Author
Alison Dennis

Alison Dennis

Partner

Read More
Author
Alison Dennis

Alison Dennis

Partner

Read More

10 January 2023

Medical Device Regulations – 1 of 3 Insights

The EU MDR extension explained – next steps for manufacturers

  • Briefing

Proposal – for now

Further to the proposal discussed in our previous articles (see Proposal for an extension of transition times for the EU MDR and Transitional periods, extensions and derogations – help for manufacturers waiting for their MDR certificates), the European Commission has published a legislative proposal for extending the transition period for legacy devices that are now regulated under the Medical Device Regulations 2017/745 (MDR). This is currently just a proposal and will need to go through the EU legislative process before becoming law. This process will need to be shortened to weeks or, at worst, a few months, given the urgent need for medical device companies to be able to take advantage of these extensions to keep their products on the market.

Devices benefitting 

The extension provisions apply to a device if:

  • It was certified by a notified body under the Medical Device Directive 93/42/EC (MDD) or the Directive on Active Implantable Medical Devices 90/385/EEC (AIMD).
  • The MDD or AIMD certificate was valid at the date of application of the MDR (26 May 2021), and not later withdrawn (even if the certificate expired prior to the date of this new extension legislation).
  • Either: i) before the certificate expired the manufacturer and a notified body have signed a written agreement with a notified body for the conformity assessment of the device or a device intended to substitute for the legacy device or ii) a competent authority has granted an Article 59(1) or 97(1) derogation in respect of the device.

Length of extension (excluding custom-made implantable devices)

Once in force, devices benefiting from the extension of their certificates may be placed on the market or put into service until:

  • 31 December 2027 - for class III devices and class IIb implantable devices sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors.

  • 31 December 2028 - for all other devices, which are class IIb devices not included in a) above, class IIa devices, and class I devices that are placed on the market in a sterile condition or which have a measuring function.

Conditions applicable (excluding custom-made implantable devices)

Devices that are to be placed on the market or into service with the benefit of this extension must continue to meet the following conditions during the extension period:

  • Compliance with MDD/AIMD, as applicable.

  • No significant changes in design or intended purpose.

  • Don't present an unacceptable risk to the health or safety or patients, users or other persons, or to other aspects of the protection of public health.

  • By 26 May 2024 the manufacturer must have: i) a QMS compliant with the MDR in place and ii) applied to a notified body for a conformity assessment.

Separate provision for custom-made implantable devices

Class III custom-made implantable devices benefit from an extension to 26 May 2026 if:

  • By 26 May 2024 the formal application has been made with a notified body for a conformity assessment.

  • By 26 September 2024 the notified body and manufacturer have signed a written agreement in respect of that conformity assessment.

How does this fit with derogations under Article 97 MDR?

If the proposal becomes law, legacy devices that fit the criteria for the MDD/AIMD certificate extension will not require an Article 97 derogation to be able to stay on the market for the extension period, except if the written agreement with the notified body for the conformity assessment was not signed before the MDD/AIMD certificate expired. In this situation the manufacturer will need to apply for and obtain an Article 97 derogation, or alternatively an Article 59(1) derogation, in order to get the benefit of this legislation, assuming that all the other criteria are met.

Continuous sales

Devices lawfully placed on the market under MDD or AIMD provisions, or under the extensions of the relevant certificates, might continue to be sold (made available) without limit in time.

What manufacturers should do

Manufacturers should make an application for a derogation under Article 97 if their MDD/AIMD certificates have already expired and if in advance of that expiration, they did not already have a written agreement for a conformity assessment under the MDR with a notified body.

Manufacturers with expired MDD/AIMD certificates or certificates likely to expire in less than six months might consider applying for an Article 97 derogation now, in case the proposal does not become EU law in a shortened timeframe.  

Manufacturers with certificates that expire at least six – eight months from now should keep a watching brief on the legislative process and if the proposal has not become law at least six months before the due date for expiry of their certificates, apply for an Article 97 derogation. 

See our article, Transitional periods, extensions and derogations – help for manufacturers waiting for their MDR certificates, for an explanation on how to apply for a derogation under Article 97 MDR.

If the criteria for an Article 97 MDR application are not met, there is the alternative of an Article 59(1) derogation application. These must be applied for to each individual competent authority which will grant a derogation solely in relation to their own country. However, if the purpose of the application is simply to be able to take advantage of the extension in the proposal, only one successful application is required. We can advise on the most amenable competent authorities.

The Article 59(1) derogations require that the application is made 'in the interest of public health or patient safety or health'. Most competent authorities are interpreting this narrowly by requiring that there are no alternatives available on the market, and the fact that without the device, patient health will be compromised. We have been successful in arguing that - where competing devices are available - their supply volume is not sufficient to meet demand. We have also successfully argued that – in a case where devices are intended to operate with an installed base - it is not financially viable to have hospitals change that installed base. Competent authorities are otherwise generally immune to arguments about pricing or the necessity of competition on the market.

Manufacturers should prioritise placing devices subject to these provisions on the market in the EU/EEA ahead of the end dates for the extensions. Despite those end dates, if the 'placing on the market' step is achieved in advance, then the devices can continue to circulate on the market thereafter, subject to the devices' shelf-lives.

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