Agreement on mutual recognition between the European Community and the United States of America - Joint Declaration
Date: 1998-05-18
Institutions: European Community, United States
Subjects: Community certification, EC conformity marking, United States, agreement (EU), harmonisation of standards, mutual recognition principle, quality label, quality standard, sectoral agreement

4.2.1999

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on  mutual  recognition  between  the  European  Community  and  the  United  States  of  America

AGREEMENT

TABLE  OF  CONTENTS

1.  Framework . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2.  Telecommunication  Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.  Electromagnetic  Compatibility  (EMC)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4.  Electical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5.  Recreational  Craft

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6.  Pharmaceutical  Good  Manufacturing  Practices  (GMPs)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7.  Medical Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Page

4

13

21

27

32

36

49

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The  EUROPEAN  COMMUNITY,  and  THE  UNITED  STATES  OF  AMERICA,  hereinafter  referred  to  as
‘the  Parties’,

CONSIDERING the traditional links of friendship that exist between the United States of America (US) and
the  European  Community  (EC);

DESIRING  to  facilitate  bilateral  trade  between  them;

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

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

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

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

RECOGNISING  that  mutual  recognition  agreements  can  positively  contribute  in  encouraging  greater
international  harmonisation  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;

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;

RECOGNISING  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;

RECOGNISING  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

—  ‘Designation’  means 

a
the 
Designating  Authority  of  a  conformity  assessment
body  to  perform  conformity  assessment  procedures
under  this  Agreement.

identification  by 

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.

—  ‘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.

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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
International
for  Standardisation 
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.

(ISO)  and 

the 

Article  2

Purpose  of  the  Agreement

This  Agreement  specifies  the  conditions  by  which  each
Party  will  accept  or  recognise  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
in  the  Sectoral
specified  on  a  sector-specific  basis 
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

1. The  United  States  shall,  as  specified  in  the  Sectoral
Annexes,  accept  or  recognise  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.

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

legislative, 

specified 

to 

3. 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 utilised assure
conformity to 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.

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 
this
Agreement.

in 

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 regulation 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.

Article  5

Transitional arrangements

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

implement 

the 

to 

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1. The  Parties  agree  that  each  sectoral  transition
arrangement  shall  specify  a  time  period  for  completion.

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

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.

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

that 

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;

(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

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 
the
contestation or to correct the deficiencies which form
the  basis  of  the  contestation;

information 

to  refute 

in  order 

(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 
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;

is  required, 

(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

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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;

assessment 

(f)  Upon the suspension of a conformity assessment body
listed  in  a  Sectoral  Annex,  a  Party  is  no  longer
obligated  to  accept  or  recognise  the  results  of
conformity  assessment  procedures  performed  by  that
conformity 
to
suspension.  A  Party  shall  continue  to  accept  the
results 
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

subsequent 

conformity 

assessment 

body 

of 

instance,  the  Joint  Sectoral  Committee  or  the  Joint
joint
Committee  may  decide 
verification  of 
the
completion  of  such  verification,  the  proposal  for
withdrawal  of  the  conformity  assessment  body  may
be  resubmitted  to  the  other  Party;  and

the  body  concerned.  After 

to  carry  out  a 

(e)  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
environmental
safety 
based  on  health, 
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  10

Monitoring  of  conformity  assessment  bodies

Article  9

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

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;

(d) 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

(a)  Designating  Authorities 

that 

shall  assure 

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
the  Sectoral  Annexes.  Existing
requirements  of 
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;

(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.

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Article  11

Article  14

Conformity  assessment  bodies

Joint  Committee  of  the  Parties

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

the  scope  of 

Article  12

Exchange  of  information

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

legislative, 
identified 

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.

identified 
consult  as  necessary  with 

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

Article  13

Sectoral  contact  points

1. The  Parties  hereby  establish  a  Joint  Committee
consisting  of  representatives  of  each  Party.  The  Joint
Committee  comprised  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 
the  Joint
Committee. The Joint Committee shall make its decisions
by  unanimous  consent.  The  Joint  Committee  shall
determine  its  own  rules  and  procedures.

in 

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
its  Sectoral  Annexes  not
this  Agreement  and 
otherwise  resolved  in  the  respective  Joint  Sectoral
Committees;

(d) providing  a  forum  for  discussion  of  issues  that  may
this

implementation  of 

concerning 

the 

arise 
Agreement;

(e)  considering  ways  to  enhance  the  operation  of  this

Agreement;

(f)  coordinating  the  negotiation  of  additional  Sectoral

Annexes;  and

(g)  considering  whether  to  amend  this  Agreement  or  its
Sectoral  Annexes  in  accordance  with  Article  21.

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

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

1. Nothing in this Agreement shall be construed to limit
the  authority  of  a  Party  to  determine,  through  its

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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.

immediate  measures  whenever 

2. Nothing in this Agreement shall be construed to limit
the  authority  of  a  Regulatory  Authority  to  take  all
appropriate  and 
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 
its
counterpart authority and the other Party within 15 days
of  taking  such  action,  providing  its  reasons.

takes  such  action, 

it  shall 

inform 

Article  16

Suspension  of  recognition  obligations

Either Party may suspend its obligations under a 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  fulfil  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;

Article  17

Confidentiality

1. Each  Party  agrees  to  maintain,  to  the  extent  required
under 
information
exchanged  under  this  Agreement.

the  confidentiality  of 

laws, 

its 

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  unauthorised  disclosure.

Article  18

Fees

Each  Party  shall  endeavour  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.

Article  20

Territorial application

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

This  Agreement  shall  apply,  on  the  one  hand,  to  the
territories  in  which  the  Treaty  establishing  the  European

L  31/10

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4.2.1999

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

Equipment, 

1. This  Agreement  including  its  Sectoral  Annexes  on
Telecommunication 
Electromagnetic
Compatibility,  Electrical  Safety,  Recreational  Craft,
Pharmaceutical  Good  Manufacturing  Practices  (GMPs),
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  from  the  date  of
notice.

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.

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  original  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.

4.2.1999

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L  31/11

Hecho  en  Londres,  el  dieciocho  de  mayo  de  mil  novecientos  noventa  y  ocho.

Udfærdiget  i  London  den  attende  maj  nitten  hundrede  og  otteoghalvfems.

Geschehen  zu  London  am  achtzehnten  Mai  neunzehnhundertachtundneunzig.

˛γØν(cid:229)  (cid:243)(cid:244)(cid:239)  Λ(cid:239)ν(cid:228)(cid:221)ν(cid:239),  (cid:243)(cid:244)Øς  (cid:228)(cid:229)(cid:139) κÆ  (cid:239)κ(cid:244)ω(cid:139) ΜÆØ(cid:239)υ  ł(cid:221)λØÆ  (cid:229)ννØÆκ(cid:222)(cid:243)ØÆ  (cid:229)ν(cid:229)νη(cid:139) ν(cid:244)Æ  (cid:239)κ(cid:244)ω(cid:139) .

Done  at  London  on  the  eighteenth  day  of  May  in  the  year  one  thousand  nine  hundred  and
ninety-eight.

Fait  à  Londres,  le  dix-huit  mai  mil  neuf  cent  quatre-vingt-dix-huit.

Fatto  a  Londra,  addì  diciotto  maggio  millenovecentonovantotto.

Gedaan  te  Londen,  de  achttiende  mei  negentienhonderd  achtennegentig.

Feito  em  Londres,  em  dezoito  de  Maio  de  mil  novecentos  e  noventa  e  oito.

Tehty 
kahdeksantenatoista 
tuhatyhdeksänsataayhdeksänkymmentäkahdeksan.

Lontoossa 

päivänä 

toukokuuta 

vuonna

Som  skedde  i  London  den  artonde  maj  nittonhundranittioåtta.

Por  la  Comunidad  Europea

For  Det  Europæiske  Fællesskab

Für  die  Europäische  Gemeinschaft

ΓØÆ  (cid:244)ην  Ευρω(cid:240)Æϊκη(cid:139) Κ(cid:239)Øν(cid:222)(cid:244)η(cid:244)Æ

For  the  European  Community

Pour  la  Communaute´ europe´enne

Per  la  Comunità  europea

Voor  de  Europese  Gemeenschap

Pela  Comunidade  Europeia

Euroopan  yhteisön  puolesta

På  Europeiska  gemenskapens  vägnar

L  31/12

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4.2.1999

Por  los  Estados  Unidos  de  Ame´rica

For  Amerikas  Forenede  Stater

Für  die  Vereinigten  Staaten  von  Amerika

ΓØÆ  (cid:244)Øς  Ηνωµ(cid:229)(cid:139) ν(cid:229)ς  Π(cid:239)λØ(cid:244)(cid:229)(cid:221)(cid:229)ς  (cid:244)ης  Αµ(cid:229)ρØκη(cid:139) ς

For  the  United  States  of  America

Pour  les  États-Unis  d’Ame´rique

Per  gli  Stati  Uniti  d’America

Voor  de  Verenigde  Staten  van  Amerika

Pelos  Estados  Unidos  da  Ame´rica

Amerikan  yhdysvaltojen  puolesta

På  Amerikas  förenta  staternas  vägnar

4.2.1999

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L  31/13

SECTORAL  ANNEX  FOR  TELECOMMUNICATION  EQUIPMENT

PREAMBLE

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

SECTION I

LEGISLATIVE,  REGULATORY  AND  ADMINISTRATIVE  PROVISIONS

EC

USA

Directive 98/13/EC of the European Parliament and
of  the  Council  of  12  February  1998  relating  to
telecommunications terminal equipment and satellite
earth  station  equipment, 
including  the  mutual
recognition  of  their  conformity,  and  interpretation
thereof;

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

The  US  regulatory  and  administrative  provisions  in
respect  of  telecommunication  equipment,  including
47  CFR  Part  68,  and  FCC  interpretation  thereof;

(The  Parties  recognize  that  the  Handbook  on  the
implementation of Directive 98/13/EC (ADLNB and
ACTE  approved),  provides  useful  guidelines  for  the
implementation 
assessment
of 
procedures  falling  under  this  Directive.);

conformity 

Commission  Decisions  (CTRs)  established  under
Directive  98/13/EC;

The  EC  Member  States’  legislation  and  regulations
in  respect  of:
(a)  non-harmonised  analogue  connection  to  the

public  telecommunications  network (1);

(b) non-harmonised  radio  transmitters  for  which
is  a  civilian  equipment  authorisation

there 
requirement;

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

conformity 
telecommunication 

for 

of 

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

authorisation 

requirement. 

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

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

For  electromagnetic  compatibility  aspects, 
Electromagnetic  Compatibility 
Annex  to  the  Agreement.

see
(EMC)  Sectoral

For  electromagnetic  compatibility  aspects, 
Electromagnetic  Compatibility 
Annex  to  the  Agreement.

see
(EMC)  Sectoral

(1)  The  EC  agrees  to  seek  authority  to  include  non-harmonised  digital  connections;

L  31/14

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4.2.1999

SECTION II

SCOPE  AND  COVERAGE

1.  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  telecommunication
terminal  equipment,  satellite  terminal  equipment,  radio  transmitters,  and  information  technology
equipment:

(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  authorisation  procedure  by  either  Party.

2.  The following is a non-exclusive list of the equipment, interfaces, and services included within the scope

of  this  Sectoral  Annex:

EC

USA

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  kbit/s  unstructured

—  2048  kbit/s  structured

—  34  Mbits/s  access

—  140  Mbits/s  access

—  2  wire  analogue

—  4  wire  analogue

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-wire  analog  tie  trunks/ops

4-wire  analog  tie  trunks/ops

PSTN  Voice  Band  (Analog)  Access

Private  Line  (Analog)  Access

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L  31/15

EC

USA

Radio 
authorisation  requirement,  including:

transmitters 

subject 

to  an  equipment

Radio 
authorisation  requirement,  including:

transmitters 

subject 

to  an  equipment

—  Short range devices, including low power devices

Commercial  Mobile  Radio 

such  as  cordless  telephones/microphones;

—  Land  mobile,  including:

—  Private  Mobile  Radio  (PMR/PAMR)

—  Mobile  telecom

—  Paging systems

—  Terrestrial  fixed

—  Satellite mobile

—  Satellite  fixed

—  Broadcast

—  Radio  determination

Domestic  Public  Fixed 

Domestic  Mobile 

Personal  Communication
Service 

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 

(Part  20)

(Part  21)

(Part  22)

(Part  24)

(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)

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

Fixed  Microwave  Services 

(Part  101)

CONFORMITY  ASSESSMENT  PROCEDURES  FOR  TELECOMMUNICATION  EQUIPMENT

SECTION III

1.  Description  of  Mutual  Recognition  Obligations

In accordance with the provisions of the Agreement, the result of the conformity assessment procedures
produced  by  a  Party’s  conformity  assessment  bodies  listed  in  Section  V  shall  be  recognised  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  recognises  that  the  conformity  assessment  bodies  of  the  other  Party,  listed  in  Section  V,  are
authorised  to  perform  the  following  procedures  with  regard  to  the  importing  Party’s  technical
requirements  for  telecommunication  terminal,  satellite  terminal  equipment,  radio  transmitters  or
information  technology  equipment:

(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;  and

(c)  performing  quality  assurance  certification  pursuant  to  Directive  98/13/EC.

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4.2.1999

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

SECTION  IV

EC

USA

National  Institute  of  Standards  and  Technology
(NIST)

Federal  Communications  Commission  (FCC)

—  Belgium

Institut  belge  des  services  postaux  et  des
te´le´communications
Belgisch 
instituut 
telecommunicatie

postdiensten 

voor 

en

—  Denmark

Telestyrelsen

—  Germany

Bundesministerium  für  Wirtschaft

—  Greece

Υ(cid:240)(cid:239)υργ(cid:229)(cid:221)(cid:239)  Μ(cid:229)(cid:244)Æ(cid:230)(cid:239)ρω(cid:139) ν  κÆØ  Ε(cid:240)Øκ(cid:239)ØνωνØω(cid:139) ν
Ministry  of  Transport  and  Communications

—  Spain

Ministerio  de  Fomento

—  France

Ministe`re  de  l’e´conomie,  des  finances  et  de
l’industrie

—  Ireland

Department  of  Transport,  Energy  and
Communications

—  Italy

Ministero  delle  Communicazioni  —  DGROS  e
ISETI  (Radiotransmettitori)

—  Luxembourg

Administration  des  Postes  et  Te´le´communi-
cations

—  Netherlands

De  Minister  van  Verkeer  en  Waterstaat

—  Austria

Bundesministerium  für  Wissenschaft  und
Verkehr

—  Portugal

Instituto  das  Communicações  de  Portugal

—  Finland

Liikenneministeriö/Trafikministeriet
Telehallintokeskus/Teleförvaltningscentralen

—  Sweden

Under  the  authority  of  the  Government  of
Sweden:
Styrelsen  för  ackreditering  och  teknisk  kontroll
(SWEDAC)

—  United  Kingdom

Department  of  Trade  and  Industry

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SECTION  V

CONFORMITY  ASSESSMENT  BODIES

EC  access  to  the  US  market

US  access  to  the  EC  market

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  US
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)

(to  be  provided  by  the  US)

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

SECTION  VI

EC  access  to  the  US  market

US  access  to  the  EC  market

identified 

in  Section 

EC  Authorities 
IV  shall
designate  conformity  assessment  bodies  located  in
the  EC  in  accordance  with  the  US  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,  65,  etc.)  or  the  comparable  EN-45000
Series Standards.

identified 

in  Section 

US  Authorities 
IV  shall
designate  conformity  assessment  bodies  located  in
the  US  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.  22,  25,  28,  58,
61,  62,  65,  etc.)

for  designating, 

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

and  monitoring 

listed 

a 

for  designating, 

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

and  monitoring 

listed 

a 

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  labelling  and
numbering  requirements.  The  assignment  of  the  numbers  may  take  place  in  the  territory  of  the

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exporting  Party.  The  numbers  will  be  allocated  by  the  importing  Party.  Numbering  and  labelling
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, labelled
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
favourable  manner  than  for  like  domestic  goods.

3. 

Joint  Sectoral  Committee

3.1.  A combined Joint Sectoral Committee for this Sectoral Annex and the Electromagnetic Compatibility
(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.

3.2.  The  JSC  consists  of  representatives  of  the  US  and  the  EC  for  telecommunications  and  EMC.  JSC
representatives  may  each  invite  manufacturers  and  other  entities  as  deemed  necessary.  The
representatives  for  the  US  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  US  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.

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

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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;

(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:

(a)  on  receipt  of  tests  reports,  related  documents  and  a  first  evaluation  of  conformity,  the  dossiers  are

promptly  examined  for  completeness;

(b) the  applicant  is  informed  in  a  precise  and  complete  manner  of  any  deficiency;

(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.

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  US  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

ACTE

ADLNB

Approvals  Committee  for  Terminal  Equipment

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  Europe´enne  (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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SECTORAL  ANNEX  FOR  ELECTROMAGNETIC  COMPATIBILITY  (EMC)

PREAMBLE

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

SECTION I

LEGISLATIVE,  REGULATORY  AND  ADMINISTRATIVE  PROVISIONS

EC

USA

Council  Directive  89/336/EEC,  as  amended  by
Council  Directive  92/31/EEC, 
and  Directive
98/13/EC  of  the  European  Parliament  and  of  the
Council  and  interpretation  thereof.

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

The  US  regulatory  and  administrative  provisions  in
respect  of  equipment  subject  to  electromagnetic
requirements including:
—  47  CFR  Part  15
—  47  CFR  Part  18,
and  FCC  interpretation  thereof.

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

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

telecommunication 

For 
transmitters, 
Equipment  Sectoral  Annex  to  the  Agreement.

radio
Telecommunication

equipment  and 

also 

see 

telecommunication 

For 
transmitters, 
Equipment  Sectoral  Annex  to  the  Agreement.

radio
Telecommunication

equipment  and 

also 

see 

SECTION II

SCOPE  AND  COVERAGE

US  access  to  the  EC  market

EC  access  to  the  US  market

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

Any  products  falling  under  the  scope  of  47  CFR
Part  15  and  18.

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CONFORMITY  ASSESSMENT  PROCEDURES  FOR  EQUIPMENT  IDENTIFIED  IN  SECTION  II

SECTION III

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  recognised  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  recognises  that  the  conformity  assessment  bodies  of  the  other  Party,  listed  in  Section  V,  are
authorised  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  the  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.

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

SECTION  IV

EC

USA

National Institute for Standards and Technology
(NIST)

Federal  Communications  Commission  (FCC)

Federal  Aviation  Administration  (FAA)

—  Belgium

Ministe`re  des  Affaires  Economiques
Ministerie  van  Economische  Zaken

—  Denmark

for  telecommunication  equipment:
Telestyrelsen
for  other  equipment:
Danmarks  Elektriske  Materielkontrol
(DEMKO)

—  Germany

Bundesministerium  für  Wirtschaft

—  Greece

Υ(cid:240)(cid:239)υργ(cid:229)(cid:221)(cid:239)  Μ(cid:229)(cid:244)Æ(cid:230)(cid:239)ρω(cid:139) ν  κÆØ  Ε(cid:240)Øκ(cid:239)ØνωνØω(cid:139) ν
Ministry  of  Transport  and  Communications

—  Spain

for  telecommunication  equipment:
Ministerio  de  Fomento
for  other  equipment:
Ministerio  de  Industria  y  Energía

—  France

Ministe`re  de  l’e´conomie,  des  finances  et  de
l’industrie

—  Ireland

Department  of  Transport,  Energy  and
Communications

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EC

USA

—  Italy

Ministero  dell’Industria,  del  Commercio  e
dell’Artigianato

—  Luxembourg

Ministe`re  des  Transports

—  Netherlands

De  Minister  van  Verkeer  en  Waterstaat

—  Austria

for  telecommunication  equipment:
Bundesministerium  für  Wissenschaft  und
Verkehr
for  other  equipment:
Bundesministerium  für  wirtschaftliche
Angelegenheiten

—  Portugal

Instituto  das  Comunicações  de  Portugal

—  Finland

for  telecommunication  equipment:
Liikenneministeriö/Trafikministeriet
for  other  equipment:
Kauppa-  ja  teollisuusministeriö/Handels-  och
industriministeriet

—  Sweden

Under  the  authority  of  the  Government  of
Sweden:
Styrelsen  för  ackreditering  och  teknisk  kontroll
(SWEDAC)

—  United  Kingdom

Department  of  Trade  and  Industry

SECTION  V

CONFORMITY  ASSESSMENT  BODIES

EC  access  to  the  US  market

US  access  to  the  EC  market

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  US
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)

(to  be  provided  by  the  US)

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

SECTION  VI

EC  access  to  the  US  market

US  access  to  the  EC  market

identified 

in  Section 

EC  Authorities 
IV  shall
designate  conformity  assessment  bodies  located  in
the  EC  in  accordance  with  the  US  legislative,
regulatory,  and  administrative  provisions  identified
in  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.

identified 

in  Section 

US  Authorities 
IV  shall
designate  conformity  assessment  bodies  located  in
the  US  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.).

for  designating, 

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

and  monitoring 

listed 

a 

for  designating, 

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

and  monitoring 

listed 

a 

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  Directive  93/465/EEC.

1.2.  The  conformity  assessment  bodies  shall  record  and  retain  details  of  its  investigation  of  the
competence  and  compliance  of  its  sub-contractors  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  conformity  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

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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.

3.2.  The  JSC  consists  of  representatives  of  the  US  and  the  EC  for  telecommunications  and  EMC.  JSC
representatives  may  each  invite  manufacturers  and  other  entities  as  deemed  necessary.  The
representatives  for  the  US  shall  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  US  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)  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;

(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.

SECTION  VIII

TRANSITIONAL  ARRANGEMENT

1.  There  shall  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;

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(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:

(a)  on  receipt  of  test  reports,  related  documents  and  a  first  evaluation  of  conformity,  the  dossiers  are

promptly  examined  for  completeness;

(b) the  applicant  is  informed  in  a  precise  and  complete  manner  of  any  deficiency;

(c)  any  request  for  additional  information  is  limited  to  omissions,  inconsistencies  or  variances  from  the

technical  regulations  or  standards;

(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.

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  US  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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SECTORAL  ANNEX  FOR  ELECTRICAL  SAFETY

PREAMBLE

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

SECTION I

LEGISLATIVE,  REGULATORY  AND  ADMINISTRATIVE  PROVISIONS

US  access  to  the  EC  market

EC  access  to  the  US  market

Council  Directive  73/23/EEC  of  19  February  1973
as  amended  by  Directive  98/13/EC  of  the  European
Parliament  and  of  the  Council.

29  USC  651  et  seq.  US  29  CFR  1910.7

Products  that  are  certified  or  approved  under  the
Federal Mine Safety and Health Act (30 USC 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.

Occupational  Safety  and  Health  Administration
(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
Electromagnetic  Compatibility 
(EMC)  Sectoral
Annex  to  this  Agreement.

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

telecommunication 

For 
the
Telecommunication  Equipment  Sectoral  Annex  to
this  Agreement.

equipment, 

see 

telecommunication 

For 
the
Telecommunication  Equipment  Sectoral  Annex  to
this  Agreement.

equipment, 

see 

SECTION II

SCOPE  AND  COVERAGE

US  access  to  the  EC  market

EC  access  to  the  US  market

The electrical safety requirements of products falling
under  the  scope  of  Council  Directive  73/23/EEC  on
the harmonisation of the laws of the Member States
relating  to  electrical  equipment  designed  or  use
within  certain  voltage  limits.

The electrical safety requirements of products falling
under  the  scope  of  29  CFR  1910  subpart  S.  This
includes  the  electrical  safety  aspects  for  workplace
safety of medical equipment and telecommunication
terminal  equipment  within  the  scope  of  those
Sectoral Annexes.

Products  that  are  certified  or  approved  under  the
Federal Mine Safety and Health Act (30 USC 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  recognised  to  test,  certify  and  mark  products  within  the  scope  of  their  Nationally
Recognised  Testing  Laboratory  (NRTL)  recognition  for  assessing  conformity  to  US  requirements.

With  regard  to  US  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  US  shall  be  recognised  under  Article  11  of
Council  Directive  73/23/EEC  as  ‘bodies  which  may  make  a  report  in  accordance  with  Article  8.’

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

SECTION  IV

EC  access  to  the  US  market

US  access  to  the  EC  market

National Institute for Standards and Technology
(NIST)

—  Belgium

Ministe`re  des  Affaires  Economiques
Ministerie  van  Economische  Zaken

—  Denmark

Bygge- og Boligstyrelsen
Danmarks  Elektriske  Materielkontrol
(DEMKO)

—  Germany

Bundesministerium  für  Arbeit  und
Sozialordnung

—  Greece

Υ(cid:240)(cid:239)υργ(cid:229)(cid:221)(cid:239)  Αν(cid:192)(cid:240)(cid:244)υŒης
Ministry  of  Development

—  Spain

Ministerio  de  Industria  y  Energía

—  France

Ministe`re  de  l’e´conomie,  des  finances  et  de
l’industrie

—  Ireland

Department  of  Enterprise  and  Employment

—  Italy

Ministero  dell’Industria,  del  Commercio  e
dell’Artigianato

—  Luxembourg

Ministe`re  des  Transports

—  Netherlands

De  Minister  van  Volksgezondheid,  Welzijn  en
Sport

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EC  access  to  the  US  market

US  access  to  the  EC  market

—  Austria

Bundesministerium  für  wirtschaftliche
Angelegenheiten

—  Portugal

Under  the  authority  of  the  Government  of
Portugal:
Instituto  Portugueˆs  da  Qualidade

—  Finland

Kauppa- 
industriministeriet

ja  teollisuusministeriö/Handels-  och

—  Sweden

Under  the  authority  of  the  Government  of
Sweden:
Styrelsen  för  ackreditering  och  teknisk  kontroll
(SWEDAC)

—  United  Kingdom

Department  of  Trade  and  Industry

SECTION  V

CONFORMITY  ASSESSMENT  BODIES

EC  access  to  the  US  market

US  access  to  the  EC  market

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

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

(to  the  provided  by  the  EC)

(to  be  provided  by  the  U.S.)

DESIGNATING,  LISTING,  SUSPENDING  AND  WITHDRAWING  CONFORMITY  ASSESSMENT  BODIES

SECTION  VI

EC  access  to  the  US  market

US  access  to  the  EC  market

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

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

Conformance  with  the  appropriate  ISO/IEC  Guides
or  the  corresponding  EN-45000  series  of  standards
shall  be  deemed  consistent  with  US  requirements
identified  in  Section  I.

Conformance with the appropriate EN-45000 series
of  standards  or  the  corresponding  ISO/IEC  Guides
shall be deemed consistent with the requirements of
Council  Directive  73/23/EEC.

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EC  access  to  the  US  market

US  access  to  the  EC  market

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 US 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.

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

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

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

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 
recognition  of  conformity
assessment  bodies  and  confirm  such  a  recognition
by  listing  them  in  Section  V  of  this  Sectoral
Annex.

the 

Upon  receipt  of  a  complete  proposal,  the  US
exercising  its  authority  under  its  law  shall:

in 

operational 

phase 
Equipment 

(a)  prior  to  the  passage  from  the  transitional  phase
the
into 
the 
Telecommunication 
and
Electromagnetic  Compatibility  (EMC)  Sectoral
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;

in 

Equipment 

the  operational  phase 

(b) subsequent  to  passage  from  the  transitional
the
phase 
into 
and
Telecommunication 
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 

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.

supersede 

shall 

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

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

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EC  access  to  the  US  market

US  access  to  the  EC  market

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
procedures  under  its  applicable  domestic  law.

accordance  with 

recognition 

in 

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.

SECTION  VII

JOINT  SECTORAL  COMMITTEE  FOR  ELECTRICAL  SAFETY

1.  The Joint Sectoral Committee for Electrical Safety (JSC/ES) consists of representatives of the US and the
EC.  OSHA  shall  represent  the  US  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.

2.  The Joint 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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SECTORAL  ANNEX  FOR  RECREATIONAL  CRAFT

PREAMBLE

This  Annex  constitutes  a  Sectoral  Annex  to  the  Agreement  on  Mutual  Recognition  between  the  United
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 18 months is arranged to build confidence as defined in
this  Sectoral  Annex,  Section  VI.

LEGISLATIVE,  REGULATORY,  AND  ADMINISTRATIVE  REQUIREMENTS

SECTION I

1.  For  the  European  Community:

Directive  94/25/EC  of  the  European  Parliament  and  of  the  Council  of  16  June  1994  on  the
approximation  of  the  laws,  regulations,  and  administrative  provisions  of  the  Member  States  relating  to
recreational craft.

2.  For  the  US:

46  USC  Chapter  43,  33  CFR  81,  84,  159,  179,  181,  183  and  46  CFR  58.

SECTION II

SCOPE  AND  COVERAGE

1.  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.

2.  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/EC;

(b) for  the  United  States:

Any product falling under the scope of 46 USC Chapter 43, 33 CFR 81, 84, 159, 179, 181, 183 and
46  CFR  58.

3.  The  Parties  agree  that  for  mutual  recognition  to  operate  under  this  Sectoral  Annex,  the  following

arrangements  shall  apply:

(a)  for  approvals  to  European  Community  requirements,  conformity  assessment  bodies  designated  by
the  US  shall  establish  compliance  as  required  to  be  demonstrated  by  Directive  94/25/EC.  This
demonstration  of  compliance  shall  be  recognised  in  the  European  Community  and  products  so
certified  shall  have  unrestricted  access  to  the  EC  market  for  sale  as  recreational  craft,  pursuant  to
Section  I;

(b) 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  US
market  for  sale  as  recreational  craft,  pursuant  to  Section  I.

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AUTHORITIES  RESPONSIBLE  FOR  DESIGNATING  THE  CONFORMITY  ASSESSMENT  BODIES

SECTION III

EC  access  to  the  US  market

US  access  to  the  EC  market

—  Belgium

des  Communications 

Ministe`re 
l’infrastructure
Ministerie  van  Verkeer  en  Infrastructuur

et 

National  Institute  for  Standards  and  Technology
(NIST)

de

—  Germany

Bundesministerium  für  Wirtschaft

—  Spain

Ministerio  de  Fomento

—  France

Ministe`re  de  l’Equipment,  des  Transports  et  du
Logement

—  Italy

Ministero  dell’Industria,  del  Commercio  e
dell’Artigianato

—  Netherlands

De  Minister  van  Verkeer  en  Waterstaat

—  Finland

Merenkulkuhallitus/sjöfartsstyrelsen

—  Sweden

Under  the  authority  of  the  Government  of
Sweden:
Styrelsen  för  ackreditering  och  teknisk  kontroll
(SWEDAC)

—  United  Kingdom

Department  of  Trade  and  Industry

DESIGNATING,  LISTING,  SUSPENDING  AND  WITHDRAWING  CONFORMITY  ASSESSMENT  BODIES

SECTION  IV

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  set  out  in  Section  V  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)  for  the  European  Community,  bodies  which  are  Notified  Bodies  in  accordance  with  Directive

94/25/EC,  are  deemed  to  be  in  compliance  with  US  requirements;

(b) for  the  US,  in  accordance  with  the  requirements  set  out  in  the  regulations  listed  in  Section  I,  the
conformity  assessment  bodies  listed  in  Section  V  are  designated  by  NIST  using  the  evaluation
procedures contained in the appropriate EN-45000 series of standards or the corresponding ISO/IEC
Guides.

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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.

SECTION  V

CONFORMITY  ASSESSMENT  BODIES

EC  access  to  the  US  market

US  access  to  the  EC  market

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

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

(to  be  provided  by  EC)

(to  be  provided  by  the  US)

SECTION  VI

TRANSITIONAL  ARRANGEMENT

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

2.  The purpose of the transitional arrangement is to provide a mean whereby the Parties to this Agreement
can cooperate to establish a system for designating conformity assessment bodies and can mutually build
confidence  in  the  abilities  of  these  bodies.  Successful  completion  of  this  transitional  arrangement  is
intended  to  result  in  a  determination  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.

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,  legislative  and  regulatory  changes  necessary  for  the

provisions  of  this  Annex.

4.  Product  Scope

All  products  covered  by  Section  II  of  this  Annex.

5.  Cooperation

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

6.  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.

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SECTION  VII

ADDITIONAL  PROVISIONS

1.  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.

2.  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  VIII

DEFINITIONS

‘Notified  Body’  means  a  third  party  authorised  to  perform  the  conformity  assessment  tasks  specified  in
Directive  94/25/EC,  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/EC  and  has  been  notified  to  the  Commission  and  to  the  other  Member  States.

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SECTORAL  ANNEX  FOR  PHARMACEUTICAL  GOOD  MANUFACTURING  PRACTICES  (GMPs)

PREAMBLE

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

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 law,
regulations,  standards  and  commitments  made  as  part  of  the  approval  to  market  a  product.

3.

‘Good  Manufacturing  Practices’  (GMPs):  (The  US  and  EC  have  agreed  to  revisit  these  concepts)

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
possess.

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
Authorisation/Product  Authorisation  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.

‘Inspection  Report’  means  the  written  observations  and  Good  Manufacturing  Practices  compliance

5.
assessment  completed  by  an  authority  listed  in  Appendix  2.

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.

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  (GMPs)  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.

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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
GMPs  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  EC)  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  Biologics  Evaluation  and  Research  as  devices  are  not  covered  under  this
Annex.

Appendix  3  contains  an  indicative  list  of  products  covered  by  this  Annex.

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

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

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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  faith  efforts  to  complete
equivalence  assessment  as  expeditiously  as  possible  to  the  extent  the  resources  of  the  authorities  allow.

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).

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  currently  listed  as  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.

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In  addition,  when  an  authority  is  not  listed  as  equivalent  based  on  adequate  experience  gained  during  the
transition  period,  the  Food  and  Drug  Administration  (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.

In  the  EC,  the  qualified  person  will  be  relieved  of  responsibility  for  carrying  out  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)  issued  by  the  manufacturer  certifying
that  the  product  complies  with  requirements  of  the  marketing  authorisation  and  signed  by  the  person
responsible  for  releasing  the  batch/lot.

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 
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  endeavour  to  respond  to  requests  for
clarification  in  a  timely  manner.

indications  of  material 

include 

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  within  90  calendar  days  of  the  request.

Article  14

Transmission  of  pre-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  issued  to  be  addressed  during  the  inspection.  A  shorter
time  may  be  necessary  in  exceptional  cases  and  these  will  be  described  in  the  request.

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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
endorse  normally  the  inspection  reports  of  the  suspended  authority.  A  Party  shall  continue  to  endorse
normally  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.

CHAPTER  5

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  U.S.  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.

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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.

Article  19

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  recognises  that  the  importing  country  has  a  right  to  fulfil  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  28  September  1981  on  the  approximation  of  the  laws  of  the  Member
States  relating  to  veterinary  medicinal  products,  as  widened  and  amended.

Council  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  (EEC)  No  2309/93  of  22  July  1993  laying  down  Community  procedures  for  the
authorisation  and  supervision  of  medicinal  products  for  human  and  veterinary  use  and  establishing  a
European  Agency  for  the  Evaluation  of  Medicinal  Products.

Council  Directive  92/25/EEC  of  31  March  1992  on  the  wholesale  distribution  of  medicinal  products  for
human  use.

Guide  to  Good  Distribution  Practice  (94/C  63/03).

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:

BELGIUM

Inspection  ge´ne´rale  de  la  Pharmacie

Algemene  Farmaceutische  Inspectie

DENMARK

Lægemiddelstyrelsen

GERMANY

Bundesministerium  für  Gesundheit

GREECE

ΕθνØκ(cid:222)ς  ˆργÆνØ(cid:243)µ(cid:222)ς  ΦÆρµ(cid:192)κ(cid:239)υ

Ministry  of  Health  and  Welfare

National  Drug  Organization  (E.O.F)

SPAIN

for  medicinal  products  for  human  use:

Ministerio  de  Sanidad  y  Consumo

Subdirección  General  de  Control  Farmace´utico

for  medicinal  products  for  veterinary  use:

Ministerio  de  Agricultura,  Pesca  y  Alimentación  (MAPA)

Dirección  General  de  la  Producción  Agraria

FRANCE

for  medicinal  products  for  human  use:

Agence  du  Me´dicament

for  veterinary  medicinal  products:

Agence  Nationale  du  Me´dicament  Ve´te´rinaire

IRELAND

Irish  Medicines  Board

ITALY

for  medicinal  products  for  human  use:

Ministero  della  Sanità

Dipartimento  Farmaci  e  Farmacovigilanza

for  medicinal  products  for  veterinary  use:

Ministero  della  Sanità

Dipartimento  alimenti  e  nutrizione  e  sanità  pubblica  veterinaria  —  Div.  IX

LUXEMBOURG

Division  de  la  Pharmacie  et  des  Me´dicaments

NETHERLANDS

Staat  der  Nederlanden

AUSTRIA

Bundesministerium  für  Arbeit,  Gesundheit  und  Soziales

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PORTUGAL

for  human  and  veterinary  (non-immunologicals):

Instituto  da  Farmácia  e  do  Medicamento  —  INFARMED

for veterinary immunologicals:

Direcção  —  Geral  de  Veterinaria

FINLAND

Lääkelaitos/Läkemedelsverket

(National  Agency  for  Medicines)

SWEDEN

Läkemedelsverket  —  Medical  Products  Agency

UNITED  KINGDOM

for  human  and  veterinary  (non-immunologicals):

Medicines  Control  Agency

for veterinary immunologicals:

Veterinary  Medicines  Directorate

EUROPEAN
COMMUNITY

Commission  of  the  European  Communities

European  Agency  for  the  Evaluation  of  Medicinal  Products  (EMEA)

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Appendix  3

Indicative  list  of  Products  covered  by  the  Sectoral  Annex

Recognising  that  precise  definitions  of  medicinal  products  and  drugs  are  to  be  found  in  the  legislation
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  ingredients  or  bulk  pharmaceuticals  (US)/starting

materials  (EC).

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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  and  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  pre-inspection  preparation,  including  appropriate  expertise  of  investigator/team,  review

of  firm/product  and  databases,  and  availability  of  appropriate  inspection  equipment.

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  authorisations/approved

applications.

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VII.  Additional  specific  criteria  for  pre-approval  inspections

A.  Satisfactory  demonstration  through  a  jointly  developed  and  administered  training  program  and

joint  inspections  to  assess  the  authorities’  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  access  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-way  Alert  System

1.  Documentation

—  Defintion  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  E14  4HB,
England.
Telephone  +44-  171-  418 8400,
Fax  418 8416.

for  the  United  States:

(to  be  provided  by  the  U.S.)

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SECTORAL  ANNEX  ON  MEDICAL  DEVICES

PREAMBLE

This  Annex  constitutes  a  Sectoral  Annex  to  the  Agreement  on  Mutual  Recognition  in  Regulation  to
Conformity  Assessment  between  the  United  States  and  the  European  Community.

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.

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  programmes  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  Food  and  Drug  Administration  (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  US  system,  surveillance/post-market  and  initial/pre-approval  inspection  reports;

(b) under  the  US  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  US  regulatory  requirements  in  a  manner  equivalent  to  those
conducted by FDA; and CABs in the US 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  —  US-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  US  and  EC  law  as  medical  devices.

2.  Product  Evaluation  —  US-type  premarket  (510(k))  product  evaluation  reports  and  EC-type-testing
reports  will  be  exchanged  only  with  regard  to  those  products  classified  under  the  US  system  as  Class
I/Class  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  US  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  Authorities

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.

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  programme  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.

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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  US  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.

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  16.

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

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.

Article  11

Exchange  and  endorsement  of  quality  system  evaluation  reports

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  reports;  and

(b) for  surveillance  quality  system  evaluations,  EC  CABs  will  provide  abbreviated  reports.

2. Listed  US  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.

If  the  abbreviated  reports  do  not  provide  sufficient  information,  the  importing  Party  may  request

3.
additional  clarification  from  the  CAB.

4. 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  endeavour  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  US  medical  device  requirements.

2. US 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.

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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 other specific evidence of
serious concern in relation to product safety, performance, or quality. In such cases, the importing Party my
request  clarification  from  the  exporting  Party  which  may  lead  to  a  request  for  a  re-evaluation.  The  parties
will  endeavour  to  respond  to  requests  for  clarification  in  timely  manner.  Endorsement  remains  the
responsibility  of  the  importing  Party.

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 inspection, for cause, identified to the other Party. If the exporting Party cannot perform
an  inspection  within  a  specified  period  time,  the  importing  Party  may  perform  an  inspection  on  its  own.

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 period, 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  Articles  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  SPECIAL  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.

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

3. The  JSC’s  functions  will  include:

(a)  making  a  joint  assessment  of  the  equivalent  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  of  all  authorities  and  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

HARMONISATION  AND  INFORMATION  EXCHANGE

Article  18

Harmonisation

During  both  the  transitional  and  operational  phases  of  this  Agreement,  both  Parties  intend  to  continue  to
participate in the activities of the Global Harmonisation Task Force and utilise the results of those activities
to  the  extent  possible.  Such  participation  involves  developing  and  reviewing  documents  developed  by  the
Global  Harmonisation  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 one another, as permitted by law, of, and consult one another 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  1.

Article  20

Alert  system  and  exchange  of  post-market  vigilance  reports

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.

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Appendix  1

Relevant  legislation,  regulations  and  procedures

1.  For  the  European  Community  the  following  legislation  applies  to  Article  2(1):

(a)  Council  Directive  90/385/EEC  of  20  June  1990  on  the  approximation  of  the  laws  of  the  Member

States  relating  to  active  implantable  medical  devices.  Conformity  assessment  procedures.

—  Annex  II  (with  the  exception  of  section  4),

—  Annex  IV,

—  Annex  V;

(b) Council  Directive  93/42/EEC  of  14  June  1993  concerning  medical  devices.  Conformity  assessment

procedures.

—  Annex  II  (with  the  exception  of  section  4),

—  Annex  III,

—  Annex  IV,

—  Annex  V,

—  Annex  VI.

2.  For  the  United  States,  the  following  legislation  applies  to  Article  2(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) the 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
US.

4.  Unless  explicitly  included  by  joint  decision  of  the  Parties,  this  agreement  does  not  cover  any  US  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  1  June  1998,  unless  the  Parties  decide

otherwise.

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Class I products requiring premarket evaluations in the United States, included in scope of product coverage
at  beginning  of  transition  period

TABLE  1

Section
No

Regulation  Name
Product  Code  —  Device  Name

868.1910

868.5620

868.5640

868.5675

868.5700

868.6810

872.3400

872.3700

872.4200

ANESTHESIOLOGY  PANEL  (868)

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

CARDIOVASCULAR  PANEL

(None)

DENTAL  PANEL  (872)

Karaya  and  sodium  borate  with  or  without  acacia  denture  adhesive
KOM  —  Adhesive,  denture,  acacia  and  karaya  with  sodium  borate

Dental  mercury  (USP)
ELY  —  Mercury

Dental  handpieces  and  accessories
EBW  —  Controller,  foot,  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

874.1070

874.1500

EAR,  NOSE,  AND  THROAT  PANEL  (874)

Short  increment  sensitivity  index  (SISI)  adapter
ETR  —  Adapter,  short  increment  sensitivity  index  (SISI)

Gustometer
ETM  —  Gustometer

L  31/58

EN

Official  Journal  of  the  European  Communities

4.2.1999

Section
No

Regulation  Name
Product  Code  —  Device  Name

874.1800

874.1925

874.3300

874.4100

874.5300

874.5550

874.5840

876.5160

876.5210

876.5250

880.5270

880.5420

880.5680

880.6250

880.6375

880.6760

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

Anti-stammering device
KTH  —  Device, anti-stammering

GASTROENTEROLOGY  —  UROLOGY  PANEL  (876)

Urological  clamps  for  males
FHA  —  Clamp,  penile

Enema  kit
FCE  —  Kit,  enema,  (for  cleaning  purpose)

Urine  collector  and  accessories
FAQ  —  Bag,  urine  collection,  leg,  for  external  use

GENERAL  HOSPITAL  PANEL  (880)

Neonatal  eye  pad
FOK  —  Pad,  neonatal  eye

Pressure  infuser  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

Patient  lubricant
KMJ  —  Lubricant,  patient

Protective  restraint
BRT  —  Restraint,  patient,  conductive
FMQ  —  Restraint,  protective

4.2.1999

EN

Official  Journal  of  the  European  Communities

L  31/59

Section
No

Regulation  Name
Product  Code  —  Device  Name

882.1030

882.1420

882.4060

882.4545

882.4650

882.4750

886.1780

886.1940

886.4070

886.4300

886.5850

888.1500

888.4150

890.3850

890.5180

890.5710

NEUROLOGY  PANEL  (882)

Ataxiagraph
GWW  —  Ataxiagraph

Electroencephalogram  (EEG)  signal  spectrum  analyser
GWS  —  Analyser,  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

(None)

OPHTHALMOLOGY  PANEL  (886)

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

Keratone
HNO  —  Keratone,  ac-powered
HMY  —  Keratone,  battery-powered

Sunglasses  (non-prescription)
HQY  —  Sunglasses  (non-prescription  including  photosensitive)

ORTHOPEDIC  PANEL  (888)

Ac-powered  goniometer
KQX  —  Goniometer,  ac-powered

Callipers  for  clinical  use
KTZ  —  Calliper

PHYSICAL  MEDICINE  PANEL  (890)

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

L  31/60

EN

Official  Journal  of  the  European  Communities

4.2.1999

Section
No

Regulation  Name
Product  Code  —  Device  Name

892.1100

892.1110

892.1300

892.1320

892.1330

892.1410

892.1890

892.1910

892.1960

892.1970

892.5650

RADIOLOGY  PANEL  (892)

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  synchroniser
IVY  —  Synchroniser, electrocardiograph, nuclear

Radiographic-film illuminator
IXC  —  Illuminatore radiographic-film
JAG  —  Illuminatore  radiographic-film,  explosion-proof

Radiographic grid
IXJ  —  Grid, radiographic

Radiographic  intensifying  screen
WAM  —  Screen, intensifying, radiographic

Radiographic  ECG/respirator  synchroniser
IXO  —  Synchroniser,  ECG/respirator,  radiographic

Manual  radionuclide  applicator  system
IWG  —  System,  applicator,  radionuclide,  manual

878.4200

Introduction/drainage  catheter  and  accessories

GENERAL  AND  PLASTIC  SURGERY  PANEL  (878)

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

GBW  —  Catheter,  peritoneal

GBS  —  Catheter,  ventricular,  general  &  plastic  surgery

GCD  —  Connector,  catheter

GCC  —  Dilator, catheter
GCB  —  Needle,  catheter

4.2.1999

EN

Official  Journal  of  the  European  Communities

L  31/61

Section
No

Regulation  Name
Product  Code  —  Device  Name

878.4320

878.4460

878.4680

878.4760

878.4820

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

Removable  skin  staple
GDT  —  Staple,  removable  (skin)

Ac-powered,  battery-powered,  and  pneumatically  powered  surgical 
motor
GFG  —  Bit, surgical
GFA  —  Blade,  saw,  general  and  plastic  surgery
DWH  —  Blade, saw, surgical, cardiovascular
BRZ  —  Board,  arm  (with  cover)
GFE  —  Brush,  dermabrasion
GFF  —  Bur,  surgical,  general  and  plastic  surgery
KDG  —  Chisel  (osteotome)
GFD  —  Dermatome
GFC  —  Driver,  surgical,  pin
GFB  —  Head, surgical, hammer
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

instrument

878.4960

Air  or  ac-powered  operating  table  and  air  or  ac-powered  operating  chair  and
accessories
GBB  —  Chair,  surgical,  ac-powered
FQO  —  Tabel,  operating-room,  ac-powered
GDC  —  Tabel,  operating-room,  electrical
FWW  —  Tabel,  operating-room,  pneumatic
JEA  —  Tabel,  surgical  with  orthopedic  accessories,  ac-powered

880.5090

Liquid  bandage
KMF  —  Bandage, liquid

L  31/62

EN

Official  Journal  of  the  European  Communities

4.2.1999

Class  II  medical  devices  included  in  scope  of  product  coverage  at  beginning  of  transition  period

(US  to  develop  guidance  documents  identifying  US  requirements  and  EC  to  identify  standards  needed  to
meet  EC  requirements)

TABLE  2

RA

892.1000

Magnetic  resonance  diagnostic  device

MOS  —  Coil,  magnetic  resonance,  specialty

LNH  —  System,  nuclear  magnetic  resonance  imaging

LNI  —  System,  nuclear  magnetic  resonance  spectroscopic

DIAGNOSTIC  ULTRASOUND

RA

892.1540

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  mammographic  x-ray  systems)

RA

892.1600

Angiographic  x-ray  system

IZI  —  System, x-ray, angiographic

RA

892.1650

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

4.2.1999

EN

Official  Journal  of  the  European  Communities

L  31/63

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

882.1400

Electroencephalograph

GWQ  —  Electroencephalograph

HO

880.5725

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

HQC  —  Unit,  phacofragmentation

L  31/64

EN

Official  Journal  of  the  European  Communities

4.2.1999

SU

878.4580

Surgical lamp

HBI  —  Illuminator,  fiberoptic,  surgical  field

FTF  —  Illuminator,  non-remote

FTG  —  Illuminator,  remote

HJE  —  Lamp,  fluorescent,  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

FSQ  —  Light,  surgical,  instrument

NE

882.5890

Transcutaneous  electrical  nerve  stimulator  for  pain  relief

GZJ  —  Stimulator,  nerve,  transcutaneous,  for  pain  relief

NON-INVASIVE  BLOOD  PRESSURE  MEASUREMENT  DEVICES

CV

870.1120

Blood  pressure  cuff

DXQ  —  Cuff,  blood-pressure

CV

870.1130

Non-invasive  blood  pressure  measurement  system  (except  non-oscillometric)

DXN  —  System,  measurement,  blood-pressure,  non-invasive

HO

880.6880

Steam  steriliser  (greater  than  2  cubic  feet)

FLE  —  Steriliser, steam

CLINICAL  THERMOMETERS

HO

880.2910

Clinical  electronic  thermometer  (except  tympanic  or  pacifier)

FLL  —  Thermometer,  electronic,  clinical

AN

868.5630

Nebuliser

CAF  —  Nebuliser  (direct  patient  interface)

AN

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

4.2.1999

EN

Official  Journal  of  the  European  Communities

L  31/65

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

888.3030

Single/multiple  component  metallic  bone  fixation  appliances  and  accessories

KTT  —  Appliance,  fixation,  nail/blade/plate  combination,  multiple  component

OR

888.3040

Smooth  or  threaded  metallic  bone  fixation  fastener

HTY  —  Pin,  fixation,  smooth

JDW  —  Pin,  fixation,  threaded

SELECTED  DENTAL  MATERIALS

DE

872.3060

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

L  31/66

EN

Official  Journal  of  the  European  Communities

4.2.1999

Medical  devices  for  possible  inclusion  in  scope  of  product  coverage  during  operational  period

TABLE  3

Product  Family

Section
No

Device Name

Tier

ANAESTHESIOLOGY  PANEL

Anesthesia Devices

868.5160

Gas  machine  for  anesthesia  or  analgesia

868.5270

Breathing  system  heater

868.5440

Portable  oxygen  generator

868.5450

Respiratory  gas  humidifier

868.5630

Nebuliser

868.5710

Electrically  powered  oxygen  tent

868.5880

Anesthetic  vaporiser

Gas Analyzer

868.1040

Powered  Algesimeter

868.1075

Argon gas analyser

868.1400

Carbon  dioxide  gas  analyser

868.1430

Carbon  monoxide  gas  analyser

868.1500

Enflurane  gas  analyser

868.1620

Halothane  gas  analyser

868.1640

Helium gas analyser

868.1670

Neon  gas  analyser

868.1690

Nitrogen  gas  analyser

868.1700

Nitrous  oxide  gas  analyser

868.1720

Oxygen  gas  analyser

868.1730

Oxygen  uptake  computer

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

Predictive  pulmonary-function  value  calculator

868.1900

Diagnostic  pulmonary-function  interpretation
calculator

Peripheral Nerve
Stimulators

Respiratory
Monitoring

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

2

2

2

2

2

4.2.1999

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L  31/67

Product  Family

Section
No

Device Name

Tier

868.2025

Ultrasonic  air  embolism  monitor

868.2375

Breathing  frequency  monitor  (except  apnea  detectors)

868.2480

Cutaneous  carbon  dioxide  (PcCO2)  monitor

868.2500

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

868.2550

Pneumotachomometer

868.2600

Airway  pressure  monitor

868.5665

Powered  percussor

868.5690

Incentive  spirometer

Ventilator

868.5905

Nonconinuous  ventilator  (IPPB)

868.5925

Powered  emergency  ventilator

868.5935

External  negative  pressure  ventilator

868.5895

Continuous  ventilator

868.5955

Intermittent  mandatory  ventilation  attachment

868.6250

Portable  air  compressor

CARDIOVASCULAR  PANEL

Cardiovascular
Diagnostic

870.1425

Programmable  diagnostic  computer

870.1450

Densitometer

870.2310

Apex  cardiograph  (vibrocardiograph)

870.2320

Ballistocardiograph

870.2340

Electrocardiograph

870.2350

Electrocardiograph  lead  switching  adaptor

870.2360

Electrocardiograph electrode

870.2370

Electrocardiograph  surface  electrode  tester

870.2400

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

870.1100

Blood  pressure  alarm

870.1110

Blood  pressure  computer

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

1

2

2

1

1

2

2

2

2

2

L  31/68

EN

Official  Journal  of  the  European  Communities

4.2.1999

Product  Family

Section
No

Device Name

Tier

870.1120

Blood  pressure  cuff

870.1130

Non-invasive  blood  pressure  measurement  system

870.1140

Venous  blood  pressure  manometer

870.1220

Electrode  recording  catheter  or  electrode  recording
probe

870.1270

Intracavitary  phonocatheter  system

870.1875

Stethoscope  (electronic)

870.2050

Biopotential  amplifier  and  signal  conditioner

870.2060

Transducer  signal  amplifier  and  conditioner

870.2100

Cardiovascular  blood  flow-meter

870.2120

Extravascular  blood  flow  probe

870.2300

Cardiac monitor (including) cardiotachometer and rate
alarm)

870.2700

Oximeter

870.2710

Ear  oximeter

870.2750

Impedance  phlebograph

870.2770

Impedance  plethysmograph

870.2780

Hydraulic,  pneumatic,  or  photoelectric
plethysmographs

870.2850

Extravascular  blood  pressure  transducer

870.2870

Catheter  tip  pressure  transducer

870.2880

Ultrasonic  transducer

870.2890

Vessel  occlusion  transducer

870.2900

Patient  transducer  and  electrode  cable  (including
connector)

870.2910

Radiofrequency  physiological  signal  transmitter  and
receiver

870.2920

Telephone  electrocardiograph  transmitter  and  receiver

870.4205

Cardiopulmonary  bypass  bubble  detector

870.4220

Cardiopulmonary  bypass  heart-lung  machine  console

870.4240

Cardiovascular  bypass  heat  exchanger

870.4250

Cardiopulmonary  bypass  temperature  controller

870.4300

Cardiopulmonary  bypass  gas  control  unit

870.4310

Cardiopulmonary  bypass  coronary  pressure  gauge

870.4330

Cardiopulmonary  bypass  on-line  blood  gas  monitor

870.4340

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

2

2

2

2

2

2

4.2.1999

EN

Official  Journal  of  the  European  Communities

L  31/69

Product  Family

Section
No

Device Name

Tier

870.4370

Roller-type  cardiopulmonary  bypass  blood  pump

870.4380

Cardiopulmonary  bypass  pump  speed  control

870.4410

Cardiopulmonary  bypass  in-line  blood  gas  sensor

Cardiovascular
Therapeutic

870.5050

Patient  care  suction  apparatus

870.5900

Thermal  regulation  system

Defibrillator

870.5300

DC-defibrillator  (including  paddles)

870.5325

Defibrillator  tester

Echocardiograph

870.2330

Echocardiograph

Pacemaker  and
Accessories

870.1750

External  programmable  pacemaker  pulse  generator

870.3630

Pacemaker  generator  function  analyser

870.3640

Indirect  pacemaker  generator  function  anlayser

870.3720

Pacemaker  electrode  function  tester

Miscellaneous

870.1800

Withdrawal-infusion  pump

870.2800

Medical  magnetic  tape  recorder

None

Batteries,  rechargeable,  Class  II  devices

DENTAL  PANEL

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

Dental  electrosurgical  unit  and  accessories

872.6070

Ultraviolet  activator  for  polymerisation

872.6350

Ultraviolet  detector

Dental Material

872.3050

Amalgam alloy

872.3060

Gold-based alloys and precious metal alloys for clinical
use

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

2

2

2

L  31/70

EN

Official  Journal  of  the  European  Communities

4.2.1999

Product  Family

Section
No

Device Name

Tier

872.3200

Resin  tooth  bonding  agent

872.3250

Calcium  hydroxide  cavity  liner

872.3260

Cavity varnish

872.3275

Dental  cement  (other  than  zinc  oxide-eugenol)

872.3300

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

872.3750

Bracket  adhesive  resin  and  tooth  conditioner

872.3760

Denture  relining,  repairing,  or  rebasing  resin

872.3765

Pit  and  fissure  sealant  and  conditioner

872.3770

Temporary  crown  and  bridge  resin

872.3820

Root  canal  filling  resin  (other  than  chloroform  use)

872.3920

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  stabilising  splint

Orthodontic

872.5470

Orthodontic  plastic  bracket

EAR/NOSE/THROAT  PANEL

Diagnostic
Equipment

874.1050

Audiometer

874.1090

Auditory  impedance  tester

874.1120

Electronic  noise  generator  for  audiometric  testing

874.1325

Electroglottograph

874.1820

Surgical  nerve  stimulator/locator

Hearing Aids

874.3300

Hearing  aid  (for  bone-conduction)

874.3310

Hearing  aid  calibrator  and  analysis  system

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

2

2

2

4.2.1999

EN

Official  Journal  of  the  European  Communities

L  31/71

Product  Family

Section
No

Device Name

Tier

874.3320

Group  hearing  aid  or  group  auditory  trainer

874.3330

Master  hearing  aid

Surgical
Equipment

874.4250

Ear,  nose,  and  throat  electric  or  pneumatic  surgical
drill

874.4490

Argon  laser  for  otology,  rhinology,  and  laryngology

874.4500

ENT  microsurgical  carbon  dioxide  laser

GASTROENTEROLOGY/UROLOGY  PANEL

876.1500

Endoscope  and  accessories

876.4300

Endoscopic  electrosurgical  unit  and  accessories

Endoscope
(including
angioscopes,
laparscopes,
ophtalmic
endoscopes)

Gastroenterology

876.1725

Gastrointestinal  motility  monitoring  system

Hemodialysis

876.5600

Sorbent  regenerated  dialysate  delivery  system  for
hemodialysis

876.5630

Peritoneal  dialysis  system  and  accessories

876.5665

Water  purification  system  for  hemodialysis

876.5820

Hemodialysis  system  for  accessories

876.5830

Hemodialyser  with  disposable  insert  (kiil-type)

Lithotriptor

876.4500

Mechanical lithotriptor

Urology
Equipment

876.1620

Urodynamics  measurement  system

876.5320

Nonimplanted  electrical  continence  device

876.5880

Isolated  kidney  perfusion  and  transport  system  and
accessories

GENERAL  HOSPITAL  PANEL

Infusion  Pumps
and  Systems

880.2420

Electronic  monitor  for  gravity  flow  infusion  systems

880.2460

Electrically  powered  spinal  fluid  pressure  monitor

880.5430

Nonelectrically  powered  fluid  injector

880.5725

Infusion  pump

2

2

1

2

2

2

2

1

2

2

2

2

2

2

2

2

2

2

2

2

2

L  31/72

EN

Official  Journal  of  the  European  Communities

4.2.1999

Product  Family

Section
No

Device Name

Tier

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

880.5500

AC-powered  patient  lift

880.6880

Steam  Steriliser  (greater  than  2  cubic  feet)

NEUROLOGY  PANEL

882.1020

Rigidity analyser

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

Galvanic  skin  response  measurement  device

882.1550

Nerve  conduction  velocity  measurement  device

882.1560

Skin  potential  measurement  device

882.1570

Powered  direct-contact 
device

temperature  measurement

882.1620

Intracranial  pressure  monitoring  device

882.1835

Physiological signal amplifier

882.1845

Physiological signal conditioner

882.1855

Electroencephalogram  (EEG)  telemetry  system

882.5050

Biofeedback device

Echoencephalo-
graphy

882.1240

Echoencephalograph

RPG

882.4400

Radiofrequency  lesion  generator

2

2

2

1

1

2

2

2

1

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

4.2.1999

EN

Official  Journal  of  the  European  Communities

L  31/73

Product  Family

Section
No

Device Name

Tier

Neuro  Surgery

none

Electrode,  spinal  epidural

882.4305

Powered  compound  cranial  drills,  burrs,  trephines  and
their  accessories

882.4310

Powered  simple  cranial  drills,  burrs,  trephines  and
accessories

882.4360

Electric  cranial  drill  motor

882.4370

Pneumatic  cranial  drill  motor

882.4560

Sterotaxic  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

OBSTETRICS/GYNAECOLOGY  PANEL

Fetal  Monitoring

884.1660

Transcervical  endoscope  (amnioscope)  and  accessories

884.1690

Hysteroscope  and  accessories 
standards)

(for  performance

884.2225

Obstetric-gynecologic  ultrasonic  imager

884.2600

Fetal  cardiac  monitor

884.2640

Fetal  phonocardiographic  monitor  and  accessories

884.2660

Fetal  ultrasonic  monitor  and  accessories

884.2675

Fetal  scalp  circular  (spiral)  electrode  and  applicator

884.2700

Intrauterine  pressure  monitor  and  accessories

884.2720

External  uterine  contraction  monitor  and  accessories

884.2740

Perinatal  monitoring  system  and  accessories

884.2960

Obstetric  ultrasonic  transducer  and  accessories

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

1

2

2

2

2

L  31/74

EN

Official  Journal  of  the  European  Communities

4.2.1999

Product  Family

Section
No

Device Name

Tier

Gynecological
Surgery  Equipment

884.1720

Gynecologic  laparoscope  and  accessories

884.4160

Unipolar  endoscopic  coagulator-cutter  and  accessories

884.4550

Gynecologic surgical laser

884.4120

Gynecologic  electrocautery  and  accessories

884.5300

Condom

Ophthalm.
Implants

886.3320

Eye  sphere  implant

Contact  Lens

886.1385

Polymethylmethacrylate  (PMMA)  diagnostic  contact
lens

886.5916

Rigid  gas  permeable  contact  lens  (daily  wear  only)

Diagnostic
Equipment

886.1120

Ophthalmic 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

886.5725

Infusion  pump  (performance  standards)

886.3100

Ophthalmic  tantalum  clip

886.3300

Absorbable  implant  (scleral  buckling  method)

886.4100

Radiofrequency  electrosurgical  cautery  apparatus

(Diagnostic/
Surgery
Equipment)

Ophthalm.
Implants

Surgical
Equipment

2

2

2

2

2

2

2

2

1

1

1

1

1

1

1

1

2

1

1

2

1

2

2

2

2

2

2

2

2

4.2.1999

EN

Official  Journal  of  the  European  Communities

L  31/75

Product  Family

Section
No

Device Name

Tier

886.4115

Thermal  cautery  unit

886.4150

Vitreous  aspiration  and  cutting  instrument

886.4170

Cryophthalmic  unit

886.4250

Ophthalmic  electrolysis  unit  (AC-powered  device)

886.4335

Operating  headlamp  (AC-powered  device)

886.4390

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

ORTHOPEDIC  PANEL

Implants

888.3010

Bone  fixation  cerclage

888.3020

Intramedullary  fixation  rod

888.3030

Single/multiple  component  metallic  bone 
appliance  and  accessories

fixation

888.3040

Smooth  or  threaded  metallic  bone  fixation

888.3050

Spinal  interlaminal  fixation  orthosis

888.3060

Spinal  intervertebral  body  fixation  orthosis

Surgical
Equipment

888.1240

AC-powered  dynamometer

888.4580

Sonic  surgical  instrument  and  accessories/attachments

none

none

none

none

none

none

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

2

2

2

1

1

2

2

1

1

2

2

2

2

1

2

2

2

2

2

2

2

2

2

2

1

2

1

L  31/76

EN

Official  Journal  of  the  European  Communities

4.2.1999

Product  Family

Section
No

Device Name

Tier

PHYSICAL  MEDICINE  PANEL

Diagnostic
Equipement

890.1225

Chronaximeter

890.1375

Diagnostic electromyograph

890.1385

Diagnostic  electromyograph  needle  electrode

890.1450

Powered  reflex  hammer

890.1850

Diagnostic  muscle  stimulator

or  (Therapy)

890.5850

Powered  muscle  stimulator

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

RADIOLOGY  PANEL

MRI

892.1000

Magnetic  resonance  diagnostic  device

Ultrasound
Diagnostic

884.2660

Fetal  ultrasonic  monitor  and  accessories

892.1540

Nonfetal  ultrasonic  monitor

892.1560

Ultrasonic  pulsed  echo  imaging  system

892.1570

Diagnostic  ultrasonic  transducer

892.1550

Ultrasonic  pulsed  doppler  imaging  system

Angiographic

892.1600

Angiographic  x-ray  system

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

Image-intensified  fluoroscopic  x-ray  system

892.1670

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

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

1

2

1

4.2.1999

EN

Official  Journal  of  the  European  Communities

L  31/77

Product  Family

Section
No

Device Name

Tier

892.1860

Radiographic  film/cassette  changer

892.1870

Radiographic  film/cassette  changer  programmer

892.1900

Automatic  radiographic  film  processor

892.1980

Radiologic  table

CT  Scanner

892.1750

Computed  tomography  x-ray  system

Radiation Therapy

892.5050

Medical  charged-particle  radiation  therapy  system

892.5300

Medical  neutron  radiation  therapy  system

892.5700

Remote  controlled  radionuclide-applicator  system

892.5710

Radiation  therapy  beam-shaping  block

892.5730

Radionuclide  brachytherapy  source

892.5750

Radionuclide  radiation  therapy  system

892.5770

Powered  radiation  therapy  patient  support  assembly

892.5840

Radiation  therapy  stimulation  system

892.5930

Therapeutic  x-ray  tube  housing  assembly

Nuclear Medicine

892.1170

Bone  densitometer

892.1200

Emission  computed  tomography  system

892.1310

Nuclear  tomography  system

892.1390

Radionuclide  rebreathing  system

GENERAL/PLASTIC  SURGERY  PANEL

Surgical Lamps

878.4630

Ultraviolet  lamp  for  dermatologic  disorders

890.5500

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

1

2

2

1

2

2

2

2

2

2

2

2

2

1

2

2

1

2

2

2

2

2

2

2

L  31/78

EN

Official  Journal  of  the  European  Communities

4.2.1999

Appendix  3

Authorities  responsible  for  designating  conformity  assessment  bodies

EC  access  to  the  US  market

US  access  to  the  EC  market

—  Belgium

Food  and  Drug  Administration  (FDA)

la 

de 

publique, 
Ministe`re 
l’Environnement  et  de  l’Inte´gration sociale
Ministerie  van  Volksgezondheid,  Leefmilieu  en
Sociale Inetgratie

Sante´

de

—  Denmark

Sundhedsministeriet

—  Germany

Bundesministerium  für  Gesundheit

—  Greece

Υ(cid:240)(cid:239)υργ(cid:229)(cid:221)(cid:239)  Υγ(cid:229)(cid:221)Æς
Ministry  of  Health

—  Spain

Ministerio  de  Sanidad  y  Consumo

—  France

Ministe`re  de  l’emploi  et  de  la  solidarite´
Ministe`re  de  l’e´conomie,  des  finances  et  de
l’industrie

—  Ireland

Department  of  Health

—  Italy

Ministero  della  Sanitá

—  Luxembourg

Ministe`re  de  la  Sante´

—  Netherlands

Staat  der  Nederlanden

—  Austria

Bundesministerium  für  Arbeit,  Gesundheit  und
Soziales

—  Portugal

Ministerio  da  Saude

—  Finland

Sosiaali-ja terveysministeriö/Social-och
hälsovårdsministeriet

—  Sweden

Under  the  authority  of  the  Government  of
Sweden:
Styrelsen  för  ackreditering  och  teknisk  kontroll
(SWEDAC)

—  United  Kingdom

Department  of  Health

4.2.1999

EN

Official  Journal  of  the  European  Communities

L  31/79

Appendix  4

Conformity  assessment  bodies

EC  access  to  the  US  market

US  access  to  the  EC  market

Conformity  assessment  bodies  located  in  the  EC
shall  be  designated  by  the  Authorities  identified  in
Appendix  3.

Conformity  assessment  bodies  located  in  the  US
shall  be  designated  by  the  Authorities  identified  in
Appendix  3.

(to  be  provided  by  the  EC)

(to  be  provided  by  the  US)

L  31/80

EN

Official  Journal  of  the  European  Communities

4.2.1999

to  the  Agreement  on  Mutual  Recognition  between  the  European  Community  and  the  United
States  of  America

JOINT  DECLARATION

The Parties agree that, although in this exceptional case the Agreement on Mutual Recognition
between  the  United  States  of  America  and  the  European  Community  is  being  signed  while  the
consistency  of  the  various  linguistic  versions  of  the  Agreement  is  being  verified,  notification  of
the  completion  of  their  respective  procedures  for  the  entry  into  force  of  the  Agreement,  as
referred to in Article 21(1) of the Agreement, will be made only after the Parties have completed
the  verification  of  the  texts  signed  today  and,  through  agreement  between  the  Parties,  any
discrepancies  have  been  brought  into  conformity  with  the  English  text.

Done  at  London  on  the  eighteenth  day  of  May  in  the  year  one  thousand  nine  hundred  and
ninety-eight.

For  the  European  Community

For  the  United  States  of  America