New transitional periods for legacy devices under the EU Medical Devices Regulation

Now that the Regulation (EU) 2017/745 on medical devices (MDR) has been in effect for almost two years, major problems have transpired in the recent past for manufacturers and other economic operators who have not adapted their medical devices portfolio to the provisions yet. The previously applicable transitional period for “legacy devices” which can still be placed on the market and put into service in accordance with the requirements under the rules previously in place (Directive 90/385/EEC relating to active implantable medical devices and Directive 93/42/EEC concerning medical devices) were intended to expire in May 2024. However, the notified bodies are struggling to process the applications for re-certification in time, meaning that there is a risk of acute shortages of supplies.

As a remedial measure, Regulation (EU) 2023/607, which amends the MDR with regard to the transitional periods applicable to legacy devices and other aspects, took effect on 20 March 2023. This article provides an overview of the new regime, which is far from simple.

I. Background and lawmakers’ intention

The consolidated MDR version which has applied since 24 April 2020 provided for a transitional period for legacy devices until 26 May 2024. Until that date, it was to be possible to lawfully place on the market and put into service certain medical devices that still comply with the former Directives. This applied, for one, to medical devices that were classified as class 1 products under the former Directives but are in a higher risk class under the MDR, and thus require the involvement of a notified body in the conformity assessment procedure. It also applied to medical devices of classes IIa and higher for which notified bodies issued certificates during certain periods prior to 26 May 2021.

This transitional period was intended to absorb capacity shortages at notified bodies since the switch to the MDR involves a compulsory re-assessment of all medical devices for the medical device to remain marketable. In addition, notified bodies had to be newly designated and notified under the MDR to be able to perform their responsibilities. Despite the increase in the number of notified bodies over time, it became evident that the total capacity would be insufficient to complete re-certification of the large number of medical devices before 26 May 2024.

To avoid acute supply shortages that could result from this, EU lawmakers have presented Regulation (EU) 2023/607, which has now entered into force and amends the MDR. The Regulation is intended to provide relief in this tense situation.

II. New transitional periods: the most important changes

It should be noted, to begin with, that not all legacy devices can benefit from extended transitional periods as a result of the MDR amendment.

Instead, the following now applies:

1. Medical devices in classes I (sterile condition), I (measuring function) and IIa or higher with expiring certificates

Certificates issued by notified bodies after 25 May 2017 (original effective date of the MDR) in accordance with the previous rules that were still valid on 26 May 2021 (date of application of the MDR) and that have not been withdrawn afterwards will remain valid after the end of the period indicated on the certificate until

• 31 December 2027 for all class III devices, and for class IIb implantable devices except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors; or
• 31 December 2028 for class IIb devices other than those mentioned above, for class IIa devices, and for class I devices placed on the market in sterile condition or having a measuring function.

If the above certificates expired prior to 20 March 2023, the certificates can now remain valid until the dates stated above (31 December 2027 or 31 December 2028) if the following conditions are met:

• before the date of expiry of the certificate, the manufacturer and a notified body have signed a written agreement in accordance with Section 4.3, second subparagraph, of Annex VI to 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; or
• a competent authority of a Member State has granted a derogation from the applicable conformity assessment procedure in accordance with Article 59(1) of the MDR or has required the manufacturer, in accordance with Article 97(1) of the MDR, to carry out the applicable conformity assessment procedure.

2. Higher class medical devices under the MDR originally falling under class I

Medical devices which according to the old provisions fell in class I and are in a higher class under the MDR may now be placed on the market and put into service on 31 December 2028.

3. Joint requirements regarding extended transitional periods

For both product categories described above, the following additional conditions have to be met:

• The devices continue to comply with the old provisions (Directive 90/385/EEC or Directive 93/42/EEC, as applicable);
• there are no significant changes in the design and intended purpose;
• the devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health;
• the manufacturer has put in place a quality management system in accordance with Article 10(9) no later than 26 May 2024; and
• the manufacturer or the authorised representative has lodged a formal application with a notified body in accordance with Section 4.3, first subparagraph of Annex VII for conformity assessment in respect of the device or in respect of a device intended to substitute that device no later than 26 May 2024, and the notified body and the manufacturer have signed a written agreement in accordance with Section 4.3, second subparagraph, of Annex VII to the MDR no later than 26 September 2024.

In addition, MDR requirements relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices continue to apply for legacy devices in place of the corresponding requirements under the old provisions.

4. Class III custom-made implantable devices

Class III custom-made implantable devices may be placed on the market or put into service until 26 May 2026 without a certificate issued by a notified body in accordance with the conformity assessment procedure referred to in Article 52(8), second subparagraph, provided that

• the manufacturer or the authorised representative has lodged a formal application with a notified body in accordance with Section 4.3, first subparagraph, of Annex VII to the MDR for conformity assessment no later than 26 May 2024, and
• the notified body and the manufacturer have signed a written agreement in accordance with Section 4.3, second subparagraph, of Annex VII to the MDR no later than 26 September 2024.

5. Periods for selling current stocks no longer apply

Another important change is that the periods for selling current stocks will no longer apply. The new MDR will not include the previously applicable periods expiring on 26 May 2025 for legacy devices already placed on the market anymore. Legacy devices already placed on the market can therefore be sold for an indefinite period now, provided they are still safe and satisfy the applicable requirements.

III. Conclusion

The amendment certainly provides short-term relief in the process of adapting to the MDR, which has become an acute situation for many companies by now. However, on a closer look it just means a short breathing space for both the economic operators concerned and the notified bodies since it does not provide a remedy for the bottleneck caused by limited capacities at the notified bodies.

EU lawmakers are therefore already planning additional measures such as special solutions for certain product categories, as various sources indicate. As a result, some flexibility is urgently required to avoid supply shortages in the EU, or to prevent them from getting even worse, and to ensure that the EU remains attractive for manufacturers of medical devices.

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By the way: The MDR also falls within the scope of Directive (EU) 2020/1828 on representative actions. It provides for representative actions against infringements by traders against EU law and provisions transposing it into national law that harm or may harm the collective interests of consumers. For more information on representative actions in Germany and the recently published draft bill presented by the German Federal Ministry of Justice (BMJ), please see our news alert at: https://www.noerr.com/de/insights/neue-sammelklage-in-deutschland---update.