Maurits Lugard, partner, and Josefine Sommer, senior associate and Anouchka Hoffman, associate, at Sidley Austin examine the consequences that come with the delay of the application of EU Medical Devices Regulation by one year.
On April 24, 2020, the EU legislator published an amendment to the EU Medical Devices Regulation (MDR) (Amending Regulation), postponing the application of most of its provisions by one year, until May 26, 2021. The medical devices industry has been eagerly awaiting the adoption of the European Commission’s (Commission) proposal to postpone the application of important parts of the MDR by one year.
Moved Date of Application
The MDR was supposed to repeal and replace the EU Medical Devices Directive (MDD) and the EU Active Implantable Medical Devices Directive (AIMDD) in just one month, on May 26, 2020. The MDR introduces a long list of new obligations for the medical devices industry but its implementation has been slow and affected by delays and uncertainties. The Amending Regulation defers the application of most provisions of the MDR until May 26, 2021.
This postponement will provide much-needed relief to the medical devices industry and the EU Member States for which the ongoing COVID-19 pandemic constitutes an immense burden. The public health crisis has created a demand for substantial additional resources, as well as an increased availability of important medical devices such as medical gloves, surgical masks, equipment for intensive care and other medical equipment.
The prolonged transitional period aims to prevent potential shortages of medical devices that would comply with the MDD or AIMDD requirements but have not yet been certified under the MDR. The medical devices industry will also have one additional year to obtain MDD or AIMDD certificates from their Notified Bodies that will be covered by the transitional provisions of the MDR.
For the medical devices industry, the new dates of application means:
- Extension of National Derogations at EU Level. The Amending Regulation modifies Article 59 of the MDR. This Article empowers EU Member States to authorise non-CE- marked medical devices on their territories in the interest of public health or patient safety or health. The Commission can, in exceptional cases and for a limited period of time, extend the validity of such national authorisations to the entire EU market via a Union-wide emergency procedure. The Amending Regulation makes this EU-wide emergency procedure applicable immediately and makes it applicable to decisions taken under Article 11(13) of the MDD as well. It also allows Article 59 of the MDR to apply to national authorisations under Article 11(13) of the MDD adopted prior to the adoption of the Amending Regulation. This means that companies that have already obtained a national authorisation will be able to benefit from Article 59. Overall, the Union-wide emergency procedure aims to make certain devices available faster than they would otherwise be possible.
- Eudamed – Moving Target. The Amending Regulation modifies Article 34(1) of the MDR, indicating that Eudamed will be fully functional by March 25, 2021. It is still unclear however, whether Eudamed will in fact be operational in all but a year. In December 2019, the Commission indicated that Eudamed will go live on the date of application of the EU In Vitro Diagnostics Medical Devices Regulation (IVDR) on May 26, 2022. Some clarification from the Commission as to when economic operators can expect Eudamed to be functional would be welcome.
- Designation of Notified Bodies. The postponement of the application of the MDR will provide the Commission and the EU Member States one additional year to accredit Notified Bodies under the MDR. The Amending Regulation also gives additional time to Notified Bodies to conduct conformity assessments under the MDR in order to issue MDR certificates and (re)new MDD and AIMDD certificates that can then benefit from the MDR’s transitional provisions.
However, one should not rejoice too quickly. Notified Bodies will likely focus on issuing MDR certificates and renewing only those MDD and AIMDD certificates for which an assessment is already ongoing, rather than accepting new applications for MDD and AIMDD certificate renewals. Generally, any certification will also be extremely challenging during a pandemic, even though Notified Bodies are now allowed to perform remote audits under certain conditions (see Medical Devices Coordination Group’s Guidance 2020-4 on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions). In essence, the postponement of the application of the MDR by one year will likely not create much, if any, extra capacity with the Notified Bodies.
- Shortened Sell-off Period. The Amending Regulation does not change the end date of the sell-off period (i.e., May 26, 2025). The MDR will still provide that medical devices lawfully placed on the EU market, pursuant to the transitional provisions, may continue to be made available on the EU market or put into service only until May 26, 2025. This means that economic operators will have one year less to sell off the medical devices that were made available on the EU market before the MDR’s date of application.
- Entry Into Force. The Amending Regulation will enter into force today, the date of its publication in the Official Journal of the European Union.
- Date of Application of IVDR. To date, the Commission has not published a proposal to defer the application of certain provisions of the IVDR, including its Article 54 which is similar to Article 59 of the MDR.
Industry should take advantage of this additional year to plan for a fully coordinated and comprehensive implementation of the MDR. A complete implementation includes:
- considering necessary changes to the quality management system, including implementation or review of current procedures
- reviewing the existing supply chain, including whether any parts of your supply chain will have new obligations, and reviewing existing contracts with vendors, suppliers etc., to reflect these new obligations
- undertaking an assessment of your devices’ classification under the new classification rules to make sure your device continues complying with applicable rules
- updating your technical files, in particular considering whether additional clinical data may be required for your MDR certification, and preparing a strategy for updating your technical files where you have identified gaps
- reviewing your post-market surveillance and vigilance systems in light of the new requirements, including undertaking a robustness check of your devices’ risk management plans
