   
  
G/TBT/W/728  
 
10 March  2020 
(20-1850) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
EUROPEAN UNION - MEDICAL DEVICE REGULATI ON (MDR) AND  
IN VITRO DIAGNOSTIC MEDICAL DEVICES REGU LATION (IVDR)  
STATEMENT BY THE EUROPEAN UNION TO THE COMMITTEE ON TECHNICAL BARRIERS T O TRADE  
26 – 27 FEBRUARY  2020 
The following communication, dated 9 March  2020, is being circulated at the request of the 
delegation of the European Union . 
 
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1.  The European Union thanks the Delegations of the United States, Japan and the Republic of Korea 
for their commen ts on the Medical Devices Regulation (MDR) and In -Vitro Diagnostic Medical Devices 
Regulation (IVDR).  
2.  The new legislation on Medical Devices was adopted by the Council and the European Parliament 
in April 2017. This new framework sets high standards of quality and safety for medical devices and 
aims at ensuring the smooth functioning of the internal market. The new provisions  apply  from 
26 May 2020 for medical devices and 26 May 2022 for in vitro  diagnostic medical devices.  
3.  The transition period for the application of the new legislation is the result of a compromise in 
the interest of patient safety, and in response to scand als with defective medical devices in several 
Member States. It aims to ensure that the strengthened requirements of the new framework apply 
as soon as possible. Ensuring patient access to safe and efficient medical technologies is a priority 
for the Commi ssion and at the forefront of the implementation effort.  
4.  The Commission has ensured that the most critical mechanisms will be in place for rendering the 
legislation operational by 26 of May 2020. This includes the adoption of the most crucial 
implementing  acts and some 35 guidance documents and the establishment of the UDI 
(Unique  Device Identification) system. The expert panels will be operational at the application date 
as well as the registration module of the Eudamed database. The other parts of the Eu damed 
database will be made gradually available. The legislation provides in the meantime for alternatives 
to the Eudamed use.  
5.  Up to now, more than a dozen designations of Notified Bodies under the new Regulations have 
been made (together covering a major ity of the market) and additional designations are pending. 
In addition, most Notified Bodies have increased their resources, some by up to 50%.  An additional 
31 Notified Bodies have applied. It can be reasonably estimated that the number of designated 
Notified Bodies will significantly increase in 2020.  
6.  In order to help economic operators, the EU legislators have provided for a  grace mechanis m to 
smoothen the transition. The new Medical Devices Regulation thus continue to recognize under 
certain condition s the certificates issued in accordance with the current EU 's Medical Device Directive 
through the Medical Devices Regulation 's transition period (i.e. until May 2024) provided the 
certificate  has not reached its expiry date. Most Notified Bodies designate d for the existing legislation 
are therefore currently focusing their resources on re -issuing certificates with an expiry date in the 
nearer future. Some manufacturers have however requested a re -certification after the deadline 
given by the Notified Body or are not able to fulfil more specific requirements that have been 
introduced since the previous certification Overall, the grace period should however provide for 
ample time to receive a certification under the new Regulations.  G/TBT/W/728  
 
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  7.  It should be noted that th e scope of the transitional period was clarified by the corrigendum  
exercise finalised in December 2019, allowing also up -classified lower risk devices that would require 
the involvement of a Notified Body for the first time under the Medical Devices Regulation, to benefit 
from the transitional period. The corrigendum is estimated to have significantly alleviated pressure 
on Notified Bodies and to have ensured availability of certain essential devices (e.g. certain surgical 
instrument).  
8.  As a final resort (in duly justified cases and in the interest of public health or pati ent health or 
safety), national competent  authorities may authorise within their territory the placing on the market 
of specific devices which have not fulfilled the conformity assessment requirements. In exceptional 
cases, the Commission may decide to ext end those national measures to the territory of the Union 
for a limited duration.  
9.  Stakeholder organisations have reported that careful planning and preparations have enabled a 
vast majority of their members to take the measures needed for compliance with t he Medical Devices 
Regulation as from the application  date. Notified body associations have informed that they are 
dealing with the re -certifications requested within the deadlines given.  
10.  The option of postponing the date of application has been discussed  on several occasions during 
the last years in Council and Parliament, and each time the benefits of keeping the current deadlines 
have been found to outweigh the possible problems relating to bottlenecks of certification capacity, 
for which mechanisms to mitigate have been foreseen in the legislation.  
11.  At the meeting of EU Health Ministers on 9 December 2019, 22 Ministers took the floor. There 
was no request for postponing the application date. As requested by Ministers, the Commission is 
currently working closely with Member States to identify any remai ning essential deliverables crucial 
for finally rendering the legislation operational by 26 May 2020. These will be highlighted in a Joint 
implementation plan to be discussed with Member States early March 2020.  
12.  In light of all these elements and taking i nto account that the implementation activities are 
overall progressing according to plan, there are no grounds to explore any amendment to the 
transitional periods of the two Regulations. The EU is fully committed at this stage to ensure that 
the new syste m is introduced with no delay, to ensure a higher level of patient protection.  
 
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