COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT ON THE REVISION OF THE REGULATORY FRAMEWORK FOR MEDICAL DEVICES Accompanying the document Proposals for Regulations of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and on in vitro diagnostic medical devices
Date: 2012-09-26
Institutions: European Commission
Subjects: marketing standard, medical device, medical diagnosis, quality standard, safety standard, test tube fertilisation

EUROPEAN COMMISSION 

Brussels, 26.9.2012  
SWD(2012) 274 final 

COMMISSION STAFF WORKING DOCUMENT 

EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT ON THE REVISION OF 
THE REGULATORY FRAMEWORK FOR MEDICAL DEVICES 

Accompanying the document 

Proposals for Regulations of the European Parliament and of the Council 

on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 
and Regulation (EC) No 1223/2009  

and  

on in vitro diagnostic medical devices  

{COM(2012) 541 final} 
{COM(2012) 542 final} 
{SWD(2012) 273 final}

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COMMISSION STAFF WORKING DOCUMENT 

EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT ON THE REVISION OF 
THE REGULATORY FRAMEWORK FOR MEDICAL DEVICES 

Accompanying the document 

Proposals for Regulations of the European Parliament and of the Council 

on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 
and Regulation (EC) No 1223/2009  

and  

on in vitro diagnostic medical devices  

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INTRODUCTION 

1. 
The regulatory framework for medical devices consists of three main directives1 which cover 
a  huge  spectrum  of  products,  from  sticking  plasters  or  wheelchairs  to  X-ray  machines, 
scanners, pacemakers, drug-eluting stents or blood tests. All three directives,  adopted in the 
1990s,  are  based  on  the  "New  Approach"  and  aim  to  ensure  the  functioning  of  the  internal 
market  and  a  high  level  of  protection  of  human  health  and  safety.  Medical  devices2  are  not 
subject to a pre-market authorisation by a regulatory authority but to a conformity assessment 
which,  for  medium  and  high  risk  devices,  involves  an  independent  third  party,  a  so-called 
"Notified Body". Once certified, devices bear the CE marking which allows them to circulate 
freely in the EU/EFTA countries and Turkey. 

The impact assessment is divided in a main part (Part I) that focuses on the systemic issues 
which  are  relevant  for  the  entire  regulatory  framework,  and  two  separate  annexes  (Part  II) 
dealing  with  specific  issues  relevant  either  only  for  medical  devices  other  than  in  vitro 
diagnostic  medical  devices  or  only  for  in  vitro  diagnostic  medical  devices  (IVDs), 
respectively. Supporting documents are compiled as appendices (Part III).  

2. 

PROBLEM DESCRIPTION 

The existing regulatory framework has demonstrated its merits but it has been in place for 20 
years  and  like  any  regulatory  regime  dealing  with  innovative  products,  needs  revision. 
Moreover, it has recently come under harsh criticism in the media and the political arena, in 
particular  after  findings  of  the  French  health  authorities  that  a  French  manufacturer  (Poly 
Implant  Prothèse,  PIP)  over  several  years  apparently  used  industrial  silicone  instead  of 
medical  grade  silicone  for  the  manufacture  of  breast  implants  contrary  to  the  approval 
provided  by  the  notified  body,  causing  potential  harm  to  thousands  of  women  around  the 
world. Several weaknesses which undermine the main objectives of the three medical devices 
directives,  i.e.  the  safety  of  medical  devices  and  their  free  circulation  within  the  internal 
market, were identified in a public consultation held by the Commission in 2008, followed by 
another  public  consultation  targeted  at  IVD-related  aspect  held  in  2010.  In  the  light  of  the 
envisaged  revision  of  the  EU  regulatory  framework  for  medical  devices,  the  Commission's 
services  also  analysed  the  PIP  breast  implant  case  and  found  further  shortcomings  of  the 
existing regulations in addition to the already identified weaknesses. The findings, however, 
do not suggest that the EU system for regulating medical devices is fundamentally unsound. 
The  present  revision  aims  at  overcoming  the  flaws  and  gaps  while  maintaining  the  overall 
objectives of the legal framework. 

2.1. 

Systemic issues 

The main weaknesses of the current system exist in the following areas:  

Oversight of Notified Bodies  

Notified Bodies take responsibilities in areas of public interest and remain answerable to the 
competent  authorities  of  the  Member  States.  Currently  78  Notified  Bodies  are  designated 
under  the  three  medical  devices  directives.  Authorities,  manufacturers  and  Notified  Bodies 
themselves  report  significant  differences  as  regards,  on  the  one  hand,  the  designation  and 
monitoring  of  the  Notified  Bodies  and,  on  the  other  hand,  the  quality  and  depth  of  the 

1 

2 

Council  Directive  90/385/EEC  on  active  implantable  medical  devices  (AIMDD),  Council  Directive 
93/42/EEC on medical devices (MDD), and Directive 98/79/EC of the European Parliament and of the 
Council on in vitro diagnostic medical devices (IVDD). 
In this text, medical devices shall be understood as referring also to in vitro diagnostic medical devices. 

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conformity  assessment performed by  them, in  particular in relation to the assessment of the 
manufacturers'  clinical  evaluation  or  the  use  of  their  existing  powers,  such  as  unannounced 
factory inspections or product checks. This leads to an uneven level of protection of patients' 
and users' safety as well as to a distortion of the competition between manufacturers of similar 
products. 

Post-market safety 

A central pillar of the regulatory system is the right of Member States to restrict or ban the 
marketing of a device when it may compromise the health and safety of a patient, user or third 
person or when the CE marking has been illegally affixed to a product. But experience with 
the application  of  the  vigilance system and other legal instruments available to the Member 
States (e.g. safeguard clauses) has shown that national competent authorities do not have all 
the necessary information available and react in different ways to the same problems which 
puts into question a harmonised level of protection of patients and users in the EU and also 
creates obstacles to the internal market. 

Transparency and traceability  

No  exact  data  exist  as  regards  the  medical  devices  placed  on  the  European  market.  Several 
Member  States  have  set  up  their  own  electronic  registration  tools.  Multiple  registration 
requirements  in  individual  Member  States  place  a  considerable  administrative  burden  on 
manufacturers and authorised representatives when they want to market a product in different 
Member  States.  Some  European  countries  have  also  started 
traceability 
requirements  on  economic  operators  (manufacturers,  importers,  distributors,  hospitals)  since 
the  traceability  of  medical  devices  is  currently  not  regulated  at  EU  level.  The  national 
systems,  however,  are  not  compatible  with  each  other  and  do  not  allow  traceability  across 
borders which would be necessary for an EU-wide high level of patient safety.  

imposing 

Access to external expertise  

External  experts  (e.g.  healthcare  professionals,  academics)  are  currently  not  involved  in  the 
regulatory  process 
in  a  structured  way.  Regulators,  healthcare  professionals  and 
manufacturers  have  expressed  the  need  to  make the  advice  of  scientific  and  clinical  experts 
available in the decision-making process to keep pace with the innovation of products.  

Management of the regulatory system 

The  management  of  the  regulatory  system  at  EU  level  has  shown  weaknesses  which  have 
been  reported  by  various  interested  parties,  i.e.  healthcare  professionals,  patients,  insurers, 
manufacturers  and  the  media.  It  is  considered  as  not  sufficiently  efficient  and  effective. 
Indeed, there is no legal basis in the medical devices directives to ensure an overview of the 
situation at EU level and appropriate coordination between the Member States. There is a lack 
of  technical,  scientific  and  logistic  support  to  the  cooperation  between  Member  States,  of 
solid IT tools to manage the system, and of consolidated scientific and clinical expertise. This 
leads to a lack of uniform application of the rules and of common reactions in the European 
market  and  compromises  patient  and  user  safety  as  well  as  the  good  functioning  of  the 
internal market.  

Moreover,  the  demarcation  between  the  medical  device  directives  and  other  regulatory 
frameworks applicable to e.g. medicinal products, biocides, food or cosmetics is not always 
clear which leads to the application of different legal regimes in the various Member States to 
the  same  products  (so-called  "borderline"  cases).  Finally,  the  obligations  of  economic 
operators are currently not clearly spelt out or not covered at all by the directives. Both issues 
may put patient safety at risk and lead to a fragmentation of the internal market. 

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2.2. 

Specific issues  

Regulatory  gaps  or  uncertainties  exist  with  regard  to  certain  products.  For  example, 
products  manufactured  utilising  non-viable  human  tissues  or  cells,  implantable  or  other 
invasive products without a medical purpose, and the reprocessing of single-use devices are 
currently  not  regulated  by  the  EU  legislation  on  medical  devices.  In  the  field  of  IVDs,  "in 
house"  tests  are  currently  exempted  from  the  IVD  Directive  but  the  application  of  the 
exemption  diverges  amongst  the  Member  States.  Moreover,  regarding  genetic  tests,  the 
application  of  the  IVD  directive  is  not  sufficiently  clear  and  might  lead  to  diverging 
interpretation  in  the  EU.  This  leads  to  different  levels  of  protection  of  patients  and  public 
health and hinders the creation of an internal market for those products.  

An important issue is the classification of IVDs for which the current approach in the IVD 
Directive,  i.e.  a  list  of  high  risk  IVDs  in  an  annex  to  the  directive,  is  different  from  the 
classification  approach  taken  for  the  other  medical  devices  and  recent  developments  at 
international  level.  In  2008,  the  Global  Harmonization  Task  Force  for  medical  devices 
(GHTF) adopted a classification system for IVDs based on the risk linked to their use which 
is more robust to technological evolution than the current EU approach.  

Furthermore,  the  requirements  of  the  IVD  Directive,  which  has  not  been  amended  since  its 
adoption  in  1998,  need  to  be  adapted  to  technological,  scientific  or  regulatory 
developments,  for  example  with  regard  to  the  clinical  evidence  to  be  provided  by 
manufacturers, the requirements for point-of-care or near-patient testing or to align to relevant 
modifications introduced over time for the other medical devices. Also in the field of medical 
devices, some legal provisions, such as the essential requirements and the criteria for the risk 
classification  of  devices,  do  not  sufficiently  reflect  the  technological  and  scientific 
developments  as  for  example  in  the  case  of  ingested  devices  or  devices  incorporating 
nanomaterials. Uncertainties also exist with regard to the requirements concerning the clinical 
evaluation of devices.  

Finally,  EU  legislation  currently  does  not  make  provision  for  any  coordination  between 
Member  States  regarding  the  assessment  of  applications  for  clinical  investigations  on 
medical devices to be conducted in more than one Member State. Manufacturers/sponsors 
must  submit  their  documentation  to  each  Member  State  and  are  then  subject  to  multiple 
queries  for  additional  information  which  increases  the  administrative  burden  and  costs.  In 
addition, the assessments of the Member States concerned may lead to different outcomes as 
regards  technical  and  safety  aspects  related  to  the  same  investigational  device.  This  also 
means  that  patients  participating  in  the  same  multi-national  investigation  are  subject  to 
different safety levels. Moreover, this revision provides the opportunity to align the provisions 
regarding  clinical  investigations  on  medical  devices,  where  appropriate,  with  the  recently 
adopted Proposal for a Regulation on clinical trials on medicinal products for human use3.  

3. 

NEED FOR EU ACTION AND SUBSIDIARITY  

The  current  medical  devices  directives  are  based  on  the  Treaty  provisions  regarding  the 
establishment  and  functioning  of  the  internal  market  (now  Article  114  TFEU).  The  Lisbon 
Treaty has added a legal basis in the area of public health for the adoption of measures setting 
high  standards  of  quality  and  safety  of  medical  products  (Article  168(4)(c)  TFEU).  Both 
policies are a shared competence between the Union and the Member States.  

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COM(2012)369. 

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According  to  the  current  medical  devices  directives,  devices  that  bear  the  CE  marking,  in 
principle,  can  freely  circulate  in  the  EU.  The  proposed  revision  of  the  existing  directives, 
which will integrate the modification of the Lisbon Treaty regarding public health, can only 
be  achieved  at  Union  level.  This  is  necessary  to  improve  the  level  of  protection  of  public 
health for all European patients and users, as well as to prevent Member States from adopting 
varying  product  regulations  which  would  result  in  a  further  fragmentation  of  the  internal 
market.  Harmonised  rules  and  procedures  allow  manufacturers,  especially  SMEs  that 
represent  more  than  80%  of  the  sector  (90%  for  IVDs),  to  reduce  costs  related  to  national 
regulatory  differences,  while  ensuring  a  high  and  equal  level  of  safety  for  all  European 
patients and users. 

4. 

OBJECTIVES OF THE EU INITIATIVE  

This revision pursues three overall objectives:  

• 

• 

• 

Overall objective A: To ensure a high level of protection of human health and safety  

Overall objective B: To ensure the smooth functioning of the internal market  

Overall  objective  C:  To  provide  a  regulatory  framework  which  is  supportive  for 
innovation and the competitiveness of the European medical device industry  

In addition, several specific objectives related to the individual problems identified contribute 
to the achievement of the overall objectives:  

• 

• 

• 

• 

• 

• 

• 

Objective 1: Uniform control of Notified Bodies 

Objective  2:  Enhanced  legal  clarity  and  coordination  in  the  field  of  post-market 
safety 

Objective 3: Cross-sectoral solution of "borderline" cases 

Objective  4:  Enhanced  transparency  regarding  medical  devices  on  the  EU  market, 
including their traceability  

Objective 5: Enhanced involvement of external scientific and clinical expertise  

Objective 6: Clear obligations and responsibilities of economic operators, including 
in the fields of diagnostic services and internet sales  

Objective  7:  Governance  -  efficient  and  effective  management  of  the  regulatory 
system 

In respect to the specific issues relevant either for medical devices other than IVDs or only for 
IVDs,  some  additional  specific  objectives  are  pursued  to  address  the  problems  in  the 
respective sectors, such as  

• 

• 

• 

• 

Covering  of  legal  gaps  and  loopholes,  specific  to  the  fields  of  medical  devices  or 
IVDs 

Appropriate  legal  requirements  taking  into  account  technological,  scientific  and 
regulatory developments, specific to the fields of medical devices or IVDs 

Appropriate and robust classification and conformity assessment of IVDs  

Enhanced  legal  certainty  and  coordination  in  the  field  of  clinical  evaluation  and 
investigations, in particular those conducted in more than one Member State, in the 
field of medical devices.  

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5. 

POLICY OPTIONS  

Three main options are discussed in the impact assessment:  

• 

• 

• 

No EU action (baseline scenario);  

Fundamental change: marketing authorisation of medical devices;  

Evolution: reinforcement of the current regime keeping the same legal approach. 

The third option is situated between the two extreme scenarios and builds on the strengths of 
the "New Approach", on which the current regime is based, while remedying the weaknesses 
identified. In the framework of this option, i.e. the further evolution of the current regulatory 
regime,  several  policy  options  have  been  developed  to  respond  to  each  of  the  specific 
objectives and to address the individual problems identified.  

6. 

COMPARISON OF POLICY OPTIONS AND ASSESSMENT OF THEIR IMPACTS 

The  "no  EU  action"  had  to  be  discarded  from  the  outset  because  the  Commission  is 
committed  to  aligning,  where  appropriate,  existing  legislation  to  the  New  Legislative 
Framework for the Marketing of Products4. More importantly, no action would mean that the 
problems described above would continue to exist, or even increase, putting public health and 
the  protection  of  device  users  and  patients  at risk.  In  addition,  no  action  at  EU  level  would 
likely prompt Member States to take action at national level which would further undermine 
the internal market. The PIP breast implants scandal made it evident that "no EU action" is 
not a defendable policy choice.  

The  option  of  a  fundamental  change  with  the  introduction  of  a  marketing  authorisation  of 
medical devices was also discarded. The transfer of the responsibility for the assessment of 
the safety and performance of medical devices from Notified Bodies to regulatory authorities 
and  the  replacement  of  the  CE  marking  by  a  marketing  authorisation  was  widely  rejected 
during  the  public  consultations  and  the  subsequent  dialogue  with  competent  authorities, 
manufacturers and most other stakeholders.  

A  decentralised  marketing  authorisation  (done  by  Member  States)  would  have  a  significant 
negative  impact  on  the  internal  market  for  medical  devices  because  the  application  of  the 
mutual  recognition  of  national  authorisations  would  not  provide  automatic  access  to  the 
market of the other Member States which could refuse the admission of products on grounds 
of  health  protection.  It  would  therefore  run  counter  to  one  of  the  main  objectives  of  the 
current directives. A  central marketing authorisation  (at EU level)  would require  building a 
new EU public body with a sufficiently skilled staff to assess devices, similar to the US FDA. 
It  would  have  significant  impact  on  the  EU  budget,  on  manufacturers  in  terms  of  costs  and 
administrative burden and on innovation in terms of time to market.  

Despite  calls  in  the  aftermath  of  the  PIP  breast implant  scandal  to  shift  to  a  system  of  pre-
market authorisation, the case has not  provided any  evidence that a  marketing authorisation 
granted by a governmental authority would have prevented deliberate fraudulent practices of a 
manufacturer occurring once a product is approved for being placed on the market. In fact, the 
PIP  case  rather  evidences  the  need  for  a  reinforced  system  for  post-market  safety  which  is 
dealt  with  in  the  policy  options  relating  to  objective  2.  In  the  absence  of  evidence  which 

4 

Regulation  (EC)  No  765/2008  of  the  European  Parliament  and  of  the  Council  setting  out  the 
requirements on accreditation and market surveillance for the marketing of products, and Decision No 
768/2008/EC of the European Parliament and of the Council on a common framework for the marketing 
of products. 

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would  support  a  centralised  evaluation  by  a  regulatory  authority  in  order  to  achieve  the 
objectives  of  this  revision,  such  a  radical  shift  in  the  regulatory  system  would  be 
inappropriate. 

Hence, the option of an evolution of the current regime keeping the same legal approach 
has been chosen. This will allow to evolve the existing system which has served as a model 
for  international  convergence  of  the  legislation  on  medical  devices  and  to  make  it  fitter  for 
purpose. It is supported by competent authorities, manufacturers and many other stakeholders 
and  is  best  suited  to  achieve  the  overall  objectives  of  the  legislative  initiative.  This  policy 
choice  is  further  detailed  by  individual  policy  options,  some  of  them  are  alternatives  whilst 
others may be cumulative, to achieve also the specific objectives pursued by the revision and 
to remedy the problems identified. The table below indicates the preferred policy options for 
each specific objective pursued.  

However, the impact assessment leaves the choice of the preferred option open for a decision 
to be taken at political level with regard to the following two issues:  

• 

Objective 1 (uniform control of Notified Bodies):  

– 

– 

transfer  of  the  competence  for  the  designation  and  monitoring  of  Notified 
Bodies to an EU body, or  

designation  and  monitoring  of  Notified  Bodies  by  the  Member  States  after 
involvement  of  "joint  assessment  teams"  composed  of  assessors  of  other 
Member States and of an EU body.  

• 

Objective  7  (governance  -  efficient  and  effective  management  of  the  regulatory 
system):  

– 

– 

extension  of  the  responsibility  of  the  European  Medicines  Agency  (EMA)  to 
medical devices and creation of a Medical Device Expert Group at this agency, 
or  

management  of  the  medical  device  regulatory  system  by  the  European 
Commission (with involvement of its Joint Research Centre) and creation of a 
Medical Device Expert Group supported by this institution. 

Specific Objectives 

Preferred Policy Options  

Problem 1: Oversight of Notified Bodies 

Objective 1: Uniform control of Notified Bodies 

New minimum requirements for Notified Bodies,  

and 

either Designation and monitoring of Notified Bodies by 
an EU body 

or  Designation  and  monitoring  of  Notified  Bodies  by 
Member  States  with  involvement  of  "joint  assessment 
teams" 

and 

Notification  requirement  regarding new  applications  for 
conformity assessment and possibility for ex ante control 

Problem 2: Post-market safety (vigilance and market surveillance) 

Objective 2: Enhanced legal clarity and coordination  Clarification  of  key  terms  and  of  the  obligations  of  the 

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in the field of post-market safety 

parties involved in the field of vigilance 

and 

Central  reporting  of  incidents  and  coordinated  analysis 
of certain high risk incidents 

and 

Promotion  of  cooperation  of  market  surveillance 
authorities 

Problem 3: Regulatory status of products 

Objective  3:  Cross-sectoral  solution  of  "borderline" 
cases 

Creation  of  a  cross-sectoral  expertise  on  borderline 
issues  and  possibility  to  determine  the  regulatory  status 
of products at EU level in certain sectors 

Problem 4: Lack of transparency and harmonised traceability  

Objective  4:  Enhanced 
regarding 
medical  devices  on  the  EU  market,  including  their 
traceability  

transparency 

Central registration of economic operators and listing of 
medical devices placed on the EU market 

Requirement for the traceability of medical devices 

and 

Problem 5: Access to external expertise  

Objective  5:  Enhanced  involvement  of  external 
scientific and clinical expertise  

Designation  of  an  expert  panel  and  EU  reference 
laboratories 

Problem 6: Unclear and insufficient obligations and responsibilities of economic operators, including in the 
fields of diagnostic services and internet sales 

Objective 6: Clear obligations and responsibilities of 
the  fields  of 
in 
economic  operators, 
diagnostic services and internet sales  

including 

Alignment  with  Decision 
additional 
and 
requirements 
clarification  of  obligations  in  the  field  of  diagnostic 
services 

representatives 

authorised 

768/2008, 

for 

Addressing internet sales by soft-law action  

and 

Problem 7: Management of the regulatory system 

Objective  7:  Governance  -  efficient  and  effective 
management of the regulatory system 

either  Extension  of  the  responsibility  of  the  European 
Medicines  Agency  (EMA)  to  medical  devices  and 
creation  of  a  Medical  Device  Expert  Group  at  this 
agency 

or Management of the medical device regulatory system 
by the European Commission and creation of a Medical 
Device Expert Group supported by this institution 

The following two tables indicate the preferred policy options in the field of medical devices 
other  than  IVDs  and  in  the  field  of  IVDs,  respectively,  in  relation  to  the  additional  specific 
objectives pursued in the respective sectors: 

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Issues relevant for medical devices other than in vitro diagnostic medical devices 

Specific Objectives 

Preferred Policy Options  

Problem MD-1: Scope - regulatory gaps or uncertainties 

Objective  MD-1:  Covering  of 
loopholes 

legal  gaps  and 

Regulate  products  manufactured  utilising  non-viable 
human cells and tissues as medical devices 

and 

Regulation  of  certain  implantable  or  other  invasive 
devices without a medical purpose within the MDD 

and 

Harmonized regulation of the reprocessing of single-use 
medical devices 

Problem MD-2: Adaptation of legal requirements to technological, scientific and regulatory developments 

Objective  MD-2:  Appropriate  legal  requirements 
taking  into  account  technological,  scientific  and 
regulatory developments 

Review  of 
rules  and  essential 
requirements regarding specific devices or technologies  

the  classification 

Problem MD-3: Clinical evaluation and clinical investigations, in particular those carried out in more than 
one Member State  

legal  certainty  and 
Objective  MD-3:  Enhanced 
coordination  in  the  field  of  clinical  evaluation  and 
investigations,  in  particular  those  conducted  in  more 
than one Member State 

for  clinical 
Introduction  of 
investigations and further clarification of key provisions 
in the field of clinical evaluation and investigations 

term  "sponsor" 

the 

and 

Coordinated  assessment  of  multi-national  investigations 
by  the  Member  States  where  the  investigation  is 
performed 

Issues relevant for in vitro diagnostic medical devices (IVD) 

Specific Objectives 

Preferred Policy Options  

Problem IVD-1: Scope – regulatory gaps or uncertainties 

Objective  IVD-1:  Covering  of 
loopholes 

legal  gaps  and 

Clarify  the  scope  of  the  exemption  for  "in  house"  tests, 
require  a  mandatory  accreditation  for  "in  house"  test 
manufacturers and subject high risk (class D) "in house" 
tests to the requirements of the IVDD 

and 

Amendment of the legal definition of an IVD to include 
tests providing information "about the predisposition to a 
medical condition or a disease" 

and 

Regulation  of  companion  diagnostics  under  the  IVD 
regulations  and  interaction  with  the  medicinal  products 
sector 

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Problem IVD-2: Classification of IVD and their appropriate conformity assessment, including batch release 
verification 

Objective 
IVD-2:  Appropriate 
classification and conformity assessment of IVD  

and 

robust 

the  GHTF  classification 

Adoption  of 
rules  and 
adaptation  of  the  conformity  assessment  procedures  to 
the relevant GHTF guidance 

and 

Batch  release  verification  for  high  risk  IVD  by  the 
manufacturer  under  the  control  of  a  Notified  Body  and 
EU reference laboratory 

Problem IVD-3: Unclear legal requirements and need for their adaptation to technological progress 

IVD-3:  Clear 

Objective 
legal 
requirements for enhanced safety and performance of 
IVD 

and  updated 

Legislative  clarification  of  the  requirements  for  the 
clinical evidence for IVD 

and 

Clarification  of  the  legal  requirements  in  respect  to 
point-of-care or near-patient IVD medical devices 

Alignment to the MDD where appropriate 

and 

The preferred policy options have been selected as they are the most suitable to enhance the 
protection of public health and patient safety throughout the EU, to improve the functioning 
of the internal market and to provide a regulatory framework that is supportive of innovation 
and the competitiveness of the European medical device industry, especially SMEs.  

In  the  selection  of  the  options,  the  different  benefits  and  costs  have  also  been  taken  into 
account5.  Some  preferred  options,  such  as  a  central  registration  of  economic  operators  and 
medical  devices  or  requirements  for  the  traceability  of  medical  devices,  will  lead  to 
administrative costs for economic operators. But these costs are justified by the objectives of 
this revision and will by far be compensated by savings due to the reduction of administrative 
costs of the same nature which currently or in the future incur at national level. For example, 
costs  for  the  central  registration  of  around  €21.6mio  would  be  compensated  by  savings  of 
around  €81.6mio  to  €157.1mio  caused  by  multiple  regi
stration  requirements  in  the  various 
Member States. Economic operators will therefore obtain a net benefit from a combination of 
the preferred options whilst at the same time the levels of transparency and of protection of 
public health will significantly be enhanced.  

There will also be some savings of costs for the national administrations: in the future some 
tasks  will  be  transferred  at  EU  level,  such  as  the  registration  of  economic  operators  and 
medical devices; duplication of tasks between some Member States will be avoided due to for 
example  the  coordinated  analysis  of  certain  serious  incidents;  some  skills,  knowledge  and 
equipment will be shared, such as in the field of market surveillance.  

At  EU  level,  the  estimated  budgetary  needs  for  the  implementation  of  the  preferred  policy 
options  range  from  €8.9mio/year  to  €12.5mio/year  depending  on  the  choice  between  the 
options left for a political decision. The biggest part of the financing will be needed for human 
resources (between 35-50 Full Time Equivalents, depending on the choice of policy options) 
dedicated to the technical, scientific and corresponding operational tasks necessary to ensure a 

5 

An overview of the costs and benefits of the preferred polify options is given in Appendix 9 of Part III 
of the impact assessment. 

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sustainable and efficient management of the system at EU level. The second biggest share will 
be needed for the development and maintenance of an IT infrastructure necessary to achieve 
the  objectives  of  the  revision  (in  average  ca.  €2mio/y ear  in  2014-2017  and  €1.8  in  2018  et 
sqq.).  

7. 

CONCLUSIONS, MONITORING AND EVALUATION  

The preferred options will contribute to a robust regulatory framework that  

• 

• 

• 

is adapted to present and future technical and scientific progress, 

contains clearer rules, more easily to be followed by economic  operators and to be 
implemented by national authorities, and  

provides  the  necessary  instruments  for  a  sustainable,  efficient  and  credible 
management at EU level.  

The  positive  aspects  of  the  current  system  (supportive  to  innovation,  giving  rapid  access  to 
market, cost efficient) will be maintained,  while the  negative aspects (unequal protection of 
public  health,  inconsistent  implementation  of  legal  requirements,  lack  of  trust  and 
transparency)  will  be  remedied.  This  will  enhance  the  safety  for  all  European  patients  and 
users  and  reinforce  Europe's  position  in  the  forefront  of  innovation  in  the  field  of  medical 
technology. It will boost the confidence in the CE marking for medical devices both in Europe 
and  in  the  world  and  will  thus  lead  to  a  smoother  functioning  of  the  internal  market  and 
international  trade.  The  revision  of  the  regulatory  framework  for  medical  devices  therefore 
contributes to the Single Market Act and to the Innovation Union, both part of the EUROPE 
2020 strategy.  

The  legislative  initiative  will  also  contribute  to  the  Commission's  simplification  programme 
by  transforming  the  existing  three  main  directives,  their  three  amending  directives  and  two 
Commission implementing directives into two regulations of the European Parliament and of 
the Council, by maintaining the co-regulation approach supported by standardisation and by a 
single registration instead of multiple national requirements.  

The  successful  implementation  of  the  future  regulatory  framework  for  medical  devices  will 
depend  on  several  factors.  Some  of  the  monitoring  or  evaluation tools set  out  in  the  impact 
assessment are the following:  

• 

• 

• 

• 

• 

Assistance  to  Member  States  regarding  alignment  of  the  national  legislation  to  the 
future EU regulatory framework and monitoring of this process.  

Roadmap  set  up  by  Commission  and  Member  States  for  the  assessment  and 
designation  of  all  existing  Notified  Bodies  according  to  the  new  requirements  and 
designation  process,  at  the  latest  three  years  after  entry  into  force  of  the  new 
legislation.  

Annual statistics regarding the number of incidents reported to the central vigilance 
database and the number of coordinated analysis regarding corrective actions. 

Timely  deployment  of  the  IT  infrastructure  in  close  co-operation  between  the 
operational services and the IT specialists. 

Full  implementation  of  a  European  Unique  Device  Identification  (UDI)  system  ca. 
10  years  after  entry  into  force  of  the  new  legislation  in  close  co-operation  with 
international partners, in particular with the US FDA, to ensure global compatibility 
and allow traceability between the respective jurisdictions. 

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• 

Report of the Commission to the European Parliament and to the Council about the 
achievements of the 'medical device package', ten years after its adoption, addressing 
the  impact  of  the  new  rules  with  respect  to  public  health/patient  safety,  internal 
market,  innovativeness  and  competitiveness  of  the  medical  device  industry  (with 
special attention to SMEs).  

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