A proposal has been put forward to amend the transitional provisions for certain medical devices and in vitro diagnostic medical devices (amending Regulations (EU) 2017/745 (MDR)1 and (EU) 2017/746 (IVDR)2.
Amendments to these regulations have been prompted by factors which include the insufficient operating capacity of conforming assessment bodies as well as the unpreparedness of many manufacturers to meet the strengthened requirements of the MDR by the end of the transition periods. Taken together, there is the risk of shortages of medical devices on the EU market.
The MDR has been applicable since 26 May 20213. The transition period provided for will end on 26 May 2024 (based on Article 120(3)). The current provision extends the transition period;
– until 31 December 2027 for higher risk devices (class III and class IIb implantable devices except certain devices for which the MDR provides exemptions, given that these devices are considered to be based on well-established technologies) and
– until 31 December 2028 for medium and lower risk devices (other class IIb devices and class IIa, class Im, Is and Ir devices).
The overall goal of the proposed amendments is to maintain patients’ access to a wide range of medical devices while ensuring the transition to the new framework.
Take home messages of the proposed EU action:
– The proposal does not alter the MDR or IVDR in substance, it primarily facilitates additional time to transition to the MDR’s requirements to avoid shortages.
– It is intended that only devices that are safe and for which the manufacturers have taken steps to transition towards compliance with Regulation (EU) 2017/745 will benefit from the additional time.
– This provision extends the validity of certificates issued under Council Directives 90/385/EEC or 93/42/EEC that were valid on the day of the MDR’s date of application (26 May 2021) and which have not been withdrawn by a notified body.
– The extension is directly applicable, therefore changing the date on the individual certificates is not necessary. The length of the extension of the certificate’s validity corresponds to the length of the extended transition period laid down in the proposed Article 120(3a) to (3c) of the MDR.
– Regarding certificates that have already expired when the proposed amendment comes into force, the extension would be subject to the condition that, at the moment of the expiry, the manufacturer has signed a contract with a notified body for the conformity assessment of the device in question. Alternatively, if no such contract has been signed at the moment when the certificate expired, a national competent authority may have granted a derogation from the applicable conformity assessment procedure in accordance with Article 59 of the MDR or have required the manufacturer to carry out the conformity assessment procedure within a specific time period in accordance with Article 97 of the MDR.
– This provision deletes the current ‘sell-off’ date (27 May 2025) in Article 120(4) MDR. Consequently, devices placed on the market before the end of the transition period can be made further available on the market without a legal time restriction.
– The amendment of the IVDR is limited to the deletion of the ‘sell-off’ deadline in order to be consistent with the proposed change in the MDR.
Happy to discuss in more detail with you personally,
Dr. Sandra Ragaz, Partner, Leader Pharma & Life Science – International Indirect Tax & Regulatory
Tafadzwa Mlambo, Associate, VAT
Dominik Hofstetter, Associate, Pharma Regulatory
1 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).
2 Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).
3 Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions (OJ L 130, 24.4.2020, p. 18) had postponed the date of application of Regulation (EU) 2017/745 from 26 May 2020 to 26 May 2021 due to the COVID-19 outbreak and the associated public health crisis.