As part of our series of blog posts covering the implementation of the EU Medical Devices Regulation (MDR), we comment below on the latest developments, including the deferred application of the MDR and the most recent guidance issued by the European Commission’s medical device coordination group (MDCG).
Deferral of the MDR
This is the month when it was all due to happen: after years of planning and preparing, the MDR was finally due to take effect on 26 May 2020. Industry has long argued that this timeline for implementation was unrealistic and undesirable (for various reasons, some of which we have previously discussed). However, the Commission showed little sign of any willingness to defer, and it was only in the context of the global coronavirus pandemic that its attitude shifted. On 23 April 2020, European Parliament and Council approved the Commission’s proposal to defer the application date of the MDR. The resulting Regulation (EU) 2020/561 refers to the “unprecedented magnitude of the current challenges” related to COVID-19 and to “the complexity” of the MDR as reasons for why it considers it “very likely that Member States, health institutions, economic operators and other relevant parties will not be in a position to ensure the proper implementation and application of [the MDR] from 26 May 2020”. The new Regulation therefore defers the application of the MDR by one year to 26 May 2021, and makes corresponding adjustments to the transitional periods contained in the MDR that would otherwise have been linked to 26 May 2020. The implementation of the IVDR is not affected by the new Regulation, and continues to apply from 26 May 2022.
As the Commission and Member State authorities are now focused on dedicating their time and resources to the health crisis, the implementation process of the MDR and IVDR has (understandably) been disrupted. The Commission’s ‘rolling plan’ – which contains a list of the essential implementing acts and actions that need to be introduced, as well as providing information on expected timelines and the current state-of-play – was last updated in December 2019 and does not, therefore, reflect the deferral of the MDR application date. In view of the uncertainties created by COVID-19, it is not possible to foresee what the revised implementation timeline will look like and when we can expect publication of key outstanding guidance. Until more information is available, it would nevertheless be sensible for companies to continue to press ahead with preparations for MDR/IVDR implementation based on the currently available legislation and guidance, to the extent this is possible under current market conditions.
As we’ve previously reported, the Commission recommended in March 2020 that the national derogation provisions contained in Article 59 of the MDR should be used to loosen the conformity assessment and market surveillance procedures, in order to support the response to the COVID-19 pandemic. Article 59 has now been amended by Regulation (EU) 2020/561, in line with this recommendation. The Commission will have the power to adopt Union-wide derogations, notwithstanding the delayed application of the MDR. The scope of Article 59 has been extended to national derogations made under the current MDD (and not just to those which will be made under the MDR), which in effect makes derogations under Article 59 MDR immediately available.
The MDR’s delayed implementation must also be considered in the perennial Brexit context. The UK’s transitional period (during which time EU laws remain applicable in the UK) is currently set to end before the MDR enters into application. This puts into question whether or not the UK will remain aligned with EU requirements, and implement the MDR and IVDR as previously anticipated. The MHRA has so far stated only that it is “taking steps to plan for after the end of the transition period [and] will provide guidance on this in due course in light of Government decisions required on the future of UK regulation”.
As part of the implementation process of the MDR, the MDCG is publishing guidance notes on various topics. The guidance notes are not legally binding, but their application is generally expected (much like the MEDDEV guidance under the current system). Our previous blog post discussed the MDCG guidance documents that were published in March. In April there was a further flurry of new and updated MDCG guidance documents, which we have summarised below:
- Clinical evaluation: Article 54(2) of the MDR lays down three criteria that exempt devices from the pre-market clinical evaluation consultation procedure with the involvement of expert panels. The MDCG had published a guidance note in 2019 setting out its interpretation of Article 54(2), and this updated guidance document includes details on the procedural operation of Article 54(2).
- Notified Body audits: This guidance document sets out alternatives to on-site audits of notified bodies in the context of COVID-19-related quarantine orders and travel restrictions. Although the guidance is stated to apply only to the MDD/AIMD, “in the event that the availability of devices is affected by COVID-19 restrictions the principles in [the] guidance may apply” also for MDR/IVDR.
- Equivalence: This document provides detailed guidance on the MDR’s provision for using clinical data related to an equivalent device in the clinical evaluation required for a device under conformity assessment. The guidance confirms that existing MEDDEV guidance on clinical evaluation will continue to apply also during the process of demonstrating clinical equivalence under the MDR, but it will be supplemented by this new guidance. An equivalence table is included to help manufacturers demonstrate equivalence and to identify the supporting data on a device by device basis. Products without an intended medical purpose listed in Annex XVI of the MDR are also addressed in the new guidance.
- Legacy devices: This new guidance document details what is meant by “sufficient clinical evidence” in the context of demonstrating conformity with the MDR’s General Safety and Performance Requirements for devices previously certified under the MDD/AIMD.
- Post-market clinical follow-up (PMCF): Under the MDR, PMCF is a continuous process requiring updates to the manufacturer’s clinical evaluation, risk management documentation and post-market surveillance plan. The new guidance comes in the form of templates for the PMCF plan and evaluation report, which should be used to manage these updates.
- Ventilators and related accessories: This guidance document sets out the MDCG’s view of the regulatory requirements that apply to ventilators and related accessories. In particular, it outline the options for producing and/or placing these products on the market in the context of the COVID-19 pandemic. While the guidance note is not, therefore, strictly concerned with MDR implementation, it nevertheless provides helpful insight to the MDCG’s approach to clinical evidence requirements under the MDR, which complement the further guidance referred to above. The guidance document also comments on the operation of the national derogation mechanism contained in Article 59(1) of the MDR, which we discussed in our previous blog.