min van Economische Zaken 
Istituto Portugues da Qualidade 
Ministerio de Industria y Energia 
Styrelsen for Ackreditering och 
Teknisk Kontroll 
Department of Trade & Industry 

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US - EC  MRA Electrical Safety  Annex 

SECTION V 

CONFORMITY  ASSESSMENT  BODIES 

EC 

U.S. 

For EC access to the U.S.  market: 

For U.S.  access to the EC market: 

The  names  and  scope  of  responsibilities  of 
Conformity  Assessment  Bodies  located  in the EC 
and listed in accordance with this Sectoral Annex: 

The  names  and  scope  of  responsibilities  of 
Conformity  Assessment  Bodies  located  in 
the  U.S.  and  listed  in  accordance  with  this 
Sectoral Annex: 

[**  An  initial  list  of  Conformity  Assessment  Bodies  should  be  listed  in  this 
Section by the time we implement the Agreement.**] 

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SECTION VI 

DESIGNATING. LISTING. SUSPENDING AND WITHDRAWING 
CONFORMITY ASSESSMENT BODIES 

EC 

U.S. 

For EC access to the US.  market: 

For U.S.  access to the EC market: 

Conformity  assessment  bodies  from  the  EC shall 
be  designated  by  the  EC Authorities  identified  in 
Section 
the  Joint 
Committee,  in  accordance  with  the  recognition 
procedures in the Agreement and this Annex. 

IV  and  recognized 

by 

Conformance  with the appropriate ISO/IEC Guides 
or the  corresponding  EN 4500  series  of standards 
shall be deemed consistent with U.S. requirements 
identified  in Section I. 

For  purposes  of  designation  and  listing,  EC 
Designating  Authorities  identified  in  Section  IV 
shall  designate  conformity  assessment  bodies 
located  in  the  EC  by  filing  a  properly  prepared 
proposal  for  listing, which includes a complete lab 
assessment  under  the  U.S.  OSHA  procedures. 
OSHA  shall  notify  the  EC  Designating  Authority 
normally within 30 days as to whether the proposal 
is  complete  or  whether  additional  information  is 
required. 

rely  on 

OSHA  shall 
the.  EC  Designating 
Authorities identified  in Section IV for conducting 
on-site  reviews  at  the  respective  Member  States' 
conformity assessment bodies. 

Conformity  assessment  bodies  from  the 
U.S.  shall  be  designated  by  the  U.S. 
Authority  identified  in  Section  IV  and 
recognized  by  the  Joint  Committee,  in 
recognition 
accordance  with 
procedures  in the  Agreement  and  Council 
Directive 73/23/EEC. 

the 

series  of 

Conformance  with  the  appropriate  EN 
4500 
the 
corresponding  ISO/IEC  Guides  shall  be 
deemed  consistent  with  the  requirements 
of Council Directive 73/23/EEC. 

standards  or 

For purposes of designating and listing, the 
U.S.  Designating  Authority  identified  in 
Section  IV  shall  designate  conformity 
assessment  bodies  located  in  the  U.S. by 
filing  a  properly  prepared  proposal  for 
listing  with  the  EC,  which  includes  a 
the 
complete 
following EC or Member State procedures, 
as appropriate: 

lab  assessment  under 

The  EC shall  notify  the  U.S. Designating 
Authority within 30 days as to whether the 
proposal  is  complete  and  shall  indicate, 
additional 
any 
where 
information that is required. 

applicable, 

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SFCT1QN VI f continued^ 

EC 

U.S. 

Upon  receipt  of  a  complete  proposal,  the  U.S. 
exercising its authority under its law shall: 

in 

operational 

phase 
Equipment 

(a) prior  to the passage  from  the transitional  phase 
the 
into 
the 
Telecommunications 
and 
(EMC)  Sectoral 
Electromagnetic  Compatibility 
Annexes, give  notice  of  its consent  or  objection  to 
a proposed conformity  assessment body to the Joint 
Committee.  The  listing  of  an  agreed  conformity 
assessment  body  in  Section  V  of  this  Sectoral 
Annex shall only occur upon such passage from  the 
transitional  phase  into  the  operational  phase  of 
those Sectoral Annexes. 

Upon  receipt  of  a  complete  proposal,  the 
EC  shall  give  notice  of  consent  or 
objection  to the Joint  Committee  within  60 
days.  The  Joint  Committee  shall  monitor 
the  recognition  of  conformity  assessment 
bodies  and  confirm  such  a  recognition  by 
listing  them  in  Section  V  of  this  Sectoral 
Annex. 

The  U.S.  conformity  assessment  bodies 
listed  in  Section  V  shall  have  Notified 
Body status within the EC. 

in 

the  operational  phase 
Equipment 

(b)  subsequent  to  passage  from  the  transitional 
the 
into 
phase 
Telecommunications 
and 
Electromagnetic  Compatibility 
(EMC)  Sectoral 
Annexes, give  notice  of  its  consent  or objection  to 
a proposed conformity  assessment body to the Joint 
Committee normally within  120 business days. The 
listing  of an agreed  conformity  assessment  body  in 
Section  V  of  this  Sectoral  Annex  shall  occur  upon 
notice  of  consent  to  the  Joint  Committee  and  the 
Joint Committee's decision to list such body. 

listing  procedures  shall  supersede 

These 
the 
procedures  in  Article  7(c)  of  the  Agreement  in  its 
entirety  and  the time periods  set out  in Article  7(d) 
of the Agreement. 

EC conformity  assessment bodies listed in Section 
V shall have NRTL status in the U.S. 

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SECTION VI (continued^! 

EC 

U.S. 

With  regard  to  the  suspension  of  a  conformity 
assessment  body  listed in this Sectoral  Annex, the 
period  specified  in Article  8(e)  of  the  Agreement 
shall  begin  to  run  after  a  Party  has  notified  the 
Joint  Sectoral  Committee  or the Joint  Committee, 
pursuant  to  Article  8(c) of  the  Agreement,  that  it 
proposes  to  revoke  the  conformity  assessment 
body's 
its 
in  accordance  with 
procedures under its applicable domestic law. 

recognition 

Except as provided  for  in this Section, procedures 
for designation, listing, suspension and withdrawal 
of  conformity  assessment  bodies  under 
this 
Sectoral  Annex shall  be carried  out  in accordance 
with Articles 7, 8 and 9 of the Agreement. 

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SECTION VII 

JOINT SECTORAL COMMITTEE FOR ELECTRICAL SAFETY 

The  Joint  Sectoral  Committee  for  Electrical  Safety  (JCS/ES)  consists  of 
representatives of the U.S. and the EC. ÔSHA shall represent the U.S. on this 
Joint  Sectoral  Committee. The  EC and  OSHA  may  invite  the participation  of 
others as deemed necessary. Each Party shall have one vote and decisions shall 
be  made  by  unanimous  consent,  unless  otherwise  specified  herein.  The  Joint 
Sectoral Committee shall determine its own rules of procedure. 

The Joint  Sectoral  Committee  may address  any  matter  related  to the  effective 
functioning of this Sectoral Annex, including : 

-  Developing  improved  procedures  and  criteria  for  designation  in  order  to 
facilitate  the  assessment  and  preparation  of  proposals  by  Designating 
Authorities, with a view towards expediting the period  between  designation 
and listing; 

-  providing  a  forum  for  discussion  of  issues  that  may  arise  concerning  the 

implementation of this Sectoral Annex; 

-  advising the Parties on matters relating to this Sectoral Annex; and 

-  enhancing the operation of this Sectoral Annex. 

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US - EC  MRA Recreational Craft Annex 

EC - U.S.  MRA 

SECTORAL ANNEX 

FOR 

RECREATIONAL CRAFT 

This  Annex  constitutes  a  Sectoral  Annex  to  the Agreement  on  Mutual  Recognition 
between the Unites States and the European Community. 
The purpose of this Sectoral Annex is to establish a framework to accept  certificates 
of conformity  issued  in the territory  of one  Party  in accordance  with the  regulatory 
requirements of the other Party as referenced in this Sectoral Annex. 
To facilitate that purpose, a transitional period of eighteen months is arranged to build 
confidence as defined in this Sectoral Annex, Section 6. 

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1. 

2. 

1. 

2. 

SECTION 1 
LEGISLATIVE. REGULATORY. AND ADMINISTRATIVE 
REQUIREMENTS 

For the European Community: 
European  Parliament  and  European  Council  Directive  94/25  EEC  on  the 
Approximation of the Laws, Regulations, and Administrative Provisions of the 
Member States Relating to Recreational Craft. 
For the US,: 
46 U.S.C. Chapter 43, 33 CFR 81, 84, 159, 179, 181,183 and 46 CFR 58. 

SECTION 2 
SCOPE AND COVERAGE 

This  Sectoral  Annex  applies  to  all  recreational  craft  which  in  the  European 
Community  or  the  United  States  are  subject  to  conformity  assessment  by a 
conformity  assessment  body  or an  approval  procedure, as  applicable,  before 
being put on the market. 

The  product  coverage  for  each  Party  shall  be  determined  by  the  following 
relevant requirements: 

(a) 

for the European Community: 

Recreational craft as defined in Directive 94/25 EEC. 

(b) 

for the United States: 
Any product falling under the scope of 46  U.S.C. Chapter 43,  33 CFR 
81, 84, 159, 179, 181, 183 and 46 CFR 58. 

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The  Parties  agree  that  for  mutual  recognition  to  operate  under  this  Sectoral 
Annex, the following arrangements shall apply: 

(a) 

(b) 

for  approvals  to  European  Community  requirements,  conformity 
assessment bodies designated by the U.S. shall establish compliance as 
required  to  be  demonstrated  by  Directive  94/25  EEC. 
This 
demonstration  of  compliance  shall  be  recognized  in  the  European 
Community and products so certified  shall have unrestricted  access to 
the EC market for sale as recreational craft, pursuant to Section 1. 

for  approvals  to  United  States  requirements,  conformity  assessment 
bodies  designated  by  the  European  Community  shall  establish 
compliance  as required  to  be  demonstrated  as  set  forth  in  paragraph 
2(b)  of  this  Section  and products  so  certified  shall  have  unrestricted 
access  to  the  U.S.  market  for  sale  as  recreational  craft,  pursuant  to 
Section 1. 

SECTION 3 
AUTHORITIES RESPONSIBLE FOR DESIGNATING 
THE CONFORMITY ASSESSMENT BODIES 

1. 

For the European Community: 

Member  States  Administrations  as  indicated  in  the  Directive  94/25  EEC, 
Article 9.1. 

2. 

For the United States: 

National Institute of Standards and Technology (NI ST). 

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SECTION 4 
DESIGNATING. LISTING. SUSPENDING AND WITHDRAWING 
CONFORMITY ASSESSMENT BODIES 

1. 

For the purpose of this Sectoral  Annex, each party shall designate  competent 
conformity  assessment  bodies  to  carry  out  conformity  assessment  and 
approval  to  the  requirements  of  the  other  Party.  Such  designation  shall  be 
carried out according to the procedures set out in Article 7 of the Agreement. 
A  list  of  conformity  assessment  bodies  together  with  the  products  and 
procedures for which they have been listed, is in Section 5 below. 

2. 

Each  Party agrees that the listed  conformity  assessment  bodies  comply  with 
the requirements for such bodies established by the other Party.  These are: 

(a) 

(b) 

for  the  European  Community,  bodies  which  are  Notified  Bodies  in 
accordance with Directive 94/25 EEC, are deemed to be in compliance 
with U.S. requirements; 

for  the  U.S.,  in  accordance  with  the  requirements  set  out  in  the 
regulations listed in Section  1, the conformity  assessment bodies listed 
in Section  5 are designated  by NIST using  the evaluation  procedures 
contained  in  the  appropriate  EN  45000  series  of  standards  or  the 
corresponding ISO/IEC Guides. 

3.  With  regard  to  the  designation,  listing,  suspension  and  withdrawal  of 
conformity  assessment  bodies  under  this  Sectoral  Annex,  the  specific 
procedures in Articles 7, 8 and 9 of the Agreement shall be followed. 

SECTIONS 
CONFORMITY ASSESSMENT BODIES 

European Community 
The conformity assessment bodies designated by the European Community are 
those Notified  Bodies which have been notified  by the Member States of the 
Community, in accordance with Directive 94/25 EEC, and whose  names and 
reference numbers have been published in the Official  Journal of the European 
Communities. 

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2. 

United  States 
[To be provided by U.S.] 

1. 

2. 

SECTION 6 
TRANSITIONAL  ARRANGEMENT 

There shall be a transitional  period of  18 months prior to the operations of this 
Sectoral Annex. 

The purpose of the transitional  arrangement  is to provide a means whereby  the 
Parties  to  this  Agreement  can  cooperate  to  establish  a  system  for  designating 
conformity  assessment  bodies  and  can  mutually  build  confidence  in  the 
this 
abilities  of 
transitional 
arrangement 
that  conformity 
assessment  bodies  comply  with  the  applicable  criteria  and  to  have  the 
equipment  approved  by  the  conformity  assessment  bodies  of  the  exporting 
country accepted by the approval authority of the importing country 

Successful  completion  of 
in  a  determination 

these  bodies. 
is  intended 

to  result 

3. 

During this transitional period, the parties shall: 

(a) 

exchange  information  on  technical  data  and  conformity  assessment 
criteria  and  procedures,  thus  developing  greater  familiarity  with  their 
respective regulatory requirements; and 

(b) 

carry  out  or  recommend  any  applicable  policy, 
regulatory changes necessary  for the provisions of this Annex. 

legislative  and 

Product  Scope 
All products covered by Section 2 of this Annex. 

Cooperation 
During  this  transitional  period,  both  Parties  shall  endeavor  to jointly  sponsor 
seminars  for  the  purpose  of  improving  the  understanding  of  technical 
specifications  applicable in each Party's jurisdiction. 

Inspections 
Inspections  or  audits  shall  be  permitted  to  verify  compliance  of  conformity 
assessment  bodies with their responsibilities  under this Agreement.  The scope 
of these inspections or audits shall be agreed upon in advance by both Parties. 

4. 

5. 

6. 

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SECTION 7 
ADDITIONAL PROVISIONS 

1. 

2. 

In accordance with the relevant provisions of the Agreement, the Parties shall 
ensure  the  continued  availability  of  the  names  of  their  respective  notified 
bodies or conformity  assessment  bodies, and shall regularly  supply  details of 
certifications issued in order to facilitate post market surveillance. 

The  Parties  note  that, to  the extent  that  requirements  for  electrical  safety  or 
electromagnetic compatibility  may apply to products covered  by this Sectoral 
Annex,  the  provisions  of  the  Sectoral  Annexes  on  Electrical  Safety  and 
Electromagnetic Compatibility apply. 

SECTION 8 
DEFINITIONS 

Notified  Body means a third party  authorized  to perform  the conformity  assessment 
tasks specified  in Directive 94/25 EEC, which has been appointed by a Member State 
from  the bodies falling  within  its jurisdiction.  The Notified  Body has the necessary 
qualifications  to meet requirements  laid down in Directive  94/25  EEC and  has been 
notified  to the Commission and to the other Member States. 

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EC-U.S. MRA 

SECTORAL ANNEX 

FOR 

PHARMACEUTICAL GOOD MANUFACTURING  PRACTICES 

(GMPs) 

PREAMBLE 

Recognizing  that  this  Annex  constitutes  a  Sectoral  Annex  to  the framework 
Agreement  on  Mutual  Recognition  between  the  United  States  and  the  European 
Community. 

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CHAPTER 1 
DEFINITIONS, PURPOSE, SCOPE AND COVERAGE 

Article 1 
Definitions 
1. "Equivalence " of the regulatory systems means that the systems are  sufficiently 
comparable to assure that the process of inspection  and the ensuing  inspection 
reports  will  provide  adequate  information  to  determine  whether  respective 
statutory  and  regulatory  requirements  of  the  authorities  have  been  fulfilled. 
"Equivalence" does  not  require  that  the  respective  regulatory  systems  have 
identical procedures. 

2.  "Enforcement"  means action  taken  by  an  authority  to  protect  the  public  from 
products  of  suspect  quality,  safety  and  efficacy  or  to  assure  that  products  are 
manufactured  in compliance  with  appropriate  laws,  regulations,  standards and 
commitments made as part of the approval to market a product. 

3.  "Good Manufacturing Practices " ^tentative merging of US and EC concepts to 

be revisited) 
GMPs mean the requirements  found  in the respective  legislations, regulations, 
and  administrative  provisions  for  methods  to  be  used  in,  and  the  facilities  or 
controls to be used for,  the manufacturing,  processing, packing, and/or holding 
of a drug to assure that such drug meets the requirements as to safety,  and' has 
the identity and strength, and meets the quality and purity characteristics that it 
purports or is represented to process. 
GMPs  are  that  part  of  quality  assurance  which  ensures  that  products  are 
consistently  produced  and  controlled  to quality  standards.  For  the  purpose  of 
this  Annex,  GMPs  include  therefore  the  system  whereby  the  manufacturer 
receives  the  specifications  of  the  product  and/or  process from the  Marketing 
Authorization/Product Authorization or License holder or applicant and ensures 
the  product  is  made  in  compliance  with  its  specifications  (Qualified  Person 
certification  in the EC). 

4.  "Inspection"  means  an  on-site  evaluation  of  a  manufacturing  facility  to 
determine whether such manufacturing  facility  is operating  in compliance with 
Good Manufacturing  Practices and/or commitments made as part of the approval 
to market a product. 

5.  "Inspection  Report" means  the  written  observations  and  Good  Manufacturing 
in 

Practices  compliance  assessment  completed  by  an  authority 
Appendix 2. 

listed 

6.  "Regulatory  System"  means  the  body  of  legal  requirements  for  Good 
Manufacturing Practices, inspections, and enforcements that ensure public health 
protection and legal authority to assure adherence to these requirements. 

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Article 2 
Purpose 
The provisions of this Annex govern the exchange between the Parties and normal 
endorsement  by the receiving  authority  of official  Good  Manufacturing  Practices 
(GMP) inspection reports after  a transitional  period aimed at determination  of the 
equivalence  of the regulatory  systems of the  Parties, which  is  the  cornerstone  of 
this Annex. 

Article 3 
Scope 
The provisions of this Annex shall apply to pharmaceutical  inspections carried out 
in  the  United  States  and  Member  States  of  the  European  Community  before 
products are marketed (hereafter  referred  to as "pre-approval inspections") as well 
as during their marketing (hereafter referred to as "post-approval inspections"). 
Appendix  1 names the  laws, regulations  and  administrative  provisions  governing 
these inspections and the GMP requirements. 
Appendix 2 lists the authorities participating in activities under this Annex. 
Articles 6, 7, 8, 9, 10 and 11  of the Agreement do not apply to this Annex. 

Article 4 
Product coverage 
These  provisions  will  apply  to  medicinal  products  for  human  or  animal  use, 
intermediates  and  starting  materials  (as  referred  to  in  the  EU)  and  to  drugs  for 
human or animal use, biological products for human use, and active pharmaceutical 
ingredients  (as  referred  to  in  the  United  States),  only  to  the  extent  they  are 
regulated by the authorities of both Parties as listed in Appendix 2. 

Human  blood,  human  plasma,  human  tissues  and  organs,  and  veterinary 
immunologicals  are  excluded  from  the  scope  of  this  Annex.  Human  plasma 
derivatives  (such  as  immunoglobulins  and  albumin),  investigational  medicinal 
products/new  drugs,  human  radiopharmaceuticals  and  medicinal  gases  are  also 
excluded during the transition phase, their situation will be reconsidered at the end 
of the transition period. Products regulated by the Center for Biologies Evaluation 
and Research as devices are not covered under this Annex. 
Appendix 3 contains an indicative list of products covered by this Annex. 

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CHAPTER 2 

TRANSITION PERIOD 

Article 5 
Length of transition period 

A three-year  transition  period  will  start  immediately  after  the  effective  date  of  the 
Agreement. 

Article 6 
Equivalence assessment 

1.  The  criteria  to  be  used  by  the  Parties  to  assess  equivalence  are  listed  in 
the  criteria  under  Community 

Appendix  4.  Information  pertaining 
competence will be provided  by the Community. 

to 

2.  The authorities of the parties will establish  and communicate  to each other  their 
draft  programs  for  assessing  the  equivalence  of  the  respective  regulatory 
systems  in terms of quality  assurance of the products  and  consumer  protection. 
These programs will be carried  out, as deemed  necessary  by the authorities,  for 
post- and pre-approval inspections and for various product classes or processes. 

3.  The  equivalence  assessment  shall  include  information  exchanges  (including 
inspection  reports),  joint  training,  and  joint  inspections  for  the  purpose  of 
assessing  regulatory  systems  and the authorities'  capabilities.  In conducting  the 
equivalence  assessment,  the  Parties  will  ensure  that  efforts  are  made  to  save 
resources. 

4.  Equivalence  assessment  for  authorities  added  to  Appendix  2  after  the  effective 
date of this agreement  will be conducted  as described  in this Annex, as  soon  as 
practicable. 

Article 7 
Participation in the equivalence assessment and determination 

The authorities  listed  in  Appendix  2  will  actively  participate  in  these  programs  to 
build a sufficient  body of evidence for their equivalence determination. Both parties 
will  exercise  good 
to  complete  equivalence  assessment  as 
expeditiously  as possible to the extent the resources of the authorities allow. 

faith  efforts 

Article 8 
Other transition activities 

As soon as possible, the authorities  will jointly determine  the essential  information 
which must be present  in inspection reports and will cooperate to develop  mutually 
agreed  inspection report  format(s). 

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CHAPTER 3 
END OF TRANSITION PERIOD 

Article 9 
Equivalence determination 
Equivalence  is  established  by  having  in  place  regulatory  systems  covering  the 
criteria  referred  to  in  Appendix  4,  and  a  demonstrated  pattern  of  consistent 
performance  in accordance  with these criteria. A list  of authorities  determined  as 
equivalent  shall  be  agreed  to  by  the Joint  Sectoral  Committee  at  the  end  of  the 
transition period, with reference  to any limitation  in terms of inspection type (e.g. 
post-approval or pre-approval) or product classes or processes. 
The Parties will document insufficient  evidence of equivalence, lack of opportunity 
to assess equivalence or a determination of non-equivalence, in sufficient  detail to 
allow the authority being assessed to know how to attain equivalence. 

Article 10 

Authorities not listed as currently equivalent 
Authorities not currently listed as equivalent, or not equivalent for certain types of 
inspections,  product  classes  or  processes  may  apply  for  reconsideration  of  their 
status  once  the  necessary  corrective  measures  have  been  taken  or  additional 
experience is gained. 

CHAPTER 4 

OPERATIONAL PERIOD 

Article 11 
Start of the operational period 
The  operational  period  shall  start  at  the  end  of  the  transition  period  and  its 
provisions apply to inspection reports generated by authorities listed as equivalent 
for the inspections performed  in their territory. 
In  addition,  when  an  authority  is  not  listed  as  equivalent  based  on  adequate 
experience  gained  during  the  transition  period,  the  FDA  will  accept  for  normal 
endorsement (as provided  in Article  12) inspection reports generated as a result of 
inspections conducted jointly by that authority on its territory and another authority 
listed as equivalent, provided that the authority  of the Member State in which the 
inspection is performed  can guarantee enforcement of the findings of the inspection 
report and require that corrective measures be taken when necessary. FDA has the 
option  to participate  in these  inspections, and  based  on experience  gained  during 
the transition period, the Parties will agree on procedures for exercising this option. 

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In  the  EC, the  qualified  person  will  be  relieved  of  responsibility  for  carrying  the 
controls  laid  down  in  Article  22 paragraph  1(b) of  Council  Directive  75/319/EEC 
provided that these controls have been carried out in the United  States and that each 
batch/lot  is  accompanied  by  a  batch  certificate  (in  accordance  with  the  WHO 
certification  scheme  on  the  quality  of  medicinal  products) 
the 
manufacturer  certifying  that  the  product  complies  with  requirements  of  the 
marketing  authorization  and  signed  by  the  person  responsible  for  releasing  the 
batch/lot. 

issued  by 

Article 12 
Nature of recognition of inspection reports 

Inspection  reports  (containing 
information  as  established  under  Article  8), 
including  a  GMP  compliance  assessment,  prepared  by  authorities  listed  as 
equivalent,  will  be provided  to the  authority  of  the  importing  Party.  Based  on  the 
determination  of  equivalence  in  light  of  the  experience  gained,  these  inspection 
reports  will  normally  be  endorsed  by  the  authority  of  the  importing  Party,  except 
under  specific  and  delineated  circumstances.  Examples  of  such  circumstances 
include  indications  of  material  inconsistencies  or  inadequacies  in  an  inspection 
report,  quality  defects  identified  in  the  post-market  surveillance  or  other  specific 
evidence  of  serious  concern  in  relation  to  product  quality  or.consumer  safety.  In 
such  cases, the authority  of the  importing  Party  may  request  clarification  from  the 
authority  of the exporting  Party which may  lead to a request  for  re-inspection.  The 
authorities will endeavor to respond to requests for clarification  in a timely  manner. 

Where  divergence  is  not  clarified  in  this  process,  an  authority  of  the  importing 
country may carry out an inspection of the production  facility. 

Article 13 

Transmission of post-approval  inspection reports 

Post-approval  GMP  inspection  reports  concerning  products  covered  by  this  Annex 
will  be  transmitted  to  the  authority  of  the  importing  country  within  60  calendar 
days  of  the  request.  Should  a new  inspection  be  needed,  the  inspection  report  will 
be transmitted 90 calendar days of the request. 

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Article 14 
Transmission ofpre-approval  inspection reports 

A preliminary  notification  that an  inspection  may  have  to  take  place will  be  made 
as soon as possible. 
Within  15  calendar  days,  the  relevant  authority  will  acknowledge  receipt  of  the 
request  and  confirm  its ability  to carry  out the  inspection.  In the  EC, requests  will 
be  sent  directly  to the  relevant  authority,  with  a copy  to the  European  Agency  for 
the  Evaluation  of  Medicinal  Products  (EMEA).  If  the  authority  receiving  the 
request  cannot  carry  out the  inspection  as requested,  the requesting  authority  shall 
have the right to conduct the inspection. 

Reports  of  pre-approval  inspections  will  be  sent  within  45  calendar  days  of  the 
request that transmitted  the appropriate  information  and detailed  the precise  issues 
to  be  addressed  during  the  inspection.  A  shorter  time  may  be  necessary  in 
exceptional  cases and these will be described in the request. 

Article 15 
Monitoring continued equivalence 

Monitoring  activities  for  the  purpose  of  maintaining  equivalence  shall  include 
review  of  the  exchange  of  inspection  reports  and  their  quality  and  timeliness; 
performance  of a limited  number  of joint  inspections; and the conduct  of  common 
training sessions. 

Article 16 

Suspension 

Each  Party  has the right to contest  the equivalence  of an  authority.  This  right  will 
be exercised  in an objective and reasoned manner in writing to the other Party. 

The  issue  shall  be  discussed  in  the  Joint  Sectoral  Committee  promptly  upon  such 
notification.  Where the JSC determines that verification  of equivalence  is required, 
it  may  be  carried  out  jointly  by  the  Parties  in  a  timely  manner,  pursuant  to 
Article 6. 

Efforts  will  be made  by the Joint  Sectoral  Committee  to  reach  unanimous  consent 
on  the  appropriate  action.  If  agreement  to  suspend  is reached  in  the  Joint  Sectoral 
Committee, an authority may be suspended  immediately  thereafter.  If no agreement 
is  reached  in  the  Joint  Sectoral  Committee,  the  matter  is  referred  to  the  Joint 
Committee.  If  no  unanimous  consent  is  reached  within  30  days  after  such 
notification,  the contested authority will be suspended. 

Upon  the  suspension  of  an  authority  previously  listed  as  equivalent,  a  Party  is  no 
longer  obligated  to  normally  endorse  the  inspection  reports  of  the  suspended 
authority.  A Party  shall  continue  to normally  endorse the  inspection reports  of that 
authority  prior  to  suspension,  unless  the  authority  of  the  receiving  party  decides 
otherwise  based  on  health  or  safety  considerations.  The  suspension  will  remain  in 
effect  until  unanimous  consent  has been  reached  by the Parties on the  future  status 
of that  authority. 

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CHAPTERS 
JOINT SECTORAL COMMITTEE 

Article 17 
Role and composition of the Joint Sectoral Committee 

A  Joint  Sectoral  Committee  is  set  up  to  monitor  the  activities  under  both  the 
transitional and operational phases of this Annex. 

The  Committee  will  be  co-chaired  by  a  representative  of  FDA  for  the  US  and  a 
representative  of the  EC  who  each  will  have  one  vote. Decisions  will  be  taken  by 
unanimous consent. 

The Joint Sectoral Committee's functions  will include: 

1.  making  a  joint  assessment,  which  must  be  agreed  by  both  Parties,  of  the 

equivalence of the respective authorities, 

2.  developing  and  maintaining  the  list  of  equivalent  authorities,  including  any 
limitation in terms of inspecting type or products, and communicating  the list to 
all authorities and the Joint Committee, 

3.  providing  a  forum  to  discuss  issues  relating  to  this  Annex,  including  concerns 
that an authority may be no longer equivalent and opportunity to review product 
coverage, 

4.  consideration  of the issue of suspension. 

The  Joint  Sectoral  Committee  shall  meet  at the  request  of  either  Party  and,  unless 
the co-chairs otherwise  agree, at least once each year. The Joint  Committee  will  be 
kept  informed  of  the  agenda  and  conclusions  of  meetings  of  the  Joint  Sectoral 
Committee. 

CHAPTER 6 
INFORMATION EXCHANGE 

Article 18 
Regulatory collaboration 

The  Parties  and  authorities  shall  inform  and  consult  one  another,  as  permitted  by 
law,  on  proposals  to  introduce  new  controls  or  to  change  existing  technical 
regulations or inspection  procedures and to provide the opportunity  to comment  on 
such proposals. 

The Parties shall notify  each other in writing of any changes to Appendix 2. 

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Articled 

Information relating to quality aspects 
The authorities will establish  an appropriate  means of exchanging  information  on 
any  confirmed  problem  reports,  corrective  actions,  recalls,  rejected  import 
consignments and other regulatory and enforcement  problems for products subject 
to this Annex. 

Article 20 
Alert System 

The details of an alert system will be developed during the transitional period. The 
system  will  be  maintained  in  place  at  all  times.  Elements  to  be  considered  in 
developing such a system are described in Appendix 5. 
Contact points will be agreed between both Parties to permit authorities to be made 
aware with the appropriate  speed  in case of quality  defect,  recalls,  counterfeiting 
and other problems concerning quality, which could necessitate additional controls 
or suspension of the distribution of the product. 

CHAPTER 7 

SAFEGUARD CLAUSE 

Article 21 
Each  Party  recognizes  that  the  importing  country  has  a right to  fulfill  its  legal 
responsibilities by taking actions necessary to ensure the protection  of human and 
animal  health  at  the  level  of  protection  it  deems  appropriate.  This  includes  the 
suspension  of  the  distribution,  product  detention  at  the  border  of  the  importing 
country,  withdrawal  of the  batches  and  any  request  for  additional  information  or 
inspection as provided in Article 12. 

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APPENDIX  1 

List of applicable laws, regulations and administrative provisions 

For the European Community: 
Council  Directive  65/65/EEC  of  26  January  1965  on  the  approximation  of 
provisions  laid  down  by  law,  regulation  or  administrative  action  relating  to 
proprietary medicinal products as extended, widened and amended. 
Council Directive 75/319/EEC of 20 May  1975 on the approximation of provisions 
laid  down  by  law,  regulation  or  administrative  action  relating  to  proprietary 
medicinal products as extended, widened and amended. 
Council  Directive  81/851/EEC of 6 November  1981 on the approximation  of the 
laws of the Member States relating to veterinary medicinal products as widened and 
amended. 
Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and 
guidelines of good manufacturing practice for medicinal products for human use 
Commission Directive 91/412/EEC of 23 July  1991 laying down the principles and 
guidelines of good manufacturing practice for veterinary medicinal products 
Council  Regulation No (EEC) 2309/93 of 23 July  1993 laying  down  Community 
procedures  for the authorization  and supervision  of medicinal products  for human 
and  veterinary  use  and  establishing  a  European  Agency  for  the  Evaluation  of 
Medicinal Products 
Council  Directive 25/92/EEC of 31 March  1992 on the wholesale  distribution  of 
medicinal products for human use & Guide to Good Distribution Practice 
Current  version  of  the  Guide  to  Good  Manufacturing  Practice,  Rules  Governing 
Medicinal Products in the European Community, Volume IV. 

For the United States : 
Relevant sections of the United States Federal Food, Drug, and Cosmetic Act and 
the United States Public Health Service Act 
Relevant  sections  of  Title  21, United  States  Code  of  Federal  Regulations  (CFR) 
Parts 1-99, Parts 200-299, Parts 500-599, and Parts 600-799 
Relevant  sections  of  the  FDA  Investigations  Operations  Manual,  the  FDA 
Regulatory Procedures Manual, the FDA Compliance Policy Guidance Manual, the 
FDA Compliance Program Guidance Manual, and other FDA guidances. 

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APPENDIX 2 
list  of Authorities 

United  States 
In the United  States, the regulatory authority  is the Food and Drug  Administration. 

European  Community 
In the European Community, the regulatory authorities are the  following: 

Austria: 

Belgium: 

Denmark: 

Finland: 

France: 

Germany: 

Greece: 

Ireland: 

Italy: 

Bundesministerium fur Arbeit, Gesundheit und Soziales, Wien 

Ministerie van Sociale Zaken, Volksgezondheid  en 
Leefmilieu/Ministère  des Affaires  Sociales, Santé Publique et 
Environnement/Algemene Farmaceutische  Inspectie, Inspection 
Générale de la Pharmacie, Brussel, Bruxelles 

Lasgemiddelstyrelsen, Danish  Medicines Agency, Bronshoj 

Lââkelaitos/Lâkemedelsverket (National  Agency for  Medicines), 
Helsinki 

Agence du Médicament, Direction de l'inspection  et des 
établissements, Saint Denis (Human) 
Agence Nationale du Médicament Vétérinaire, Fougères  (Veterinary) 

Bundesgesundheitsministerium,  Bonn 
Paul-Ehrlich Institut, Langen (biologicals only) 
Zustandige Behôrden der  16 Bundeslânder: Bayern, Berlin, 
Brandenburg, Bremen, Hamburg, Hessen, Niedersachsen,  Nordrhein-
Westfalen,  Rheinland-Pfalz,  Mecklenburg-Vorpommern,  Saarland, 
Sachsen, Sachsenanhalt,  Schleswig-Holstein, Thuringen 

Ministry of Health and Welfare, National  Drug Organisation  (E.O.F.), 
Athens 

Irish  Medicines Board, Dublin 

Ministero délia Sanità, Dipartimento Farmaci e  Farmacovigilanza, 
Roma - (Human) 
Ministero délia Sanità, Dipartimento alimenti e nutrizione e sanità 
pubblica veterinaria - Div. IX, Roma - (Veterinary) 

Luxembourg: 

Direction  de la Santé, Division de la Pharmacie et des Médicaments, 
Luxembourg 

The Netherlands:  Staatstoezicht op de Volksgezondheid,  Inspectie voor de 

Gezondheidszorg,  Rijswijk 

Portugal: 

Spain: 

Instituto da Farmàcia e do Medicamento (INFARMED),  Lisboa 

Ministerio Sanidad y Consumo, Subdirecciôn. General  de Control 
Farmacéutico, Madrid  (Human) 
Ministerio de Agricultura  Pesca y Alimentaciôn, Madrid,  (Veterinary) 

Sweden: 

Lâkemedelsverket ( Medical  Products Agency), Uppsala 

United  Kingdom:  Medicines Control  Agency, London 

Veterinary  Medicines Directorate,  Addlestone 

European  Union:  European  Commission,  Brussels 

European  Agency  for the  Evaluation  of Medicinal  Products (EMEA) 

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APPENDIX 3 

Indicative list of Products covered by the Sectoral Annex 

Recognizing that precise definition of medicinal products and drugs are to be found 
in the legislations  referred  to above, an indicative  list of products covered  by the 
agreement is given below: 
-  human medicinal products including prescription and non-prescription drugs; 
-  human biologicals including vaccines, and immunologicals; 
-  veterinary  pharmaceuticals,  including  prescription  and  non-prescription  drugs, 

with the exclusion of veterinary immunologicals; 

-  pre-mixes  for  the  preparation  of  veterinary  medicated 

feeds  (EC),  Type  A 

- 

medicated articles for the preparation of veterinary medicated feeds (US); 
intermediate  products  and  active  pharmaceutical 
pharmaceuticals (US) / starting materials (EC). 

ingredients  or  bulk 

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APPENDIX 4 

Criteria for Assessing Equivalence for Post- and Pre-Approval 

I. 

Legal / Regulatory authority and structures and procedures providing for post-
and pre-approval: 

A.  Appropriate statutory mandate and jurisdiction. 
B.  Ability to issue and update binding requirements on GMPs and guidance 

documents. 

C.  Authority  to make  inspections,  review  and  copy  documents, and  to take 

samples and collect other evidence. 

D.  Ability to enforce requirements and to remove products found  in violation 

of such requirements from the market. 

E.  Substantive current good manufacturing requirements 
F.  Accountability of the regulatory authority. 
G.  Inventory of current products and manufacturers. 
H.  System for maintaining or accessing inspection reports, samples and other 
analytical  data,  and  other  firm/product  information  relating  to  matters 
covered by this Sectoral Annex. 

II.  Mechanisms in place to assure appropriate professional  standards and 

avoidance of conflicts of interest. 

III.  Administration of the regulatory authority: 

A.  Standards of education/qualification and training. 
B.  Effective  quality  assurance  systems  measures  to  ensure  adequate  job 

performance. 

C.  Appropriate staffing  and resources to enforce laws and regulations. 

IV.  Conduct of Inspections: 

A.  Adequate  preinspection  preparation,  including  appropriate  expertise  of 
investigator / team, review of firm / product and databases, and availability 
of appropriate inspection equipment. 

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B.  Adequate conduct  of  inspection,  including  statutory  access  to  facilities, 
effective  response  to  refusals,  depth  and  competence  of  evaluation  of 
operations,  systems,  and  documentation;  collection  of  evidence; 
appropriate  duration  of  inspection  and  completeness  of  written  report  of 
observations to firm management. 

C.  Adequate post-inspection activities, including completeness of inspectors' 
report, inspection report review where appropriate, and conduct of follow-
up  inspections  and  other  activities  where  appropriate,  assurance  of 
preservation and retrieval of records. 

V.  Execution of regulatory  enforcement  actions to achieve corrections, designed 
to  prevent  future  violations,  and  to  remove  products  found  in  violation  of 
requirements from the market. 

VI.  Effective  Use of Surveillance Systems: 

A.  Sampling and analysis 
B.  Recall monitoring 
C.  Product defect reporting system 
D.  Routine surveillance inspections 
E.  Verification  of  approved  manufacturing  process  changes  to  marketing 

authorizations / approved applications 

VII. Additional specific criteria for pre-approval inspections 

A.  Satisfactory  demonstration  through  a jointly  developed  and  administered 
inspections  to  assess  the  authorities' 

training  program  and  joint 
capabilities. 

B.  Pre-inspection  preparation  includes  the  review  of  appropriate  records, 
including  site  plans  and  drug  master  file  or  similar  documentation  to 
enable adequate inspections. 

C.  Ability to verify  chemistry, manufacturing  and control data supporting an 

application is authentic and complete. 

D.  Ability  to  assess  and  evaluate  research  and  development  data  as 
scientifically  sound, especially  transfer  technology  of pilot,  scale  up and 
full scale production batches. 

E.  Ability to verify  conformity  of the on site processes and procedures with 

those described in the application. 

F.  Review and evaluate equipment  installation, operational  and  performance 

qualification data, and evaluate test method validation. 

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APPENDIX  5 

Elements to be Considered  in Developing a Two-wav Alert System 

1.  Documentation 

-  Definition  of  a  crisis/emergency  and  under  what  circumstances  an  alert  is 

required 

-  Standard Operating Procedures (SOPs) 

-  Mechanism of health hazards evaluation and  classification 

-  Language of communication  and transmission of  information 

2.  Crisis Management  System 

-  Crisis analysis and communication  mechanisms 

-  Establishment of contact points 

-  Reporting mechanisms 

«. 

3.  Enforcement  Procedures 

-  Follow-up mechanisms 

-  Corrective action procedures 

4.  Quality Assurance  System 

-  Pharmacovigilance  programme 

-  Surveillance/monitoring of implementation  of corrective action 

5.  Contact points 

For the purpose of this agreement, the contact points for the alert system will be: 
for  the European Community, 

the Executive Director of the European Agency  for the Evaluation of 
Medicinal  Products,  7,  Westferry  Circus,  Canary  Wharf,  UK  -
London  El4  4HB, England. Telephone  +44-171-418  8400, Fax 418 
8416. 

for  the  United States: 

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EU - U.S. MRA 

SECTORAL ANNEX ON 

MEDICAL DEVICES 

PREAMBLE 

Recognizing that this Annex constitutes a Sectoral Annex to the Agreement on Mutual 
Recognition in Relation to Conformity Assessment (Agreement) between the United 
States (U.S.) and the European Community (EC), 

Acknowledging that carrying out the provisions of this Annex will further public 
health protection, will be an important means of facilitating commerce in medical 
devices, and will lead to reduced costs for regulators and manufacturers of both 
Parties, 

The Parties agree as follows: 

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CHAPTER 1 
PURPOSE, SCOPE AND COVERAGE OF THE SECTORAL  ANNEX 

Article 1 
Purpose 

1.  The  purpose  of  this  Annex  is  to  specify  the  conditions  under  which  a  Party  will 
accept  the  results  of  quality  system-related  evaluations  and  inspections  and 
premarket  evaluations  of  the  other  Party  with  regard  to  medical  devices  as 
conducted  by listed conformity  assessment  bodies (CABs) and to provide  for  other 
related cooperative activities. 

2.  This  Annex  is  intended  to  evolve  as  programs  and  policies  of  the  Parties  evolve. 
The  Parties  will  review  this  Annex  periodically,  in  order  to  assess  progress  and 
identify  potential enhancements to this Annex as FDA and EC policies evolve over 
time. 

Article 2 
Scope 

1.  The  provisions  of  this  Annex  shall  apply  to the  exchange  and,  where  appropriate, 
endorsement  of  the  following  types  of  reports  from  CABs  assessed  to  be 
equivalent: 

a.  Under the U.S. system, surveillance/post-market  and initial/pre-approval  inspection 

reports; 

b.  Under the U.S. system, premarket (510(k)) product evaluation reports; 

c.  Under the EC system, quality system evaluation reports; and 

d.  Under the EC system, EC type examination  and verification  reports. 

Appendix  1  names the legislation, regulations, and related  procedures under which: 
(a)  products  are  regulated  as  medical  devices  by  each  Party;  (b)  CABs  are 
designated and confirmed;  and (c) these reports are prepared. 

2.  For purposes  of this Annex, equivalence  means that:  CABs  in the  EC are  capable 
of  conducting  product  and  quality  systems  evaluations  against  U.S.  regulatory 
requirements  in a manner equivalent  to those conducted  by FDA; and  CABs  in the 
U.S. are capable of conducting  product  and quality  systems evaluations  against  EC 
regulatory  requirements in a manner equivalent to those conducted by EC CABs. 

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Article 3 
Product Coverage 

There are three components to this agreement each covering a discrete range of 
products: 

1. Quality  System  Evaluations  - U.S.-type  surveillance/post-market  and initial/pre-approval 
inspection  reports and EC-type quality  system evaluation  reports will be exchanged  with 
regard to all products regulated under both U.S. and EC law as medical devices. 

2.  Product  Evaluation  -  U.S.-type  premarket  (510(k))  product  evaluation  reports  and  EC-
type-testing reports will be exchanged only with regard to those products classified  under 
the U.S. system as Class I/CIass II - Tier 2 medical devices which are listed in Appendix 2. 

3.  Post-Market  Vigilance  Reports  -  Post-market  vigilance  reports  will  be  exchanged  with 

regard to all products regulated under both U.S. and EC law as medical devices. 

Additional products and procedures may be made subject to this Annex by agreement 
of the Parties.  > 

Article 4 
Regulatory A uthorities 

The regulatory authorities shall have the responsibility of implementing the provisions 
of  this  Annex,  including  the  designation  and  monitoring  of  CABs.  Regulatory 
authorities  are  specified  in  Appendix  3.  Each  Party  will  promptly  notify  the  other 
Party in writing of any change in the regulatory authority for a country. 

CHAPTER 2 
TRANSITION PERIOD 

Article 5 

Length and purpose of transition period 

There will  be a three-year  transition  period  immediately  following  the date of entry 
into force  of the Agreement.  During the transition period, the Parties will engage in 
confidence-building  activities for the purpose of obtaining sufficient  evidence to make 
determinations concerning the equivalence of CABs of the other Party with respect to 
the  ability  to  perform  quality  system  and  product  evaluations  or  other  reviews 
resulting in reports to be exchanged under this Annex. 

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Article 6 
Listing of CABs 

Each  Party  shall  designate  CABs to participate  in confidence-building  activities by 
transmitting  to the  other  Party  a  list  of  CABs which  meet  the  criteria  for  technical 
competence  and  independence,  as  identified  in  Appendix  1.  The  list  shall  be 
accompanied by supporting evidence. Designated  CABs will be listed  in Appendix 4 
for participation in the confidence building activities once confirmed  by the importing 
Party. Non-confirmation  would have to be justified based on documented evidence. 

Article 7 
Confidence Building Activities 

1. At the beginning of the transitional period, the Joint Sectoral Group will establish a 
joint confidence  building program calculated to provide sufficient  evidence of the 
capabilities  of  the  designated  CABs  to  perform  quality  system  or  product 
evaluations to the specifications of the Parties. 

2.  The joint  confidence  building  program  should  include  the  following  actions  and 

activities: 

a.  Seminars designed to inform  the Parties and CABs about each Party ' s regulatory 

system, procedures, and requirements; 

b.  Workshops  designed 

to  provide 

the  Parties  with 

information 

regarding 

requirements and procedures for the designation and surveillance of CABs; 

c.  Exchange of information about reports prepared during the transition period; 

d.  Joint training exercises; and 

e.  Observed inspections. 

3.  During the transition period, any significant  problem that is identified  with a CAB 
may be the subject of cooperative activities, as resources allow and as agreed to by 
the regulatory authorities, aimed at resolving the problem. 

4.  Both  Parties  will  exercise  good  faith  efforts  to complete  the confidence  building 
activities as expeditiously as possible to the extent that the resources of the Parties 
allow. 

5.  Both  the  EC and  the  U.S. will  each  prepare  annual  progress  reports  which  will 
describe  the  confidence  building  activities  undertaken  during  each  year  of  the 
transition  period.  The form  and content  of the reports will  be determined  by the 
Parties through the Joint Sectoral Committee. 

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Article 8 

Other transition period activities 

1.  During the transition period, the Parties will jointly determine the necessary 
information which must be present in quality system and product evaluation 
reports. 

2.  The Parties will jointly develop a notification and alert system to be used in case of 

defects, recalls, and other problems concerning product quality that could 
necessitate additional actions (e.g., inspections by the Parties of the importing 
.country) or suspension of the distribution of the product. 

CHAPTER 3 
END OF TRANSITION PERIOD 

Article 9 
Equivalence Assessment 

1. In the final six months of the transition period, the Parties shall proceed to a joint 
assessment  of  the  equivalence  of  the  CABs  that  participated  in  the  confidence 
building activities. CABs will be determined  to be equivalent  provided  they have 
demonstrated  proficiency  through  the  submission  of  a  sufficient  number  of 
adequate  reports.  CABs  may  be  determined  to  be  equivalent  with  regard  to  the 
ability to perform any type of quality system or product evaluation covered by this 
Annex and with regard to any type of product covered by this Annex. The parties 
shall develop a list contained in Appendix 5 of CABs determined to be equivalent 
which  shall  contain  a  full  explanation  of  the  scope  of  the  equivalency 
determination, including any appropriate limitations, with regard to performing any 
type of quality system or product evaluation. 

2.  The Parties shall allow CABs not listed for participation in the MRA, or listed  for 
participation  only  as to certain  types of evaluations, to apply  for  participation  in 
this  MRA  once the necessary  measures  have been  taken  or  sufficient  experience 
has been gained, in accordance with Article 18. 

3.  Decisions concerning the equivalence of CABs must be agreed to by both Parties. 

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CHAPTER 4 
OPERATIONAL PERIOD 

Article 10 
Start of the operational period 

1. The operational period will start at the end of the transition period after the Parties 
have  developed  the  list  of  CABs  found  to  be  equivalent.  The  provisions  of  this 
Chapter will apply only with regard to listed CABs and only to the extent of any 
specifications and limitations contained on the list with regard to a CAB. 

2.  The operational period will apply to quality system evaluation reports and product 
evaluation reports generated by CABs listed in accordance with this Annex for the 
evaluations  performed  in  the  respective  territories  of  the  Parties,  except  if  the 
Parties agree otherwise. 

Exchange and endorsement of quality system evaluation reports 

Article 11 

1. Listed EC CABs will provide FDA with reports of quality system evaluations, as 

follows: 

a.  For  pre-approval  quality  system  evaluations,  EC  CABs  will  provide  full  répons; 

and 

b.  For  surveillance  quality  system  evaluations,  EC  CABs  will  provide  abbreviated 

reports. 

2.  Listed  U.S.  CABs  will  provide  to  the  EC Notified  Body  of  the  manufacturer's 

choice: 

a.  Full reports of initial quality system evaluations; 

b.  Abbreviated reports of quality systems surveillance audits. 

3.  If the abbreviated reports do not provide sufficient  information, the importing Party 

may request additional clarification  from the CAB. 

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Based  on  the  determination  of  equivalence  in  light  of  the  experience  gained,  the 
quality  system  evaluation  reports  prepared  by  the  CABs  listed  as  equivalent  will 
normally  be endorsed  by the importing  Party, except  under specific  and  delineated 
circumstances.  Examples  of  such  circumstances  include  indications  of  material 
inconsistencies or inadequacies in a report, quality defects  identified  in post-market 
surveillance  or  other  specific  evidence  of  serious  concern  in  relation  to  product 
quality  or  consumer  safety.  In  such  cases,  the  importing  Party  may  request 
clarification from the exporting Party which may lead to a request for  re-inspection. 
The  Parties  will  endeavor  to  respond  to  requests  for  clarification  in  a  timely 
manner.  Where divergence  is not clarified  in this process, the importing  Party may 
carry out the quality system evaluation. 

Article 12 
Exchange and endorsement of product  evaluation reports 

1.  EC  CABs  listed  for  this purpose  will,  subject  to  the  specifications  and  limitations 
on  the  list,  provide  to  the  FDA  510(k)  premarket  notification  assessment  reports 
prepared to U.S. medical device requirements. 

2.  U.S. CABs will, subject  to the specifications  and  limitations on the  list, provide to 
the  EC  notified  body  of  the  manufacturer's  choice,  type  examination  and 
verification  reports prepared to EC medical device requirements. 

3.  Based  on  the  determination  of  equivalence  in  light  of  the  experience  gained,  the 
product evaluation reports prepared by the CABs listed as equivalent  will  normally 
be  endorsed  by  the  importing  Party,  except  under  specific  and  delineated 
circumstances.  Examples  of  such  circumstances  include  indications  of  material 
inconsistencies,  inadequacies,  or  incompleteness  in a product  evaluation  report,  or 
to  product  safety, 
other  specific  evidence  of  serious  concern 
performance,  or  quality.  In  such  cases,  the  importing  Party  may  request 
clarification  from  the  exporting  Party  which  may  lead  to  a  request  for  a  re-
evaluation.  The  parties  will  endeavor  to  respond  to  requests  for  clarification  in  a 
timely manner. Endorsement remains the responsibility  of the importing Party. 

in  relation 

Article 13 
Transmission of quality system evaluation reports 

Quality  system  evaluation  reports covered  by Article  11 concerning products covered 
by this Annex shall be transmitted  to the importing  Party within  60 calendar days of a 
request  by the importing  Party.  Should a new inspection  be requested the time period 
shall  be  extended  by  an  additional  30  calendar  days.  A  Party  may  request  a  new 
If  the  exporting  Party  cannot 
inspection,  for  cause, 
perform  an  inspection  within  a  specified  period  of  time,  the  importing  Party  may 
perform  an inspection on its own. 

identified  to  the  other  Party. 

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Article 14 
Transmission of product  evaluation reports 

Transmission  of product  evaluation  reports will take place according  to the  importing 
Party ' s specified  procedures. 

Article 15 
Monitoring continued equivalence 

Monitoring  activities  will  be  carried  out  in  accordance  with  Article  10  of  the 
Agreement. 

Article 16 
Listing of Additional  CABs 

1.  During  the operational  phase, additional  CABs will  be considered  for  equivalence 
using  the  procedures  and  criteria  described  in  Articles  6,  7,  and  9  of  this  Annex, 
taking  into account  the level of confidence  gained  in the overall  regulatory  system 
of the other Party. 

2.  Once  a  designating  authority  considers  that  such  CABs,  having  undergone  the 
procedures  of  Articles  6,  7,  and  9  of  this  Annex,  may  be  determined  to  be 
equivalent,  it will then designate those bodies on an annual  basis. Such  procedures 
satisfy  the procedures of Article 7(a) and (b) of the Agreement. 

3.  Following  such  annual  designations,  the  procedures  for  confirmation  of  CABs 

under Articles 7(c) and (d) of the Agreement shall apply. 

CHAPTER  5 
JOINT SECTORAL  COMMITTEE 

Article 17 
Role and composition of the Joint Sectoral Committee 

1.  A Joint  Sectoral  Management  Committee  is set  up to  monitor  the  activities  under 

both the transitional  and operational phases of this Annex. 

2.  The Committee  will  be co-chaired  by a representative  of the FDA  for the U.S. and 
a representative of the EC who will each have one vote. Decisions will be taken by 
unanimous consent. 

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3.  The JSC's functions  will include: 

a.  making a joint assessment of the equivalence of CABs; 

b.  developing  and  maintaining  the  list  of  equivalent  CABs,  including  any 
limitation in terms of their scope of activities and communicating  the list to 
all authorities arid the Joint Committee; 

c.  providing  a  forum  to  discuss  issues  relating  to  this  Annex,  including 
concerns  that  a  CAB  may  no  longer  be  equivalent  and  opportunity  to 
review product coverage; and 

d.  consideration of the issue of suspension. 

CHAPTER  6 
HARMONIZATION  AND INFORMATION  EXCHANGE 

Article 18 
Harmonization 

During  both  the  transitional  and  operational  phases  of  this  Agreement,  both  Parties 
intend  to  continue  to  participate  in  the  activities  of  the  Global  Harmonization  Task 
Force  and  utilize  the  results  of  those  activities  to  the  extent  possible.  Such 
participation  involves  developing  and  reviewing  documents  developed  by  the  Global 
Harmonization  Task  Force and jointly  determining  whether  they are applicable  to the 
implementation of this Agreement. 

Article 19 
Regulatory cooperation 

The Parties and authorities  shall  inform  and consult  with one another, as permitted  by 
law, of proposals to introduce new controls or to change existing technical  regulations 
or  inspection  procedures  and  to  provide  the  opportunity  to  comment  on  such 
proposals. 

The Parties shall notify  each other in writing of any changes to Appendix  1. 

79 

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Alert system and exchange of post-market vigilance reports 

Article 20 

1. An  alert  system  will  be  set  up  during  the  transition  period  and  maintained 
thereafter  by which the Parties will notify  each other when there is an immediate 
danger  to  public  health.  Elements  of  such  a  system  will  be  described  in  an 
Appendix to be attached to this Sectoral Annex. As part of that system, each Party 
shall notify  the other Party of any confirmed problem reports, corrective actions, or 
recalls. These reports are regarded as part of ongoing investigations. 

2.  Contact points will be agreed between both Parties to permit authorities to be made 
aware  with  the  appropriate  speed  in  case  of  quality  defect,  batch  recalls, 
counterfeiting  and  other  problems  concerning  quality,  which  could  necessitate 
additional controls or suspension of the distribution of the product. 

80 

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APPENDIX 1 
RELEVANT LEGISLATION, REGULATIONS AND PROCEDURES 

1. For the European Union the following legislation applies to Article 2 paragraph  1 : 

a.  Council  Directive  90/385/EEC  of  20  June  1990  on  active  implantable 
medical devices - OJ No. L 189, 20.7. 1990, p.  17. Conformity  assessment 
procedures. 
* Annex 2 (with the exception of section 4) 
*Annex 4 
*Annex 5 

b.  Council Directive 93/42/EEC of  14 June  1993 on Medical Devices  OJ No. 

L 169,12.7.1993,  p.l. Conformity  assessment procedures. 
* Annex 2 (with the exception of section 4) 
*Annex 3 
*Annex 4 
*Annex 5 
*Annex 6 

2.  For the United States, the following legislation applies to Article 2 paragraph  1 : 

a.  The Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§  321 et seq. 

b.  The Public Health Service Act, 42 U.S.C. §§ 201 et seq. 

c.  Regulations of the United States Food and Drug Administration found at 21 

C.F.R., in particular, Parts 800 to 1299. 

d.  Medical Devices; Third-Party Review of Selected Premarket Notifications; 

Pilot Program, 61 Fed. Reg. 14,789-14,796 (April 3, 1996). 

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APPENDIX 2 
SCOPE OF PRODUCT  COVERAGE 

1.  Initial Coverage of the Transition Period 

Upon entry into force of this Annex,1 products qualifying  for the transitional 
arrangements under this Agreement include: 

a.  All  Class I products requiring  premarket  evaluations  in the  United  States  -

see Table 1. 

b.  Those Class II products listed in Table 2. 

2.  During the Transition Period: 

The Parties will jointly identify  additional product groups, including their related 
accessories, in line with their respective priorities as follows: 

a.  Those for  which  review may be based  primarily  on written  guidance  which 

the Parties will use their best efforts  to prepare expeditiously; and 

b.  Those for  which review may be based  primarily  on  international  standards, 

in order for the Parties to gain the requisite experience. 

The  corresponding  additional  product  lists  will  be  phased  in  on  an  annual  basis. 
The  Parties  may  consult  with  industry  and  other  interested  Parties  in  determining 
which products will be added. 

3.  Commencement  of the Operational  Period: 

a.  At  the  commencement  of 

the  operational  period,  product  coverage  shall 

extend to all Class I/II products covered during the transition  period. 

b.  FDA  will  expand  the  program  to  categories  of  Class  II  devices  as  is 
consistent  with  the  results of the pilot,  and  with  the  FDA's  ability  to  write 
guidance documents  if the device pilot for the third  party review of medical 
devices is successful.  The MRA will cover to the maximum  extent  feasible 
all  Class  II devices  listed  in Table  3 for  which  FDA-accredited  third-party 
review is available in the U.S.. 

4. 

Unless explicitly  included by joint decision of the Parties, this agreement  does 

not cover any U.S. Class II -tier 3 or any Class III product under either system. 

1 It is understood  that the date of entry  into force will  not occur prior to June  1,  1998, unless the  Parties 
decide  otherwise. 

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TABLE 1 

CLASS I PRODUCTS REQUIRING PREMARKET EVALUATIONS 
IN THE UNITED STATES, INCLUDED IN SCOPE OF PRODUCT 
COVERAGE AT BEGINNING OF TRANSITION PERIOD 

TABLE 1: CLASS I PRODUCTS REQUIRING PREMARKET 
EVALUATIONS IN THE UNITED STATES 

ANESTHESIOLOGY PANEL (868) 

Section 
No. 
************ 
* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * ** 
* * * * * * * * * * * * * ** 

Regulation Name 
Product Code - Device Name 

868.1910 

868.5620 

868.5640 

868.5675 

868.5700 

868.6810 

ESOPHAGEAL STETHOSCOPE 
BZW - STETHOSCOPE, ESOPHAGEAL 

. 

BREATHING MOUTHPIECE 
BYP - MOUTHPIECE, BREATHING 

MEDICINAL NONVENTILATORY NEBULIZER 
(ATOMIZER) 
CCQ - NEBULIZER, MEDICINAL, NON 
VENTILATORY (ATOMIZER) 

REBREATHING DEVICE 
BYW - DEVICE, REBREATHING 

NONPOWERED OXYGEN TENT 
FOG - HOOD, OXYGEN, INFANT 
BYL - TENT, OXYGEN 

TRACHEOBRONCHIAL SUCTION CATHETER 
BSY - CATHETERS, SUCTION, 
TRACHEOBRONCHIAL 

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CARDIOVASCULAR PANEL 

Regulation Name 
Product Code - Device Name 

Section 
No. 
************ 
a******************************************************************* 
* * * * * * * * * * * * * ** 
(NONE) 

DENTAL PANEL (872) 

Section 
No. 
************ 
* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * ** 

Regulation Name 
Product Code - Device Name 

* * * * * * * * * * * * * ** 

872.3400 

872.3700 

872.4200 

KARAYA AND SODIUM BORATE WITH OR 
WITHOUT ACACIA DENTURE ADHESIVE 
KOM - ADHESIVE, DENTURE, ACACIA AND 
KARAYA WITH SODIUM BORATE 

DENTAL MERCURY (U.S.P) 
ELY - MERCURY 

DENTAL HANDPIECES AND ACCESSORIES 
EBW - CONTROLLER, FOOD, HANDPIECE AND 
CORD 
EFB - HANDPIECE, AIR-POWERED, DENTAL 
EFA - HANDPIECE, BELT AND/OR GEAR DRIVEN, 
DENTAL 
EGS - HANDPIECE, CONTRA- AND RIGHT-ANGLE 
ATTACHMENT, DENTAL 
EKX - HANDPIECE, DIRECT DRIVE, 
AC-POWERED 
EKY - HANDPIECE, WATER-POWERED 

872.6640 

DENTAL OPERATIVE UNIT 
EIA - UNIT, OPERATIVE DENTAL 

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EAR, NOSE, AND THROAT PANEL (874) 

Section 
No. 
************ 
* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * ** 
* * * * * * * * * * * * * ** 

Regulation Name 
Product Code - Device Name 

874.1070 

874.1500 

874.1800 

874.1925 

874.3300 

874.4100 

874.5300 

874.5550 

874.5840 

SHORT INCREMENT SENSITIVITY INDEX (SISI) 
ADAPTER 
ETR - ADAPTER, SHORT INCREMENT 
SENSITIVITY INDEX (SISI) 

GUSTOMETER 
ETM - GUSTOMETER 

AIR OR WATER CALORIC STIMULATOR 
KHH - STIMULATOR, CALORIC-AIR 
ETP - STIMULATOR, CALORIC-WATER 

TOYNBEE DIAGNOSTIC TUBE 
ETK - TUBE, TOYNBEE DIAGNOSTIC 

HEARING AID 
LRB - FACE PLATE HEARING-AID 
ESD - HEARING-AID, AIR-CONDUCTION 

EPISTAXIS BALLOON 
EMX - BALLOON, EPISTAXIS 

ENT EXAMINATION AND TREATMENT UNIT 
ETF - UNIT, EXAMINING/TREATMENT, ENT 

POWERED NASAL IRRIGATOR 
KMA - IRRIGATOR, POWERED NASAL 

ANTISTAMMERING DEVICE 
KTH - DEVICE, ANTI-STAMMERING 

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GASTROENTEROLOGY - UROLOGY PANEL (876) 

Regulation Name 
Product Code - Device Name 

Section 
No. 
************ 
* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * ** 
* * * * * * * * * * * * * ** 
876.5160 

^  UROLOGICAL CLAMPS FOR MALES 

876.5210 

876.5250 

EXTERNAL USE 

FHA - CLAMP, PENILE 

ENEMA KIT 
FCE - KIT, ENEMA, (FOR CLEANING PURPOSE) 

URINE COLLECTOR AND ACCESSORIES 
FAQ - BAG, URINE COLLECTION, LEG, FOR 

GENERAL HOSPITAL PANEL (880) 

Section 
No. 
************ 
* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * ** 
* * * * * * * * * * * * * ** 

Regulation Name 
Product Code - Device Name 

880.5270 

880.5420 

880.5680 

880.6250 

NEONATAL EYE PAD 
FOK - PAD, NEONATAL EYE 

PRESSURE INFUSOR FOR I.V. BAG 
KZD - INFUSOR, PRESSURE, FOR I.V. BAGS 

PEDIATRIC POSITION HOLDER 
FRP - HOLDER, INFANT POSITION 

PATIENT EXAMINATION GLOVE 
LZB - FINGER COT 
FMC - GLOVE, PATIENT EXAMINATION 
LYY - GLOVE, PATIENT EXAMINATION, LATEX 
LZA - GLOVE, PATIENT EXAMINATION, POLY 
LZC - GLOVE, PATIENT EXAMINATION, 
SPECIALITY 
LYZ - GLOVE, PATIENT EXAMINATION, VINYL 

880.6375 

PATIENT LUBRICANT 
KMJ - LUBRICANT, PATIENT 

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880.6760 

PROTECTIVE RESTRAINT 
BRT - RESTRAINT, PATIENT, CONDUCTIVE 
FMQ - RESTRAINT, PROTECTIVE 

NEUROLOGY PANEL (882) 

Section 
No. 
************ 
* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * ** 
* * * * * * * * * * * * * ** 

Regulation Name 
Product Code - Device Name 

882.1030 

882.1420 

882.4060 

882.4545 

882.4650 

- 

882.4750 

ATAXIAGRAPH 
GWW - ATAXIAGRAPH 

ELECTROENCEPHALOGRAM (EEG) SIGNAL 
SPECTRUM ANALYZER 
GWS - ANALYZER, SPECTRUM, 
ELECTROENCEPHALOGRAM SIGNAL 

VENTRICULAR CANNULA 
HCD - CANNULA, VENTRICULAR 

SHUNT SYSTEM IMPLANTATION INSTRUMENT 
GYK - INSTRUMENT, SHUNT SYSTEM 
IMPLANTATION 

NEUROSURGICAL SUTURE NEEDLE 
HAS - NEEDLE, NEUROSURGICAL SUTURE 

SKULL PUNCH 
GXJ - PUNCH, SKULL 

OBSTETRICS AND GYNECOLOGY PANEL 

Section 
No. 
************ 
* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * ** 
* * * * * * * * * * * * * ** 

Regulation Name 
Product Code - Device Name 

(NONE) 

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OPHTHALMOLOGY PANEL (886) 

Section 
No. 
************ 
* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * ** 
* * * * * * * * * * * * * ** 

Regulation Name 
Product Code - Device Name 

886.1780 

886.1940 

886.4070 

886.4300 

886.5850 

RETINOSCOPE 
HKM - RETINOSCOPE, BATTERY-POWERED 

TONOMETER STERILIZER 
HKZ - STERILIZER, TONOMETER 

POWERED CORNEAL BURR 
HQS - BURR, CORNEAL, AC-POWERED 
HOG - BURR, CORNEAL, BATTERY-POWERED 
HRG - ENGINE, TREPHINE, ACCESSORIES, 
AC-POWERED 
HFR - ENGINE, TREPHINE, ACCESSORIES, 
BATTERY-POWERED 
HLD - ENGINE, TREPHINE, ACCESSORIES, 
GAS-POWERED 

KERATOME 
HNO - KERATONE, AC-POWERED 
HMY - KERATONE, BATTERY-POWERED 

SUNGLASSES (NON-PRESCRIPTION) 
HQY - SUNGLASSES (NON-PRESCRIPTION 
INCLUDING PHOTOSENSITIVE) 

ORTHOPEDIC PANEL (888) 

Section 
No. 
************ 
* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * ** 
* * * * * * * * * * * * * ** 

Regulation Name 
Product Code - Device Name 

888.1500 

888.4150 

AC-POWERED GONIOMETER 
KQX - GONIOMETER, AC-POWERED 
CALIPERS FOR CLINICAL USE 
KTZ - CALIPER 

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PHYSICAL MEDICINE PANEL (890) 

- 

Section 
No. 
************ 
* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * ** 
* * * * * * * * * * * * * ** 

Regulation Name 
Product Code - Device Name 

890.3850 

890.5180 

890.5710 

MECHANICAL WHEELCHAIR 
LBE - STROLLER, ADAPTIVE 
IOR - WHEELCHAIR, MECHANICAL 

MANUAL PATIENT ROTATION BED 
INY - BED, PATIENT ROTATION, MANUAL 

HOT OR COLD DISPOSABLE PACK 
IMD - PACK, HOT OR COLD, DISPOSABLE 

RADIOLOGY PANEL (892) 

Section 
No. 
************ 
* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * ** 
* * * * * * * * * * * * * ** 

Regulation Name 
Product Code - Device Name 

892.1100 

892.1110 

892.1300 

892.1320 

892.1330 

892.1410 

SCINTILLATION GAMMA CAMERA 
IYX - CAMERA, SCINTILLATION (GAMMA) 

POSITRON CAMERA 
IZC - CAMERA, POSITRON 

NUCLEAR RECTILINEAR SCANNER 
IYW - SCANNER, RECTILINEAR, NUCLEAR 

NUCLEAR UPTAKE PROBE 
IZD - PROBE, UPTAKE, NUCLEAR 

NUCLEAR WHOLE BODY SCANNER 
JAM - SCANNER, WHOLE BODY, NUCLEAR 

NUCLEAR ELECTROCARDIOGRAPH 
SYNCHRONIZER 
IVY - SYNCHRONIZER, ELECTROCARDIOGRAPH, 
NUCLEAR 

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892.1890 

892.1910 

892.1960 

892.1970 

892.5650 

RADIOGRAPHIC-FILM ILLUMINATOR 
IXC - ILLUMINATOR, RADIOGRAPHIC-FILM 
JAG - ILLUMINATOR, RADIOGRAPHIC-FILM, 
EXPLOSION-PROOF 

RADIOGRAPHIC GRID 
IXJ -GRID, RADIOGRAPHIC 

RADIOGRAPHIC INTENSIFYING SCREEN 
WAM - SCREEN, INTENSIFYING, RADIOGRAPHIC 

RADIOGRAPHIC ECG/RESPIRATQR 
SYNCHRONIZER 
IXO - SYNCHRONIZER, ECG/RESPIRATOR, 
RADIOGRAPHIC 

MANUAL RADIONUCLIDE APPLICATOR SYSTEM 
IWG - SYSTEM, APPLICATOR, RADIONUCLIDE, 
MANUAL 

GENERAL AND PLASTIC SURGERY PANEL (878) 

Section 
No. 
************ 
* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * ** 
* * * * * * * * * * * * * ** 

Regulation Name 
Product Code - Device Name 

878.4200 

INTRODUCTION/DRAINAGE CATHETER AND 
ACCESSORIES 
KGZ - ACCESSORIES, CATHETER 
GCE - ADAPTOR, CATHETER 
FGY - CANNULA, INJECTION 
GBA - CATHETER, BALLOON TYPE 
GBZ - CATHETER, CHOLANGIOGRAPHY 
GBQ - CATHETER, CONTINUOUS IRRIGATION 
GBY - CATHETER, EUSTACHIAN, GENERAL & 
PLASTIC SURGERY 
JCY - CATHETER, INFUSION 
GBX - CATHETER, IRRIGATION 
GBP - CATHETER, MULTIPLE LUMEN 
GBO - CATHETER, NEPHROSTOMY, GENERAL & 
PLASTIC SURGERY 
GBN - CATHETER, PEDIATRIC, GENERAL & 
PLASTIC SURGERY 

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GBW - CATHETER, PERITONEAL 
GBS - CATHETER, VENTRICULAR, GENERAL & 
PLASTIC SURGERY 
GCD - CONNECTOR, CATHETER 
GCC - DILATOR, CATHETER 
GCB - NEEDLE, CATHETER 

REMOVABLE SKIN CLIP 
FZQ - CLIP, REMOVABLE (SKIN) 

SURGEON'S GLOVES 
KGO - SURGEON'S GLOVES 

NONPOWERED, SINGLE PATIENT, PORTABLE 
SUCTION APPARATUS 
GCY - APPARATUS, SUCTION, SINGLE PATIENT 
USE, PORTABLE, NONPOWERED 

878.4320 

878.4460 

878.4680 

878.4760 

REMOVABLE SKIN STAPLE 
GDT - STAPLE, REMOVABLE (SKIN) 

GENERAL AND PLASTIC SURGERY PANEL (878) (CONTINUED) 

Section 
No. 
************ 
* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * ** 
* * * * * * * * * * * * * * ** 

Regulation Name 
Product Code - Device Name 

878.4820 

AC-POWERED, BATTERY-POWERED, AND 
PNEUMATICALLY POWERED SURGICAL 
INSTRUMENT MOTOR 
GFG - BIT, SURGICAL 
GFA - BLADE, SAW, GENERAL & PLASTIC 
SURGERY 
DWH - BLADE, SAW, SURGICAL, 
CARDIOVASCULAR 
BRZ - BOARD, ARM (WITH COVER) 
GFE - BRUSH, DERMABRASION 
GFF - BUR, SURGICAL, GENERAL & PLASTIC 
SURGERY 
KDG - CHISEL (OSTEOTOME) 
GFD - DERMATOME 
GFC - DRIVER, SURGICAL, PIN 
GFB - HEAD, SURGICAL, HAMMER 

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878.4960 

GEY - MOTOR, SURGICAL INSTRUMENT, 
AC-POWERED 
GET - MOTOR, SURGICAL INSTRUMENT, 
PNEUMATIC POWERED 
DWI - SAW, ELECTRICALLY POWERED 
KFK - SAW, PNEUMATICALLY POWERED 
HAB - SAW, POWERED, AND ACCESSORIES 

AIR OR AC-POWERED OPERATING TABLE AND 
AIR OR AC-POWERED OPERATING CHAIR & 
ACCESSORIES 

GBB - CHAIR, SURGICAL, AC-POWERED 
FQO - TABLE, OPERATING-ROOM, AC-POWERED 
GDC - TABLE, OPERATING-ROOM, ELECTRICAL 
FWW - TABLE, OPERATING-ROOM, PNEUMATIC 
JEA - TABLE, SURGICAL WITH ORTHOPEDIC 
ACCESSORIES, AC-POWERED 

880.5090 

LIQUID BANDAGE 
KMF - BANDAGE, LIQUID 

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TABLE 2 

CLASS II MEDICAL DEVICES INCLUDED 
IN SCOPE OF PRODUCT COVERAGE 
AT BEGINNING OF TRANSITION PERIOD 

• U.S. to develop guidance documents identifying U.S. requirements and EC to 
identify standards needed to meet EC requirements 

RA 

892.1000 

Diagnostic  Ultrasound: 

RA 

892.1540 

MAGNETIC RESONANCE DIAGNOSTIC DEVICE 
MOS - COIL, MAGNETIC RESONANCE. SPECIALTY 
LNH - SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING 
LNI - SYSTEM, NUCLEAR MAGNETIC RESONANCE  SPECTROSCOPIC 

NONFETAL ULTRASONIC MONITOR 
JAF - MONITOR.  ULTRASONIC, NONFETAL 

RA 

892.1550 

ULTRASONIC PULSED DOPPLER IMAGING SYSTEM 
IYN - SYSTEM, IMAGING, PULSED DOPPLER.  ULTRASONIC 

RA 

892.1560 

ULTRASONIC PULSED ECHO IMAGING SYSTEM 
IYO - SYSTEM. IMAGING, PULSED ECHO, ULTRASONIC 

RA 

892.1570 

DIAGNOSTIC ULTRASONIC TRANSDUCER 

ITX - TRANSDUCER,  ULTRASONIC, DIAGNOSTIC 

Diagnostic  X-Ray  Imaging Devices (except mammographie x-ray systems): 

RA 

RA 

892.1600 

892.1650 

ANGIOGRAPHIC X-RAY SYSTEM 
IZI - SYSTEM. X-RAY, ANGIOGRAPHIC 
IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM 
MQB - SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) 
JAA - SYSTEM, X-RAY, FLUOROSCOPIC,  IMAGE-INTENSIFIED 

RA 

892.1680 

STATIONARY X-RAY SYSTEM 
KPR - SYSTEM. X-RAY. STATIONARY 

RA 

892.1720 

MOBILE X-RAY SYSTEM 
IZL - SYSTEM, X-RAY, MOBILE 

RA 

892.1740 

TOMOGRAPHIC X-RAY SYSTEM 
IZF - SYSTEM, X-RAY, TOMOGRAPHIC 

RA 

892.1750 

COMPUTED TOMOGRAPHY  X-RAY SYSTEM 
JAK - SYSTEM. X-RAY, TOMOGRAPHY. COMPUTED 

ECG-Related Devices: 

CV 

870.2340 

ELECTROCARDIOGRAPH 
DPS -  ELECTROCARDIOGRAPH 
MLC - MONITOR. ST SEGMENT 

CV 

870.2350 

ELECTROCARDIOGRAPH  LEAD SWITCHING  ADAPTOR 
DRW - ADAPTOR, LEAD SWITCHING.  ELECTROCARDIOGRAPH 

CV 

870.2360 

ELECTROCARDIOGRAPH  ELECTRODE 
DRX - ELECTRODE,  ELECTROCARDIOGRAPH 

CV 

870.2370 

ELECTROCARDIOGRAPH  SURFACE ELECTRODE TESTER 
KRC - TESTER.  ELECTRODE. SURFACE,  ELECTROCARDIOGRAPHIC 

NE 

8821400 

ELECTROENCEPHALOGRAPH 

93 

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HO 

880.5725 

GWQ -  ELECTROENCEPHALOGRAPH 

INFUSION  PUMP (external only) 
MRZ - ACCESSORIES. PUMP, INFUSION 
FRN - PUMP, INFUSION 
LZF - PUMP. INFUSION. ANALYTICAL SAMPLING 
MEB - PUMP, INFUSION, ELASTOMERIC 
LZH - PUMP, INFUSION, ENTERAL 
MHD - PUMP. INFUSION, GALLSTONE DISSOLUTION 
LZG - PUMP, INFUSION, INSULIN 
MEA - PUMP, INFUSION, PCA 

Ophthalmic Instruments: 

OP 

886.1570 

OPHTHALMOSCOPE 
HLI - OPHTHALMOSCOPE, AC-POWERED 
HLJ - OPHTHALMOSCOPE,  BATTERY-POWERED 

OP 

886.1780 

RETINOSCOPE 
HKL - RETINOSCOPE, AC-POWERED 

OP 

886.1850 

AC-POWERED SLIT-LAMP BIOMICROSCOPE 
HJO - BIOMICROSCOPE. SLIT-LAMP, AC-POWERED 

OP 

886.4150 

VITREOUS ASPIRATION AND CUTTING  INSTRUMENT 
MMC - DILATOR. EXPANSIVE IRIS (ACCESSORY) 

HQE - INSTRUMENT, VITREOUS ASPIRATION AND CUTTING. AC-POWERED 
HKP - INSTRUMENT, VITREOUS ASPIRATION AND CUTTING,  BATTERY-POWERED 
MLZ - VITRECTOMY, INSTRUMENT CUTTER 

OP 

886.4670 

PHACOFRAGMENTATION  SYSTEM 
HOC - UNIT,  PHACOFRAGMENTATION 

SU 

878.4580 

SURGICAL LAMP 
HBI - ILLUMINATOR, FIBEROPTIC, SURGICAL FIELD 
FTF - ILLUMINATOR. NON-REMOTE 
FTG - ILLUMINATOR, REMOTE 
HJE - LAMP, FLUORESCEIN. AC-POWERED 
FQP - LAMP, OPERATING-ROOM 
FTD - LAMP, SURGICAL 
GBC - LAMP, SURGICAL, INCANDESCENT 
FTA - LIGHT, SURGICAL, ACCESSORIES 
FSZ - LIGHT, SURGICAL, CARRIER 
FSY - LIGHT, SURGICAL, CEILING MOUNTED 
FSX - LIGHT. SURGICAL, CONNECTOR 
FSW - LIGHT, SURGICAL, ENDOSCOPIC 
FST - LIGHT. SURGICAL. FIBEROPTIC 
FSS - LIGHT. SURGICAL, FLOOR STANDING 
FSO - LIGHT. SURGICAL. INSTRUMENT 

NE 

882.5890 

TRANSCUTANEOUS  ELECTRICAL NERVE STIMULATOR  FOR PAIN RELIEF 
GZJ - STIMULATOR. NERVE. TRANSCUTANEOUS.  FOR PAIN RELIEF 

Noninvasive  Blood Pressure Measurement Devices: 

CV 

870.1120 

BLOOD PRESSURE CUFF 
DXQ - CUFF. BLOOD-PRESSURE 

CV 
oscillometric) 

870.1130 

NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM (except non-

DXN - SYSTEM. MEASUREMENT. BLOOD-PRESSURE. NON-INVASIVE 

94 

107 

Initialled on 20 June 1997 

US - EC  MRA Medical Devices Annex 

HO 

880.6880 

STEAM STERILIZER (greater than 2 cubic  feet) 
FLE - STERILIZER. STEAM 

Clinical Thermometers: 
880.2910 
HO 

CLINICAL ELECTRONIC THERMOMETER (except tympanic or pacifier) 
FLL - THERMOMETER, ELECTRONIC, CLINICAL 

AN 

AN 

868.5630 

NEBULIZER 
CAF - NEBULIZER (DIRECT PATIENT INTERFACE) 

868.5925 

POWERED EMERGENCY VENTILATOR 

Hypodermic Needles and Syringes (except anti-stick  and self-destruct): 

HO 

880.5570 

HYPODERMIC SINGLE LUMEN NEEDLE 
MMK. - CONTAINER, SHARPES 
FMI - NEEDLE, HYPODERMIC. SINGLE LUMEN 
MHC - PORT, INTRAOSSEOUS. IMPLANTED 

HO 

880.5860 

PISTON SYRINGE 
FMF - SYRINGE, PISTON 

OR 

888.3020 

INTRAMEDULLARY  FIXATION ROD 
HSB - ROD, FIXATION, INTRAMEDULLARY  AND ACCESSORIES 

External  Fixators (except devices with no external components): 

OR 
ACCESSORIES 

888.3030 

COMPONENT 

OR 

888.3040 

Selected  Dental Materials: 

DE 

872.3060 

SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCES & 

KTT - APPLIANCE, FIXATION. NAIL/BLADE/PLATE COMBINATION, MULTIPLE 

SMOOTH OR THREADED METALLIC BONE FIXATION FASTENER 
HTY - PIN. FIXATION. SMOOTH 
JDW - PIN, FIXATION, THREADED 

GOLD BASED ALLOYS AND PRECIOUS METAL ALLOYS FOR CLINICAL USE 
EJT - ALLOY, GOLD BASED, FOR CLINICAL USE 
EJS - ALLOY, PRECIOUS METAL. FOR CLINICAL USE 

DE 

872.3200 

RESIN TOOTH BONDING AGENT 
KLE - AGENT, TOOTH BONDING, RESIN 

DE 

872.3275 

DENTAL CEMENT 
EMA - CEMENT. DENTAL 
EMB - ZINC OXIDE EUGENOL 

DE 

872.3660 

IMPRESSION MATERIAL 
ELW - MATERIAL, IMPRESSION 

DE 

872.3690 

TOOTH SHADE RESIN MATERIAL 
EBF - MATERIAL. TOOTH SHADE, RESIN 

DE 

872.3710 

BASE METAL ALLOY 
EJH - METAL. BASE 

Latex Condoms: 

OB 

884.5300 

CONDOM 
HIS - CONDOM 

95 
108 

Initialled on 20 June 1997 

US - EC  MRA Medical Devices Annex 

TABLE 3 

MEDICAL DEVICES FOR POSSIBLE INCLUSION 
IN SCOPE OF PRODUCT COVERAGE 
DURING OPERATIONAL PERIOD 

Anesthesiology Panel 
Section 
Product 
No 
Family 

Device Name 

Tier 

Anesthesia 
Devices 

868.5160 

Gas machine for anesthesia or analgesia 

2 

868.5270 

Breathing system heater 

868.5440 

Portable oxygen generator 

868.5450 

Respiratory gas humidifier 

868.5630 

Nebulizer 

-

868.5710 

Electrically powered oxygen tent 

868.5880 

Anesthetic vaporizer 

Gas 
Analyser 

868.1040 

Powered Algesimeter 

868.1075 

Argon gas analyzer 

868.1400 

Carbon dioxide gas analyzer 

868.1430 

Carbon monoxide gas analyzer 

868.1500 

Enflurane gas analyzer 

868.1620 

Halothane gas analyzer 

868.1640 

Helium gas analyzer 

868.1670 

Neon gas analyzer 

868.1690 

Nitrogen gas analyzer 

868.1700 

Nitrous oxide gas analyzer 

868.1720 

Oxygen gas analyzer, 

868.1730 

Oxygen uptake computer 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

96 

109 

Initialled on 20 June  1997 

US - EC  MRA Medical Devices Annex 

Peripheral 
Nerve 
Stimulators 
Respiratory 
Monitoring 

868.2775 

Electrical peripheral nerve stimulator 

868.1750 

Pressure plethysmograph 

868.1760 

Volume plethysmograph 

868.1780 

Inspiratory airway pressure meter 

868.1800 

Rhinoanemometer 

868.1840 

Diagnostic  spirometer 

868.1850 

Monitoring  spirometer 

868.1860 

Peak-flow meter for  spirometry 

868.1880 

Pulmonary-function  data calculator 

868.1890 

868.1900 

868.2025 

868.2375 

868.2480 

868.2500 

868.2550 

Predictive pulmonary-function  value 
calculator 
Diagnostic  pulmonary-function 
interpretation  calculator 
Ultrasonic air embolism  monitor 

Breathing frequency  monitor (except 
apnea detectors) 
Cutaneous carbon dioxide (PCCO2) 

monitor 
Cutaneous oxygen monitor (for an  infant 
not under gas anesthesia) 
Pneumotachomometer 

868.2600 

Airway pressure monitor 

868.5665 

Powered  percussor 

868.5690 

Incentive spirometer 

Ventilator 

868.5905 

Noncontinuous ventilator (IPPB) 

868.5925 

Powered emergency  ventilator 

868.5935 

External negative pressure ventilator 

868.5895 

Continuous ventilator 

868.5955 

868.6250 

Intermittent mandatory  ventilation 
attachment 
Portable air compressor 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

97 

110 

Initialled on 20 June  1997 

US - EC  MRA Medical Devices Annex 

Cardiovascular Panel 

Product 
Family 

Section 
No 

Device Name 

Tier 

Cardiovascular 
Diagnostic 

870.1425 

Programmable diagnostic  computer 

870.1450 

Densitometer 

870.2310 

Apex cardiograph  (vibrocardiograph) 

870.2320 

B allistocardiograph 

870.2340 

Electrocardiograph 

870.2350 

870.2360 

870.2370 

870.2400 

Electrocardiograph  lead switching 
adaptor 
Electrocardiograph  electrode 

Electrocardiograph  surface  electrode 
tester 
Vectorcardiograph 

870.2450 

Medical cathode-ray tube display 

870.2675 

Oscillometer 

870.2840 

Apex cardiographic  transducer 

870.2860 

Heart sound  transducer 

Cardiovascular 
Monitoring 

Valve, pressure relief, 
cardiopulmonary  bypass 
Blood pressure alarm 

870.1100 

870.1110 

Blood pressure computer 

870.1120 

Blood pressure cuff 

870.1130 

870.1140 

870.1220 

870.1270 

Noninvasive blood pressure 
measurement system 
Venous blood pressure manometer 

Electrode recording catheter or 
electrode recording probe 
Intracavitary phonocatheter system 

870.1875 

Stethoscope  (electronic) 

2 

2 

2 

2 

2 

1 

2 

2 

1 

1 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

98 

111 

Initialled on 20 June  1997 

US - EC  MRA Medical Devices Annex 

870.2050 

870.2060 

870.2100 

Biopotential amplifier  and signal 
conditioner 
Transducer signal amplifier  and 
conditioner 
Cardiovascular  blood flow-meter 

870.2120 

Extravascular blood flow  probe 

870.2300 

870.2700 

Cardiac monitor  (including 
cardiotachometer  and rate alarm) 
Oximeter 

870.2710 

Ear oximeter 

870.2750 

Impedance  phlebograph 

870.2770 

Impedance plethysmograph 

-

870.2780 

870.2850 

Hydraulic, pneumatic, or photoelectric 
plethysmography 
Extravascular blood pressure transducer 

870,2870 

Catheter tip pressure transducer 

870.2880 

Ultrasonic transducer 

870.2890 

Vessel occlusion transducer 

870.2900 

870.2910 

870.2920 

870.4205 

870.4220 

870.4240 

870.4250 

870.4300 

870.4310 

870.4330 

870.4340 

Patient transducer and electrode cable 
(including connector) 
Radiofrequency  physiological signal 
transmitter and receiver 
Telephone  electrocardiograph 
transmitter and receiver 
Cardiopulmonary  bypass bubble detector 

Cardiopulmonary bypass heart-lung 
machine console 
Cardiovascular bypass heat exchanger 

Cardiopulmonary  bypass temperature 
controller 
Cardiopulmonary bypass gas control unit 

Cardiopulmonary  bypass coronary 
pressure gauge 
Cardiopulmonary  bypass on-line blood 
gas monitor 
Cardiopulmonary  bypass level sensing 
monitor and/or control 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

99 

JL  JL  r-J 

Initialled on 20 June 1997 

US - EC  MRA Medical Devices Annex 

870.4370 

870.4380 

870.4410 

870.5050 

Roller-type cardiopulmonary  bypass 
blood pump 
Cardiopulmonary bypass pump speed 
control 
Cardiopulmonary  bypass in-line 
blood  2as sensor 
Patient care suction apparatus 

870.5900 

Thermal regulation system 

Cardiovascular 
Therapeutic 

Defibrillator 

870.5300 

DC-defribrillator  (including  paddles) 

870.5325 

Defibrillator  tester 

Echocardiograph  870.2330  Echocardiograph 

Pacemaker & 
Accessories 

870.1750 

870.3630 

870.3640 

870.3720 

External programmable  pacemaker 
pulse generator 
Pacemaker generator  function 
analyzer 
Indirect pacemaker generator  function 
analyzer 
Pacemaker electrode function  tester 

Miscellaneous 

870.1800 

Withdrawal-infusion  pump 

870.2800 

Medical magnetic tape recorder 

None 

Batteries, rechargeable, class II 
devices 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

100 

113 

Initialled on 20 June 1997 

US - EC  MRA Medical Devices Annex 

Dental Panel 

Product 
Family 

Section 
No 

Device Name 

Tier 

Dental 
Equipment 

872.1720 

Pulp tester 

872.1740 

Caries detection device 

872.4120 

Bone cutting instrument and accessories 

872.4465 

Gas-powered jet  injector 

872.4475 

Spring-powered jet  injector 

872.4600 

Intraoral ligature and wire lock 

872.4840 

Rotary scaler 

872.4850 

Ultrasonic scaler 

872.4920 

872.6070 

Dental electrosurgical unit and 
accessories 
Ultraviolet activator for  polymerization 

872.6350 

Ultraviolet detector 

Dental 
Material 

872.3050 

Amalgam alloy 

872.3060 

872.3200 

Gold-based alloys and precious metal 
alloys for clinical use 
Resin tooth bonding  agent 

872.3250 

Calcium hydroxide cavity liner 

872.3260 

Cavity varnish 

872.3275 

872.3300 

Dental cement (other than zinc oxide-
eugenol) 
Hydrophilic resin coating for dentures 

872.3310 

Coating material for resin fillings 

872.3590 

Preformed  plastic denture tooth 

872.3660 

Impression material 

872,3690 

Tooth shade resin material 

872.3710 

Base metal alloy 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

101 

114 

Initialled on 20 June 1997 

US - EC  MRA Medical Devices Annex 

872.3750 

872.3760 

872.3765 

Bracket adhesive resin and tooth 
conditioner 
Denture relining, repairing, or rebasing 
resin 
Pit and fissure sealant and conditioner 

872.3770 

Temporary crown and bridge resin 

872.3820 

872.3920 

Root canal filling resin (other than 
chloroform  use) 
Porcelain tooth 

Dental X-ray  872.1800 

Extraoral source x-ray system 

872.1810 

Intraoral source x-ray system 

Dental 
Implants 

872.4880 

Intraosseous fixation  screw or wires 

872.3890 

Endodontic stabilizing  splint 

Orthodontic 

872.5470  Orthodontic plastic bracket 

Ear/Nose/Throat Panel 

Product 
Family 

Section 
No 

Device Name 

Diagnostic 
Equipment 

874.1050 

Audiometer 

874.1090 

Auditory impedance tester 

874.1120 

874.1325 

Electronic noise generator for 
audiometric testing 
Electroglottograph 

874.1820 

Surgical nerve stimulator/locator 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

Tier 

2 

2 

2 

2 

2 

102 

115 

Initialled on 20 June 1997 

US - EC  MRA Medical Devices Annex 

Hearing 
Aids 

874.3300 

Hearing aid (for  bone-conduction) 

874.3310 

874.3320 

874.3330 

Hearing aid calibrator and analysis 
system 
Group hearing aid or group auditory 
trainer 
Master hearing aid 

Surgical 
Equipment 

874.4250 

874.4490 

874.4500 

Ear, nose, and throat electric or 
pneumatic surgical drill 
Argon laser for otology, rhinology, and 
laryngology 
ENT microsurgical carbon dioxide laser 

2 

2 

2 

2 

1 

2 

2 

Gastroenterologv/Urologv Panel 

Section 
No 
876.1500 

Device Name 

Endoscope and accessories 

Tier 

2 

Product Family 

Endoscope 
(including 
angioscopes, 
laparscopes, 
ophthalmic 
endoscopes) 

876.4300 

Endoscopic electrosurgical  unit and 
accessories 

2 

Gastroenterology 

876.1725  Gastrointestinal motility monitoring 

1 

system 

Hemodialysis 

876.5600 

876.5630 

876.5665 

876.5820 

876.5830 

Sorbent regenerated dialysate 
delivery system for  hemodialysis 
Peritoneal dialysis system and 
accessories 
Water purification  system  for 
hemodialysis 
Hemodialysis system and 
accessories 
Hemodialyzer with disposable insert 
(kiil-type) 

2 

2 

2 

2 

2 

103 

116 

Initialled on 20 June 1997 

US - EC  MRA Medical Devices Annex 

Lithotriptor 

876.4500  Mechanical  lithotriptor 

Urology 
Equipment 

876.1620 

Urodynamics measurement system 

876.5320 

876.5880 

Nonimplanted  electrical  continence 
device 
Isolated kidney perfusion  and transport 
system and accessories 

General  Hospital Panel 

2 

2 

2 

2 

Product Family  Section 

Device Name 

Tier 

No 

Infusion  Pumps 
and Systems 

880.2420 

880.2460 

880.5430 

Electronic monitor for gravity  flow 
infusion  systems 
Electrically powered spinal fluid 
pressure monitor 
Nonelectrically powered fluid injector 

880.5725 

Infusion  pump 

Neonatal 
Incubators 

880.5400 

Neonatal incubator 

880.5410 

Neonatal transport incubator 

880.5700 

Neonatal phototherapy unit 

Piston  Syringes  880.5570 

Hypodermic single lumen needle 

880.5860 

Piston syringe (except anti-stick) 

880.6920 

Syringe needle introducer 

Miscellaneous 

880.2910 

Clinical electronic  thermometer 

880.2920 

Clinical mercury  thermometer 

880.5100 

AC-powered  adjustable  hospital bed 

2 

2 

2 

2 

2 

2 

2 

1 

1 

2 

2 

2 

1 

104 

117 

Initialled  on 20 June  1997 

US - EC  MRA Medical Devices Annex 

880.5500 

AC-powered patient  lift 

880.6880 

Steam  Sterilizer (greater than 2 cubic 
feet) 

2 

2 

Neurology Panel 

Product Family 

Section 
No 

Device Name 

Tier 

? 

7 

882.1020 

Rigidity analyzer 

882.1610 

Alpha monitor 

Neuro-Diagnostic 

882.1320 

Cutaneous electrode 

882.1340 

Nasopharyngeal  electrode 

882.1350 

Needle electrode 

882.1400 

Electroencephalograph 

882.1460 

Nystagmograph 

882.1480 

Neurological  endoscope 

882.1540 

882.1550 

882.1560 

882.1570 

882.1620 

882.1835 

882.1845 

882.1855 

882.5050 

Galvanic skin response 
measurement  device 
Nerve conduction  velocity 
measurement  device 
Skin potential  measurement 
device 
Powered  direct-contact 
temperature  measurement 
device 
Intracranial  pressure 
monitorins device 
Physiological signal  amplifier 

Physiological signal 
conditioner 
Electroencephalogram  (EEG) 
telemetry system 
Biofeedback  device 

Echoencephalography 

882.1240  Echoencephalograph 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

105 

118 

Initialled  on 20 June  1997 

US - EC  MRA Medical Devices Annex 

RPG 

882.4400  Radiofrequency  lesion generator 

Neuro 
Surgery 

none 

Electrode, spinal epidural 

882.4305 

882.4310 

882.4360 

Powered compound cranial drills, burrs, 
trephines, and their accessories 
Powered simple cranial drills burrs, 
trephines and accessories 
Electric cranial drill motor 

882.4370 

Pneumatic cranial drill motor 

882.4560 

Stereotaxic  instrument 

882.4725 

Radiofrequency  lesion probe 

882.4845 

Powered rongeur 

882.5500 

Lesion temperature monitor 

Stimulators 

882.1870 

Evoked response electrical  stimulator 

882.1880 

Evoked response mechanical  stimulator 

882.1890 

Evoked response photic  stimulator 

882.1900 

Evoked response auditory  stimulator 

882.1950 

Tremor transducer 

882.5890 

Transcutaneous electrical nerve 
stimulator for pain relief 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

106 

119 

Initialled on 20 June 1997 

US - EC  MRA Medical Devices Annex 

Obstetrics/Gvnecologv Panel 

Product Family 

Fetal 
Monitoring 

Gynecological 
Surgery Equip. 

Section 
No 
884.1660 

884.1690 

884.2225 

884.2600 

884.2640 

884.2660 

884.2675 

884.2700 

884.2720 

884.2740 

884.2960 

884.1720 

884.4160 

884.4550 

884.4120 

884.5300 

Device Name 

Tier 

Transcervical endoscope  (amnioscope) 
and accessories 
Hysteroscope and accessories  (for 
performance  standards) 
Obstetric-gynecologic  ultrasonic 
imager 
Fetal cardiac monitor 

Fetal phonocardiographic monitor and 
accessories 

Fetal ultrasonic monitor and 
accessories 
Fetal scalp circular (spiral) electrode 
and applicator 
Intrauterine pressure monitor and 
accessories 
External uterine contraction monitor 
and accessories 
Perinatal monitoring system and 
accessories 
Obstetric ultrasonic transducer and 
accessories 

Gynecologic laparoscope and 
accessories 
Unipolar endoscopic  coagulator-cutter 
and accessories 
Gynecologic surgical laser 

Gynecologic electrocautery  and 
accessories 
Condom 

2 

2 

2 

2 

2 

2 

1 

2 

2 

2 

2 

2 

2 

2 

2 

2 

107 

JL /*,  \j 

Initialled  on 20 June  1997 

US - EC  MRA Medical Devices Annex 

Product 
Family 

Section 
No 

Device Name 

Ophthalm. 
Implants 

Contact 
Lens 

886.3320  Eye sphere implant 

886.1385 

886.5916 

Polymethylmethacrylate  (PMMA) 
diagnostic contact lens 
Rigid gas permeable contact lens (daily 
wear only) 

Diagnostic 
Equipment 

886.1120 

Opthalmic camera 

886.1220 

Corneal electrode 

886.1250 

Euthyscope  (AC-powered) 

886.1360 

Visual field laser instrument 

886.1510 

Eye movement monitor 

886.1570 

Ophthalmoscope 

886.1630 

AC-powered  photostimulator 

886.1640 

Ophthalmic  preamplifier 

886.1670 

Ophthalmic isotope uptake probe 

886.1780 

Retinoscope (AC-powered device) 

886.1850 

,AC-powered slitlamp  biomicroscope 

886.1930 

Tonometer and accessories 

886.1945 

Transilluminator  (AC-powered  device) 

886.3130 

Ophthalmic conformer 

886.4670 

Phacofragmentation  System 

886.3340 

Extraocular orbital implant 

886.3800 

Scleral shell 

(Diagnostic/ 
Surgery 
Equipment) 

Ophthalm. 
Implants 

Tier 

2 

2 

2 

2 

2 

1 

2 

2 

2 

2 

108 

121 

Initialled on 20 June 1997 

US - EC  MRA Medical Devices Annex 

Surgical 
Equipment 

880.5725 

Infusion  pump (performance  standards) 

886.3100 

Ophthalmic tantalum clip 

886.3300 

886.4100 

886.4115 

886.4150 

886.4170 

886.4250 

886.4335 

886.4390 

Absorbable implant (scleral buckling 
method) 
Radiofrequency  electrosurgical cautery 
apparatus 
Thermal cautery unit 

Vitreous aspiration and cutting 
instrument 
Cryophthalmic unit 

Ophthalmic electrolysis unit (AC-
powered device) 
Operating headlamp  (AC-powered 
device) 
Ophthalmic laser 

886.4392 

Nd:YAG laser for posterior capsulotomy 

886.4400 

Electronic metal locator 

886.4440 

AC-powered  magnet 

886.4610 

Ocular pressure  applicator 

886.4690 

Ophthalmic photocoagulator 

886.4790 

Ophthalmic sponge 

886.5100 

Ophthalmic beta radiation source 

none 

Ophthalmoscopes, replacement batteries, 
hand-held 

2 

2 

2 

2 

2 

2 

2 

1 

1 

2 

2 

1 

1 

2 

2 

2 

2 

1 

Orthopedic Panel 

Product 
Family 

Section 
No 

Device Name 

Tier 

109 

1  oo 

JL  fi*>  ,'j 

Initialled on 20 June 1997 

US - EC  MRA Medical Devices Annex 

Implants 

888.3010 

Bone fixation cerclage 

888.3020 

Intramedullary fixation  rod 

888.3030 

888.3040 

888.3050 

888.3060 

Single/multiple component metallic 
bone fixation appliances and accessories 
Smooth or threaded metallic bone 
fixation  fastener 
Spinal interlaminal fixation  orthosis 

Spinal intervertebral body fixation 
orthosis 

Surgical 
Equipment 

888.1240 

AC-powered  dynamometer 

888.4580 

none 

none 

none 

none, 

none 

none 

Sonic surgical instrument and 
accessories/attachments 
Accessories, fixation,  spinal interlaminal 

Accessories, fixation,  spinal 
intervertebral body 
Monitor, pressure, intracompartmental 

Orthosis, fixation, spinal intervertebral 
fusion 
Orthosis, spinal pedicle  fixation 

System, cement removal extraction 

1 

2 

2 

2 

2 

2 

2 

2 

2 

2 

2 

1 

2 

Physical Medicine Panel 

Product 
Family 

Section 
No 

Device Name 

Diagnostic 
Equipment 

890.1225 

Chronaximeter 

890.1375 

Diagnostic  electromyograph 

890.1385 

890.1450 

Diagnostic electromyograph  needle 
electrode 
Powered reflex  hammer 

890.1850 

Diagnostic muscle stimulator 

or (Therapy) 

890.5850 

Powered  muscle  stimulator 

Tier 

2 

2 

2 

2 

2 

2 

110 

123 

Initialled  on 20 June  1997 

US - EC  MRA Medical Devices Annex 

Therapeutic 
Equipment 

890.5100 

Immersion hydrobath 

890.5110 

Paraffin  bath 

890.5500 

Infrared  lamp 

890.5720 

Water circulating hot or cold pack 

890.5740 

Powered heating pad 

2 

2 

2 

2 

2 

Radiology  Panel 

Product 
Family 

Section No  Device Name 

Tier 

MRI 

892.1000  Magnetic resonance diagnostic device 

2 

Ultrasound 
Diagnostic 

884.2660 

892.1540 

892.1560 

892.1570 

892.1550 

Fetal ultrasonic monitor and 
accessories 
Nonfetal  ultrasonic monitor 

Ultrasonic pulsed echo imaging 
system 
Diagnostic ultrasonic  transducer 

Ultrasonic pulsed doppler imaging 
system 

Angiographic 

892.1600  Angiographic x-ray system 

2 

2 

2 

2 

111 

124 

Initialled on 20 June 1997 

US - EC  MRA Medical Devices Annex 

Diagnostic 
X-Ray 

892.1610 

Diagnostic x-ray beam-limiting  device 

892.1620 

Cine or spot fluorographic  x-ray Camera 

892.1630 

Electrostatic x-ray imaging  system 

892.1650 

892.1670 

Image-intensified  fluoroscopic  x-ray 
system 
Spot film  device 

892.1680 

Stationary x-ray system 

892.1710 

Mammographic x-ray system 

892.1720 

Mobile x-ray system 

892.1740 

Tomographic x-ray system 

892.1820 

Pneumoencephalographic  chair 

892.1850 

Radiographic film  cassette 

892.1860 

Radiographic film/cassestte  changer 

892.1870 

892.1900 

Radiographic film/cassette  changer 
programmer 
Automatic radiographic film  processor 

892.1980 

Radiologic table 

CT Scanner  892.1750  Computed tomography x-ray system 

Radiation 
Therapy 

* 

892.5050 

892.5300 

892.5700 

892.5710 

Medical charged-particle radiation 
therapy system 
Medical neutron radiation therapy 
system 
Remote controlled radionuclide-
applicator system 
Radiation therapy beam-shaping  block 

892.5730 

Radionuclide brachytherapy  source 

892.5750 

Radionuclide radiation therapy system 

892.5770 

892.5840 

Powered radiation therapy patient 
support assembly 
Radiation therapy simulation system 

892.5930 

Therapeutic x-ray tube housing  assembly 

2 

2 

2 

2 

2 

2 

2 

2 

1 

2 

1 

1 

2 

2 

1 

2 

2 

2 

2 

2 

2 

2 

2 

1 

112 

125 

Initialled on 20 June 1997 

US - EC  MRA Medical Devices Annex 

Nuclear 
Medicine 

892.1170 

Bone densitometer 

892.1200 

892.1310 

Emission computed tomography 
system 
Nuclear tomography system 

892.1390 

Radionuclide rebreathing system 

2 

2 

1 

2 

General/Plastic Surgery Panel 

Product Family  Section 

Device Name 

Tier 

No 

Surgical Lamps  878.4630 

890.5500 

Ultraviolet lamp for  dermatologic 
disorders 
Infrared  lamp 

878.4580 

Surgical lamp 

Electrosurgical 
Cutting 
Equipment 

878.4810 

878.4400 

Laser surgical instrument for use in 
general and plastic surgery and in 
dermatology 
Electrosurgical cutting and coagulation 
device and  accessories 

Miscellaneous 

878.4780  Powered suction pump 

2 

2 

2 

2 

2 

2 

113 

126 

Initialled on 20 June  1997 

Financial Statement 1998-2002 

External trade relations - Mutual Recognition  Agreement 

1. TITLE 

External Trade Relations-
Mutual Recognition Agreements with United States, Canada. Australia, New Zealand  and 
Israel. 

2. BUDGETARY  HEADINGS: 

B7-8500 
A-7010 

3. LEGAL BASIS 

•  Article  113 of the Treaty of Rome 
•  Proposal for Council decisions N°.... on the implementation by the European 
Commission of mutual recognition  agreements with United States, Canada, Australia, 
New Zealand  and Israel. 

4. DESCRIPTION OF OPERATION : 

4.1 General  objective: 

The purpose of these agreements is to establish mutual recognition  of certification  of 
conformity  of products with technical regulations or standards of partners to the 
agreement. 

The  major  actions  which  will  be  pursued  by  the  Commission  under  this  budget  line 
will be the  following: 

•  Confidence-building  activities  to  facilitate  the  proper  implementation  of  the 

Agreement. 

•  Management  of  the  Agreements  and  maintenance  of  the  necessary  degree  of 

confidence. 

The  Commission  will  be  assisted  by  experts,  particularly  in  regard  to  sectoral 
activities.  I 
activities.  It  will  however  remain  the  final  arbiter  in  the  management  of  these 
agreements. 

4.2 Duration of the action; means foreseen  for its renewal: 

The  general  action  undertaken  will  be  of  an  indefinite  duration.  The  initial  period  of 
confidence-building  required  by  the  Agreements  will  require  a  more  intensive  effort 
and expenditure, but this should be substantially less after 2 years. However, during  the 
life  of  the  Agreements  a  continued  effort  will  be  needed  to  ensure  management  and 
maintenance of  confidence. 

5. CLASSIFICATION  OF  EXPENDITURE/REVENUE 

5.7 Non-compulsory expenditure ("DNO") 

5.2 Differentiated  appropriation ("CD") 

5.3  Type of revenue involved: 
None 

127 

6. TYPE OF  EXPENDITURE/REVENUE 

-  100% subsidy: No 

-  subsidy for  co-financing with other sources in the public  or private  sector? 

Yes, this may be envisaged  as a method of funding.  Subsidies not normally  exceeding 
50% will be provided to professional  associations  and other responsible  organisations 
for activities related  to the implementation  of the Agreement. 

-  Interest subsidy: No 

-  Others 

Financing of events, acquisition of studies, publications and  conferences. 

-  Should the action prove an economic success, is there provision for  all, or part 

of  the Community contribution to be reimbursed? 

Not relevant 

-  Will the proposed  operation cause any changes in the level of revenue? 

No 

7. FINANCIAL IMPACT ON APPROPRIATIONS  FOR  OPERATIONS 

7.1  Method of calculating the total cost of the operation: 

The  estimation  of  costs  is based  on the  anticipated  requirements  in  terms  of  expenses 
related  to  training,  seminars,  workshops,  travel  of  experts,  verification  of  conformity 
assessment  bodies, information  and  studies.  The  total  estimated  cost  is  based  on  the 
sum of the individual actions. 

A range of different  actions  are foreseen  to meet the  objectives  of the budget-line  and 
costs will vary depending  on the nature of action undertaken.  Even for similar types of 
action  (e.g.  seminars)  costs  will  vary  depending  on  the  scope  of  the  action  and  the 
degree of specialisation  needed. 

The costs of specific  actions will be determined  either: 

•  by the Commission when it organises activities itself, e.g. seminars 
• 
• 

following  invitations to tender issued  by the Commission 
following  requests for subsidies.  In such cases, projects  are selected  according to 
how well they meet the criteria which have been established for  selection. 
Subsidies are based on a percentage of total costs and usually the Community 
funding  is limited  to a maximum of 50%. 

A.  Attendance at Joint Committee 

These  will  be  attended  by  Commission  officials  and  some  national  experts.  Travel 
and per diem expenses should be foreseen  within the normal range of such expenses. 

128 

B.  Attendance at Joint Sectoral Groups 

These will also be attended by Commission officials  and given the nature of these 
meetings a larger contingent of national experts. Travel and per diem expenses 
should  be foreseen  within the normal range of such expenses. 

C.  Workshops and  Seminars 

These will be held  to familiarise  economic and other operators with the  requirements 
of  the  Agreement.  The  cost  of  these  seminars  will  vary  according  to  the  subject 
matter  and  location,  and  will  include  organisational  costs  (when  in  Europe)  and 
substantial  travel  costs  when  in  the  territory  of  the  partner  country.  Organisational 
costs  in  Europe  will  cost  c.  3000  ECUs  each.  The  number  of  seminars  will  vary 
depending on the individual industrial sectors covered by the Agreement. 

D.  Verification  actions 

The  competence  of  the  conformity  assessment  bodies  (CABs)  will  in  many  cases 
have to be checked, more so in the initial period of the Agreement, but as a matter of 
course throughout the life of the Agreement to maintain confidence  in the system. 

This  will  involve  on-site  assessment  by  teams  of  experts  of  conformity  assessment 
bodies  in  the partner  country  in  the  initial  stages,  and  subsequently  investigation  of 
complaints.  This  expenditure  will  be essential  in  all  sectors  of  the Agreement  (...  in 
number)  and  may  involve  numerous  CABs  in each  sector  including  at subfederal  or 
local level in certain cases. 

E.  Production and dissemination  of  information 

Certain costs may need to be incurred for the dissemination  of information.  Guides to 
regulations  and  assessment  procedures  may  be  needed  typically  at  a cost  of  10  000 
ECUs. 

129 

7.2 

Breakdown by elements of the operation 

"Trade Agreements with important Trading Partners" 

For  1998, this involves the following  calculation: 

Budget Heading 

Amounts 
(Ecus) 

Joint Committee 

12 940 

B7-8500 

Sectoral Groups 
B7-8500 

Seminars 

B7-8500 

57 680 

103 540 

Verifications 

; 

142 150 

Method of calculation 

No. of missions 
Bxl 
Bxl 
Aus / NZ 
Israel 

2 
2 
2 
1 

Standard Unit cost 
US:  Travel:  2  000  Ecus; 
per diem:  185 Ecus 

Bxl 
US 
CAN 

US 
CAN 
Aus/NZ 
Bxl 

US 
CAN 
Aus/NZ 
Israel 

16 
8 
8 

10 
10 
14 
28 

18 
18 
12 
1 

CAN:  Travel:  1  750 
Ecus; per diem:  170 Ecus 

Aus  /  NZ:  Travel:  3  200 
Ecus; per diem:  190 Ecus 

Brussels:  Travel:  800 
Ecus; perdiem:  110 Ecus 

B7-8500 

Information 
B7-8500 
B7-8500 

10 000 

Total 

326 310 

150 

In Ecus 
(current prices) 

Breakdown 

Year 
1998 

Year 
1999 

2000 

2001 

2002 

Total 
1998-2002 

A. Joint Committee 

12.940 

13 760 

12 940 

13 760 

12 940 

66 340 

B. Joint Sectoral  Groups 

57 680 

57 680 

57 680 

57 680 

57 680 

288 400 

C. Seminars 

103 540 

96 310 

199 850 

D.  Verifications 

142 150 

142  150 

48 430 

48 430 

48 430 

429 590 

E.  Information 

10 000 

10 000 

10 000 

30 000 

Total 

326 310 

319 900 

129 050 

119 870 

119 050 

1014  180 

From  the year 2000 on the estimates are for  information. 

130 

7.3 

Indication  of the timetable for commitment and payment  appropriations 

Year 
1998 

1999 

2000 

2001 

2002 

1000 Ecus 
2003 
and 
following 
years 

Total 

326 

319 

129 

119 

119 

119 

1131 

Schedule of 
Commitment 
Payment 
appropriations 
1998 
1999 
2000 
2001 
2002 
2003 

326 

319 

129 

119 

119 

326 
319 
129 
119 
119 
119 

1131 

119 

119 

Total 

326 

319 

129 

119 

119 

8. WHAT ANTI-FRAUD MEASURES ARE PLANNED IN THE PROPOSAL FOR 

THE OPERATION ? 

Methods  of  control  (submission  of  reports,  etc.)  will  be  included  in  all  contracts 
between the Commission and  beneficiaries. 

A close cooperation  with  the delegations  of the Commission  and  the participation  of 
a representative  of the Commission  at events in third countries will check on the spot 
the work to ensure that it corresponds  with the terms of reference, contract provisions 
and required  professionalism. 

The checks take place before the final payment. The same rule applies to the financial 
incentives paid to participating companies. Where appropriate, agreements also 
require organisations to submit financial  accounts certified  by their auditors. 

In those eases involving cooperation with EU industrial federations  the accounts are 
further  checked at the Annual General Meeting of the federations  concerned. 

9.  ELEMENTS  OF COST-EFFECTIVENESS  ANALYSIS 

9.1.  Specific  objectives  of the proposed  operation, population targeted 

-  The specific objectives of mutual recognition agreements are: 

• 
• 
• 

to avoid duplication of certification  by economic operators. 
to promote exports, employment, competitivity  and investment. 
to reduce costs, in particular for  small  and medium-sized  enterprises  and  ultimately 
for the consumer. 

-  Target population 

The  target  population  are  the  exporting  companies,  business  associations,  chambers 
of commerce and public institutions of the European Union and the general  consumer 
which will benefit, or have an interest in, the mutual recognition of  certification. 

131 

9.2.  Reasons for the operation 

-  Need for  intervention from  the Community budget 

Under  Article  113 of  the Treaty  of  Rome  the Community  has  exclusive  competence 
for commercial policy and these agreements have been negotiated  in accordance  with 
a  mandate  of the  Council  of  Ministers  and  in  consultation  with  the  113 Committee. 
The  Commission  will  be  responsible  for  implementation  and  management  of  the 
agreements. 

-  Choice of methods of intervention 

* advantages over alternative measures (comparative advantages) 

* analysis of similar operations at Community or national level 

* results and expected multipliers 

The  choice  of  management  method  (Joint  Committee  and  Joint  Sectoral  Groups)  have 
been  set  out  in  the  Agreements  and  constitute  a  minimum  necessary  for  the  proper 
functioning  of  the  Agreement.  The  Agreements  also  contain  provisions  for  the  use  of 
seminars in the initial phases to ensure familiarity  with other systems. 

These  seminars  and  verifications  are  also  designed 
to  build  mutual  confidence; 
verifications  will  also be required  to ensure  this confidence  is  maintained  throughout  the 
life  of  the  agreements.  Confidence  and  its  maintenance  are  keys  to  the  successful 
operation of the agreements. 

The importance of this budget is justified  when put in perspective with the trade involved 
in  these  agreements  and  the  yearly  savings  for  EU  exporters  which  are-  expected 
(estimated  on a yearly basis  at  190 millions  ECUs for  EU exporters to the US, 20 mio in 
the  case  of  exports  to  Canada  and  40  mio  in  the  case  of  exports  to  Australia  and  New 
Zealand). 

-  Main factors  of uncertainty which could affect the specific results of the 

operation. 

* None 

9.3  Monitoring  and evaluation  of the operation 

-  Performance indicators selected 

* Output indicators 

* indicators of impact, following  the objectives chosen 

In the case of these Agreements, success can be quantified  by trade facilitation  through 
avoidance  of  duplication  of  testing  and  certification  and  costs.  Yearly  estimated 
savings for the European Community are indicated  above (9.2). 

Success can also be measured by increased EU exports and this factor  will be taken 
into consideration  although export performance  is subject to such a wide range of 
variables  (e.g. changes in exchange rates) that this can never be the sole factor  for 
evaluation. 

132 

-  Evaluation of results 

Progress  in  the  attainment  of  the  Agreements  objectives  will  be  monitored  by 
Commission  officials,  Committees  established  under  the  Agreements  and  by  the 
economic operators concerned. 

Details and frequency  of the planned evaluation 

The evaluation of the effectiveness  and usefulness  of the agreements wil be regularly 
monitored by the Commission and by the Committees established under the agreements at 
their annual meetings. The first major evaluation will be at the end of the  confidence-
building period. 

10. 

ADMINISTRATIVE  EXPENSES 

Actual  mobilisation  of  the  necessary  administrative  resources  will  depend  on  the 
Commission's  annual  decision  on  the  allocation  of  resources,  taking  into  account  the 
number of staff  and additional amounts authorised  by the budgetary  authority. There is no 
request for  additional  staff. 

10.1  Effect  on the number of posts 

Type of post 

Staff  to be assigned to 
managing the operation 

Permanent 
posts 

Temporary 
posts 

DGI 
+ 
sectoral DGs 
.3.5 

Officials 

A 

B 

C 

Source 

Duration 

Additional 
resources 

Existing 
resources in the 
DGs or 
departments 
concerned 

None 

3.5 

None 

permanent 

Other resources 
Total 

None 

1 

4.5 

1 

4.5 

10.2  Overall financial  impact of human resources: 4.5 staff  (107 500 Ecus per staff 

member per year = 483 750 Ecus). 

10.3 

Increase in other administrative expenditure  as a result of the operation  (A-7010: 
travel expenses) 

The  expenses  set  out  below  relate  to  travel  expenses  for  officials  of  the  Commission 
attending  meetings  of  the  Joint  Committee,  joint  sectoral  groups,  seminars  and 
verifications,  when  these are outside Brussels. These will  be taken  care  of  by the relevant 
budnet allocations of various Directorates Generals  involved. 

133 

For 1998 this involves the following calculation: 

Budget heading 

Amounts  (ECU) 

Method of calculation 

Joint Committee 

A-7010 
Sectoral Groups 

A-7010 
Seminars 

A-7010 
Verifications 

22 120 

20 680 

20 680 

A-7010 

142 150 

A-7010 

Total 

205 630 

No. of missions 
Aus / NZ 
Israel 

4 
4 

Standard Unit cost 
US: Travel: 2 000 ECUs; 
per diem:  185 Ecus 

CAN:  Travel:  1  750 
Ecus; per diem:  170 Ecus 

Aus  /  NZ:  Travel:  3  200 
Ecus; per diem:  190 Ecus 

US 
CAN 

US 
CAN 
Aus / NZ 
US 
CAN 
Aus/NZ 
Israel 

4 
4 

4 
4 

18 
18 
12 
1 
73 

Year 
1998 

Year 
1999 

2000 

2001 

2002 

Total 
1998-2002 

In ECU 

22 120 

20 680 

22 120 

20 680 

22 120 

107 720 

20 680 

20 680 

20 680 

20 680 

20 680 

103 400 

A. Joint 
Committee 
B Joint Sectoral 
Groups 

C. Seminars 

20 680 

18 260 

38 940 

D. Verifications 

142 150 

142 150 

48 430 

48 430 

48 430 

429 590 

TOTAL 

205 630 

201 770 

91230 

89 790 

91230 

679 650 

1 . o  ^ 

IMPACT ASSESSMENT FORM 
THE IMPACT OF THE PROPOSAL ON BUSINESS 
with special reference  to small and medium-sized  enterprises 

Title of  proposal 

Proposal for  a Council Decision  on the conclusion of an Agreement between  the 
European  Community and the United States on Mutual Recognition in relation to 
Conformity  Assessment. 

Reference  number 

The proposal 

The legislation is necessary to conclude an Agreement between the European  Community 
and the United  States on Mutual Recognition in relation to Conformity  Assessment. 
Certificates  and Markings. This is an agreement negotiated and initialled by the 
Commission in accordance with the mandate and negotiating directives provided by the 
Council  on 21/9/92. 

The impact on business 

The business sectors affected  are telecommunications  terminal equipment, electrical 
equipment, recreational craft,  medicinal products, and medical devices. 

The Agreement permits certification  of conformity  with technical regulations on product 
safety, etc, to be conducted in Europe for exports destined for the United States. This 
avoids the necessity for further  certification  by United States conformity  assessment 
bodies  before  putting them oh the United  States market. 

The Agreement therefore presents important advantages from  the point of view of 
transparency, market access, avoidance of duplication especially of cost and general 
facilitation  of trade. This is of particular importance for small and  medium-sized 
enterprises. 

The Agreement covers a wide range of sectors spread throughout the Community and an 
extensive range of firms  in these sectors both large and small, the advantages  are not 
limited  to specific  geographical  areas in the Community. 

Businesses will have to comply with United  States regulations and procedures, but the 
certification,  as stated above, will be conducted  by conformity  assessment bodies located 
in the Community and designated  by the Member States, and not in the United States. 

The Agreement will substantially reduce certification  costs and improve prospects  for 
exports, employment, investment and competitiveness  by European firms. 

The Agreement does not contain measures to take account of the specific  situation of 
small and medium-sized firms, but by its nature and by reducing certification  costs which 
are the same for all firms, the agreement will benefit small and medium sized  enterprises 
to a greater extent proportionately  than larger  firms. 

_L \}  o 

Consultation 

The main trade organisations in each sector eg Eurobit, Orgalime, EFPIA have been 
consulted and have universally declared their support for the Agreement. 

136 

EU  TRADE  WITH  USA  1995  (MECU) 

IMPORT 

lllilHï 

m- H 

Products 

EXPORT 

nm 

• 

Pharmaceuticals 

Medical Devices 

Telephonic & Telegraphic 
Equipment 

1867 

2 966 

2 000 

1.8 

2.9 

1.9 

Pharmaceuticals 

Medical Devices 

Telephonic & 
Telegraphic Equipment 

Electrical Equipment 

14 565 

14.1 

Electrical Equipment 

Recreational Craft 

212 

0.2 

'  Recreational Craft 

2216 

1726 

584 

8 790 

110 

2.1 

1.7 

0.6 

8.5 

0.1 

Total 

21610 

20.9 

Total 

13 426 

13.0 

TOTAL 

103 644 

100.0 

TOTAL 

103 284 

100.0 

EU  TRADE  WITH  USA  1996  (MECU) 

IMPORT 

EXPORT 

WrùÊMim 

Ifll  Hi 

Products 

lisp  m 

Pharmaceuticals 

Medical Devices 

Telephonic & Telegraphic 
Equipment 

2518 

3 509 

2 869 

2.2 

3.1 

2.5 

Pharmaceuticals 

Medical Devices 

Telephonic & 
Telegraphic Equipment 

Electrical Equipment 

15 844 

14.1 

Electrical Equipment 

Recreational Craft 

216 

0.2 

Recreational Craft 

2 593 

1770 

729 

9 793 

138 

2.3 

1.5 

0.6 

8.6 

0.1 

Total 

24 956 

22.2 

Total 

15 024 

13.1 

TOTAL 

112 624 

100.0 

TOTAL 

114 309 

100.0 

SOURCE: 

Pharmaceuticals: (ch 30) 
Medical Devices: (ch 9018, 9019, 9020, 9021, 9022) 
Telephonic  & telegraphic  Equipment:  (ch 8517) 
Electrical Equipment: (ch 85) 
Recreational Craft:  (ch  8903) 

Source: EUROSTAT  (COMEXT) 

Brussels, 29 October  1997 

137 

ISSN 0254-1475 

COM(98) 180 final 

DOCUMENTS 

EN 

11  15  16  03 

Catalogue  number  :  CB-CO-98-194-EN-C 

ISBN 92-78-32511-2 

Office  for Official  Publications of the European  Communities 

L-2985  Luxembourg 

138