There are now only two months to go before the date of application of the Medical Devices Regulation (MDR) on 26 May 2020. We have previously published updates on various implementation activities, and the concerns of industry and stakeholders that the deadline has been fast approaching but that there remains a huge amount to be finalised. The difficulties surrounding Brexit, and now the coronavirus pandemic, only add to these concerns. With the short amount of time remaining, we set out in this series of posts a summary of recent key developments.
As expected, the recent activity is focused on the MDR, and does not, on the whole, address the In Vitro Diagnostics Regulation (IVDR), which is due to be applicable in 2022. While this is a pragmatic approach from the institutions given current timing, it remains the case that IVD manufacturers have little clarity on how the IVDR will operate, and it seems, are unlikely to obtain any in the near future.
Joint implementation/preparedness plan on the MDR
Earlier this month, the Medical Device Coordination Group (MDCG) issued a joint Commission and Member State implementation/preparedness plan on the MDR (the Plan), which sets out key shorter-term priority areas and actions that are being put in place to ensure that the MDR is operational by 26 May 2020. This Plan complements the Commission’s rolling plan (most recently updated in December 2019), which contains a list of the essential implementing acts and actions that need to be introduced.
The key areas addressed by the Plan are:
- EUDAMED: As we have previously reported, the launch of the EUDAMED database has been delayed until 2022. According to the Plan, the Commission and Member States are in the meantime “working closely to identify harmonised administrative practices and technical solutions to facilitate the exchange of information until EUDAMED is functional”. The Commission intends to deliver the “actor registration module” by May 2020, allowing economic operators to obtain a Single Registration Number (SRN) once the relevant competent authority has verified and executed the registration request. The MDCG will issue accompanying guidance on this process.
- Placing safe devices on the market after 26 May 2020: A concern that has been repeatedly raised by industry is the potential risk of supply disruptions of critical medical devices due to the lack of capacity within the notified bodies. In order to minimise disruption, the Plan refers to the MDR’s transitional provisions and the possibility of national derogation under article 59 MDR to reduce some of the administrative burdens of the Regulation. The Plan notes that guidance on the use of the Article 120 transitional period, including for some Class I device manufacturers, should be published as a priority; these guidance notes have since been published and will be discussed later in this series.
- Clinical evaluation and Expert Panels: The Plan confirms that MDCG guidance on legacy medical devices and on equivalence for well-established technologies is a priority, meaning that we should see this published before 26 May 2020. In addition, expert panels (which, under the MDR, are intended to provide scientific, technical and clinical assistance to various parties, including manufacturers) will be established before 26 May 2020. The Plan suggests that the tasks of the panels will initially be limited to the clinical/performance evaluation consultation procedures, and that other functions (such as ad hoc advice) will be progressively phased in over subsequent years.
- Implementing acts: The Plan states that the ‘Implementing Decision on a standardisation request to CEN/CENELEC for MDR/IVDR harmonised standards’ and the ‘Implementing Regulation on Common Specifications for the reprocessing of single-use devices’ are “expected to be adopted before 26 May 2020”. The implementing act on devices without an intended medical purpose is stated to be “in the pipeline”, although no precise timeline is given.
In addition, on 18 March, the Commission issued an updated overview on the state of play of joint assessment of notified bodies in the medical device sector. Out of the total of 58 applications for designation that have been made, there are currently only 11 designated notified bodies under the MDR (although a 12th has since been designated), and 3 designations under the IVDR. The Plan acknowledges that the current lack of notified body capacity may lead to short-term supply chain disruptions. However, the Plan also states that “it can be reasonably estimated that the number of designated notified bodies will significantly increase in 2020”.
While all of these action points will be welcomed by industry, the lack of concrete timeline for many, and the short amount of time before May, will mean the intentions of the Commission will offer little comfort to manufacturers. In particular, a recent survey from MedTech Summit, a leading EU industry medical device conference organiser, notes that only 17% of respondents think that their company is ‘fully prepared’ for EU MDR implementation; the lack of guidance or clarity on key aspects of the Regulation is noted as a factor in the majority of the responses, and 66% of respondents stated that they required guidance from the Commission in order to be fully prepared for implementation.
Current market realities…
There are of course factors outside the Commission’s control that may, or will, impact the implementation of the MDR. In particular, the current COVID-19 outbreak is likely to further delay notified body assessment. This was alluded to by the European Association Medical Devices – Notified Bodies in its statement of 12 March, where it noted that “The outbreak is having an impact on the implementation of both regulation MDR 2017/745 and IVDR 2017/746 due to travel restrictions.” MedTech Europe, the European wide industry body for medical device companies, has called for a pause on the implementation of both the MDR and IVDR to facilitate the fight against COVID-19. This has been echoed by national industry bodies around the EU, including the ABHI in the UK.
The pandemic has also shown how the national derogation provisions under Article 59 of the MDR could be used. A Commission Recommendation of 13 March 2020 recommends, among other things, use of this provision to loosen the conformality assessment and market surveillance procedures under the MDR to support the response to the COVID-19 pandemic. For example, in relation to the conformity assessment procedure, this states that “the possibility for Member States to authorise derogations from conformity assessment procedures should also be considered, according to Article 11(13) of Directive 93/42/EEC and Article 59 of Regulation (EU) 2017/745 once the latter becomes applicable, also when the intervention of a notified body is not required.” This power rests with the Member States, rather than the Commission, but there have already been comments that these provisions could be used if a large number of devices are removed from the market after May as a result of non-conformity with the MDR.
The other factor is of course Brexit, even if it may have faded from focus given the current public health crisis. The negotiations on the future relationship between the UK and EU have not yet begun. With both sides increasingly, at least before this month, standing by their entrenched position, the outcome of these negotiations, and what this means for industry, is far from certain, with even the most basic of mutual recognition provisions seemingly not guaranteed.
While the Commission is sticking to the May 2020 date of application, this is looking increasingly untenable.