EU MDR and IVDR Implementation: Signs of Relaxing Transitioning Regime and Bridging Measures

Concerns over possible medical device shortages in the EU have led to two recent developments that will affect the implementation of the Medical Device Regulation[1] (MDR) and In Vitro Diagnostic Medical Device Regulation[2] (IVDR) :

1. The EU Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) discussed the outline of an EU Commission (Commission) proposal for targeted amendments of the transition periods under the MDR and IVDR on December 9, 2022, which will be incorporated into a draft legislation by the beginning of 2023.
2. In a new position paper of the Medical Device Coordination Group (MDCG) (MDCG 2022-18), which was announced at the EPSCO meeting and published shortly thereafter, the MDCG discusses the use of bridging measures to provide a temporary solution to certificates that are expiring through application of Article 97 MDR.

Background

Due to the grave shortage of notified body capacity and the sheer amount of medical devices and in-vitro medical devices (IVD), which need to be recertified under the new legislative framework, most manufacturers will not be able to attain MDR or IVDR certification before the end of the respective transition period, which for medical devices ends as early as May 2024.

The scope of the problem is immense: there have been 8,120 applications from manufacturers and 1,990 certificates granted under the MDR so far. By contrast, 22,793 valid certificates issued under the Medical Devices Directive[3] (MDD) and Active Implantable Medical Devices Directive[4] (AMDD) are due to expire on May 26, 2024, at the latest. If the current rate of certificate issuance continues without change, the number of MDR certificates issued by May 2024 may reach around 7,000. Furthermore, the number of notified bodies remains a bottleneck—36 bodies have been designated under the MDR, but a further 26 applications are currently being processed.

Commissions Suggestions

During the EPSCO meeting on December 9, 2022, health ministers from the EU member states joined forces to support the Commission’s proposal to extend the transitional provisions in Article 120 MDR, which were already outlined prior to the meeting in a Commission’s information note of December 6, 2022. The Commission precipitated this development in response to urgent concerns expressed by several EU member states, members of the European Parliament, stakeholders, the MDCG and feedback from notified bodies.

Among other things, the Commission suggests the following MDR amendments (despite the proposal claiming to extend both the MDR and IVDR, the suggested transition period extensions only cover the MDR):

To extend the transitional period in Article 120(3) MDR with staggered deadlines depending on the risk class of the device. Class III and class IIb devices (high risk) may extend to 2027 and class IIa and class I devices (medium risk) may extend to 2028 (low risk);

If needed for legal and practical reasons, to extend the validity of MDD/AMDD certificates;

Set conditions to be fulfilled in order to ensure that the extension applies only to devices that do not present any unacceptable risk to health and safety, have not undergone significant changes in design or intended purpose and for which the manufacturers have already undertaken the necessary steps to launch the certification process under the MDR, such as adaptation of their quality management system to the MDR and submission and/or acceptance of the manufacturer’s application for conformity assessment by a notified body before a certain deadline (e.g. May 26, 2024); and To remove the ‘sell off’ provision in Article 120(4) MDR.

The suggested extended transition periods for medical devices under the MDR would be staggered according to risk classes:

The EPSCO unanimously supported extending the transition periods and opted for a swift adoption. The Commission’s proposal will be presented at the beginning of next year, but it’s unknown what it will entail and to which specific dates the transitional periods will be extended. While it is unclear when the changes will become effective, previous corrigenda have demonstrated that adoption can be swift. It will be worth monitoring further developments and details in the coming months.

MDCG Position Paper on the Application of Article 97 MDR to Devices with Expired or Expiring Certificates

The Commission also saw a need for bridging measures before this legislative change can be implemented, which led to the MDCG position paper (MDCG 2022-18) that seeks to ensure the application of Article 97 MDR to legacy devices under the MDD or AMDD. This is in line with prior position papersMDCG 2022-11 andMDCG 2022-14, which had already indicated the use of Article 97 MDR measures.

The original purpose of Article 97 MDR was to allow EU member states to issue exemptions for medical devices that do not comply with the requirements of the MDR, but do not pose an unacceptable risk to patients or other individuals. In this case, the competent authorities (usually the national regulatory agency responsible for medical devices) can require the manufacturer or other relevant economic operators to correct the non-compliance within a reasonable amount of time.

The MDCG 2002-18 recommends, with a coordinated set of criteria, that EU member states may apply this mechanism to devices that are ‘in transition’ from the MDD or AMDD to the MDR or, respectively, for which, despite reasonable efforts undertaken by the manufacturer to obtain certification under the MDR, the relevant conformity assessment procedure involving a notified body has not been concluded in time.

The major advance of this position paper is that EU member states should recognize Article 97(1) MDR decisions issued by other EU member states, requiring only one application to cover the entire European Union.

Manufacturers whose certificates have expired or will expire before receiving their notified body certificate under the MDR are advised to proactively inform the competent authority of the EU member state in which they or their authorized representative have their registered place of business about the forthcoming or incurred non-compliance with the relevant MDR requirements. An evaluation of the risk posed by the device, as well as any other non-compliance requirements, is then required by the competent authority. As long as the competent authority determines that there is no unacceptable risk to health and safety, Article 97(1) MDR will apply.

Non-compliance must be resolved within a reasonable and clearly defined timeframe, and the manufacturer should already have undertaken reasonable efforts to transition its device to the MDR. That means, in particular, that the manufacturer’s application for conformity assessment under the MDR should have been accepted by a notified body and a written agreement signed by the notified body and manufacturer in line with section 4.3 of Annex VII MDR.

Conclusion

Both developments are to be welcomed, as they have the potential to take an enormous amount of pressure off the market. However, the Commission’s proposal is not final, and there remains a lack of clarity as to the details of the proposed extensions.

For example, according to the Commission’s proposal, an extension may only be granted for devices whose manufacturers have already taken steps to initiate certification procedures under the MDR, the uncertainty about what this means poses a problem. Yet it is unclear under which conditions this is the case. Does this require that the manufacturer must only adapt his quality management system, or would the notified body have to have accepted the manufacturer's application for conformity assessment?

Moreover, in terms of extensions of MDD certificates, it is unclear when, according to the Commission’s proposal, such an extension is needed for “legal and practical reasons” and whether such an extension would be granted retroactively to already expired certificates.

The most significant challenges with respect to the MDCG position paper seem to be that it is unclear how it relates to a proposed extension of the validity period for certificates under Article 120(2) beyond May 26, 2024, and that it remains to be seen how competent authorities will manage the influx of applications for Article 97 MDR exemptions. It is quite conceivable that the competent authorities for Article 97 MDR exemptions turn out to be a bottleneck, just as notified bodies do for MDR certification.

Watch this spot for further information on the latest developments in MDR and IVDR implementation.

MoFo Research Assistant Nicole Gebert contributed to this article.

[1] Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017

[2] Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017

[3] Council Directive 93/42/EEC of 14 June 1993

[4] Council Directive 90/385/EEC of 20 June 1990