With much fanfare, in January 2023, the European Commission released its proposal to extend the MDR transition periods and abolish the ‘sell-off’ deadline, after which medical devices and in vitro diagnostics (IVDs) would have to be withdrawn from the EU and EEA market. Today, the proposal has been adopted via Regulation 2023/607 (the Regulation), and will come into force today, 20 March 2023. This date is now important, as CE certificates that expired before today may be able to be considered as valid if certain conditions are met. Certificates that expire from today until the new transition periods will be considered as valid if the conditions set out below are met. This provides important breathing space for companies and should ensure that a large number of devices are not withdrawn from the market over the next year.
Stated to be due to the COVID-19 pandemic, in April 2020 the date of full application of the MDR was postponed by one year to 26 May 2021. At that time, the date of 26 May 2024 was maintained as the last date when ‘legacy’ medical devices could be placed on the market.
As set out in our blog, it has recently been recognised that due to the insufficient capacity of Notified Bodies to enable the conformity assessment of a large number of devices to be undertaken before 26 May 2024, as well as manufacturers not yet being able to demonstrate compliance with the requirements of the MDR, the availability of medical devices was likely to be seriously affected, causing significant disruption to supply chains and to healthcare.
Therefore, as a matter of urgency, it has been necessary to:
- extend the transition periods during which legacy devices that remain in conformity with the old regime can be placed on the market, and
- extend the validity of certificates issued under the previous medical device regime that have already expired, subject to certain conditions.
The new Regulation introduces these changes into the MDR, and extends the length of the transition period applicable to a device. The length of that extension depending on the risk class of the device concerned; the period is shorter for devices falling into a higher risk class, and longer for those devices falling into a lower risk class.
Notably, the Regulation entirely removes the ‘sell-off’ deadline (previously until 26 May 2025), by when devices already placed on the EU and EEA market could remain in the supply chain, and made available to end users, without having to be taken off the market. To prevent the unnecessary disposal of safe devices placed on the market within the new applicable transition periods, a device may now remain on the market and continue to be made available (sold) for an unlimited time.
Extension to transition periods
The Regulation provides that certificates issued by Notified Bodies from 25 May 2017 under the old regime, valid on 26 May 2021 and not withdrawn since, shall remain valid after the period indicated on the certificate until the following dates, and provided conditions are met:
- 31 December 2027: Class III and Class IIb implantable (with exceptions);
- 31 December 2028: Class IIb (with exceptions), Class IIa and Class I sterile or measuring;
- 31 December 2028: devices that did not require Notified Body involvement to obtain a CE certificate under the old regime, for which the declaration of conformity was drawn up prior to 26 May 2021, and do require Notified Body involvement under the MDR.
The conditions that have to be met for the above dates to apply are as follows:
- device continues to comply with the old regime;
- no significant change to design/intended purpose;
- do not present unacceptable risk to the health or safety of users;
- by 26 May 2024, manufacturer must have put a QMS in place in compliance with MDR;
- by 26 May 2024, manufacturer has made a formal application for conformity assessment of the device (or a device intended to substitute that device); and by 26 September 2024, the Notified Body and manufacturer have signed an agreement in accordance with MDR.
Certificates that expired before today 20 March 2023, shall be considered valid until the above dates, provided one the following conditions have been met:
- before the date of expiry of the certificate, the manufacturer and a Notified Body have signed a written agreement in accordance with the MDR for the conformity assessment in respect of the device covered by the expired certificate or in respect of a device intended to substitute that device;
- a competent authority of a Member State has granted a derogation from the applicable conformity assessment procedure in accordance with Article 59(1) MDR (allowing for a competent authority to authorise the placing on the market of a specific device in a Member State, where the conformity assessment procedures have not been met), or has required the manufacturer to carry out an assessment, in accordance with Article 97(1) (bringing a non-compliance, which does not present an unacceptable risk to health or safety of patients to an end within a specified period).
Where a transition period applies to a device under these provisions, requirements within the MDR in relation to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices will apply in place of the corresponding requirements under the old regime. Provisions relating to the transfer of surveillance responsibilities from one Notified Body to another, and the timeframes for this, have also been included.
What about the IVDR
The extensions to the transition period in the Regulation do not apply to IVDs under the IVDR, save that the ‘sell-off’ deadline under the IVDR has also been removed. In January 2022, a staggered extension of the IVDR transition period was adopted, ranging from 26 May 2025 for higher risk IVDs to 26 May 2027 for lower risk IVDs, and to 26 May 2028 for certain provisions concerning devices manufactured and used in health institutions. However, the limited capacity of Notified Bodies to undertake conformity assessments will inevitably affect IVDs in a similar way to standard devices (if not more so given how few IVDs were subject to conformity assessment with the involvement of a Notified Body under the old regime). Due to this, combined with the complexity of the new rules under the IVDR, we would expect that the current transition periods under the IVDR will also be extended to bring them into line with the new Regulation, though this subject has not yet been broached by the European Commission.
Position in the UK
The MDR and IVDR apply in Northern Ireland, but do not apply in Great Britain. Instead, the MHRA had stated that a device with a valid EU CE mark can be placed on the GB market until 30 June 2023. The MHRA is currently considering the implications of the revisions to the MDR and IVDR and will publish guidance (and law where necessary) shortly.