On 17 April 2020, the European Parliament voted to postpone the application of one component of the EU’s new medical devices regime, the Medical Devices Regulation (MDR). Several contingent date changes, affecting transitional periods prescribed within the legislation, were also approved. The proposal for this initiative was first announced by the European Commission on 3 April 2020, and, emphasising it’s particular importance and urgency, was voted on by the European Parliament well in advance of the original end of May deadline. The proposal still requires the approval of all Member States and publication in the Official Journal before coming into full effect. This will necessarily take place before the current, unrevised, date of application of the MDR on 26 May 2020 however. Notably, the date of implementation of the In Vitro Medical Devices Regulation (IVDR) is unaffected, and remains 26 May 2022.
The COVID-19 crisis was cited as the reason for the delay, noting the “unprecedented challenge to Member States”, “an immense burden” for all actors in the regime and the need for industry to focus solely on fighting the pandemic and avoid shortages or delay in supply of critical medical equipment. However, for a long time industry had been advocating for postponement to the new regime, citing a track-record of significant delays and issues with implementation that pre-date the COVID-19 crisis. Regardless of the reason, the delay is therefore likely to be welcomed, even if it does represent a significant setback in EU’s reform of its medical devices regulatory regime.
The most significant changes regarding the MDR’s implementation are as follows:
- 1 year delay of application of the MDR – from 26 May 2020 to 26 May 2021
- 1 year delay of date of repeal of the EU’s existing medical devices regime – from 26 May 2020 to 26 May 2021
- 1 year delay of the date that the European database on medical devices (“Eudamed”) becomes functional – from 25 March 2020 to 25 March 2021
- Required use of the derogation provision (exceptionally relaxing requirements for full conformity assessment requirements for public health interests or similar) within the MDR, rather than the MDD so that the mechanism unique to the MDR can be relied upon to allow the European Commission to make national derogations EU-wide (rather than only national derogations as provided for under the MDD)
- Requiring Member State authorities to notify the European Commission of national derogations granted under the MDD so as to allow extension of said existing derogations Union-wide under the MDR
- Clarification that medical devices placed on the market under the old MDD can continue to be made available until 26 May 2025 (which represents a one day change from the 27 May 2025 date previously provided for)
- 1 year extension of the date that products can be validly placed on the market under the MDD- from 26 May 2020 to 26 May 2021
- 1 year extension of date that notification and conformity assessments performed by existing notified bodies remain valid – from 26 May 2020 to 26 May 2021
- Confirmation that notified bodies can be re-designated prior to 26 May 2021 and those bodies already re-designated can issue certificates prior to 26 May 2021
The announcement marks a significant delay to the overhaul of the medical devices regulatory regime within the EU. Currently, EU medical devices are regulated by laws dating back to 1990. The European Commission cited issues relating to divergence in the interpretation and application of these directives, as well as high-profile incidents of the malfunction of medical devices (such as the PIP breast implants scandal) as reasons for introducing the revised legislation, the MDR. The European Commission also highlighted the need to update the regulatory framework to reflect the technological advances of the past three decades.
The new MDR adopted in 2017 alongside the new IVDR, applies to a wider range of devices, and requires more thorough labelling on all products. The changes in regulatory framework also place more of an emphasis on a life-cycle approach to safety (including the consideration of cybersecurity), and increased traceability and transparency with respect to the medical devices on the market. The MDR also introduces considerable changes to the supervision of notified bodies.
The new regulation also requires notified bodies to submit for re-designation. According to the Commission, 44 of the current 49 notified bodies have applied for re-designation, and fewer have seen the process completed. As a result, many companies do not yet know to what scope (if any) their notified body will be re-designated. For a number of years there have therefore been on-going concerns that there will be too few notified bodies, available too late, covering too few product categories. This has left many companies not knowing whether they need to seek a new notified body in order to prevent their product being removed from the market upon the date of application of the new regulation. This issue, and many others introduced by the legislative regime change, have been amplified by complexities introduced by Brexit.
Further, the pressure of the May 2020 deadline was forcing many companies to make use of a grandfathering clause, enabling products to be re-certified under the old regulatory framework for up to 5 years. This has resulted in concerns of re-certification bottlenecks with notified bodies, as well as an unnecessarily slower uptake of the new regulations.
Whilst the announcement is therefore no doubt welcome, whether precipitated by the COVID-19 crisis or in part due to the on-going issues with implementation, it should not signify a pause in efforts to meet the requirements of the new regime. Instead, the extra time afforded by the announcement should galvanise companies to ‘get ahead’, and ensure that they fully comply with the requirements of EU MDR before the new application date, whilst not forgetting their obligations under the new IVDR whose implementation date remains unaffected. It will also allow the authorities and governments to better implement the necessary infrastructure for the new regime.
For a comprehensive overview of the EU medical devices regime (focusing on liability, but touching upon the new regulatory regime) please read this article, authored by Cooley’s Sarah-Jane Dobson and Rod Freeman, in partnership with Thomson Reuters Practical Law*.
We will continue to keep you updated about the developments in this major overhaul of the medical devices regime in the EU.