MDR postponement
Additional MDR preparation
Time extensions versus shorter transition periods
IVDR


MDR postponement

In light of the COVID-19 pandemic's impact on medical device industry players (eg, manufacturers, notified bodies, suppliers, production sites and research institutions), on 25 March 2020 the European Commission announced that it intends to postpone the application date for the EU Medical Device Regulation (2017/745) (MDR) from May 2020 to May 2021. The decision was reached with patient health and safety as a guiding principle.

On 3 April 2020 the European Commission published a proposal to postpone MDR applications to 26 May 2021. As the former deadline had been 26 May 2020, the commission submitted this proposal to allow the European Parliament and the European Council to adopt it quickly.

The European Council agreed to the MDR postponement on 7 April 2020 and the European Parliament followed suit on 17 April 2020, issuing the following statement:

Given the current pressure on national health authorities and manufacturers of medical devices, there is a fear that there could be shortages or delays in getting the medical devices needed to fight COVID-19, were they to follow the new rules of the MDR from May 2020. The European Parliament is therefore supporting the proposal to postpone the application of this regulation by one year to allow authorities and manufacturers alike to prioritise the fight against the coronavirus pandemic by continuing under current procedures.

Additional MDR preparation

The MDR postponement relieves pressure on national authorities, notified bodies, manufacturers and other industry players, as it allows them to focus on urgent priorities relating to fighting COVID-19. Further, it is an important step towards helping patients and the healthcare system during the COVID-19 crisis. Medical devices can be sold for another year under the current regulatory framework based on the EU Medical Device Directive (93/42/EEC) (MDD) and local implementing laws throughout the European Union.

The additional year is a chance for the medical device industry and regulatory bodies to ensure that they are 'MDR ready' in spite of the COVID-19 pandemic.

According to the latest surveys from Autumn 2019, less than 30% of manufacturers had expected and intended to be ready for the MDR in May 2020, while a majority intended to meet the MDR requirements by using transitional periods (ie, by May 2024 at the latest). However, manufacturers still face challenges, including:

  • the re-classification of their devices,
  • remediating and updating technical files and clinical evaluation reports; and
  • implementing MDR-required changes to their quality management systems.

From a regulatory perspective, structural difficulties with the MDR's implementation remain, despite the postponement. Further, in view of the COVID-19 pandemic, such difficulties could now be even more difficult to solve. For instance:

  • MDR certifications of notified bodies are not being conducted. The EU authorities aimed to have 20 notified bodies MDR certified by the end of 2019; however, only 12 have been certified to date.(1)
  • So far, notified bodies have focused on extending old certificates due to COVID-19-related restrictions (eg, regarding travel). It remains unclear whether MDR certifications of new products will continue after the pandemic or whether current COVID-19-related restrictions will be abandoned. If the restrictions remain in force for a long time, in view of the May 2021 deadline, this could result in capacity problems associated with new product certifications.
  • The European database on medical devices, Eudamed, is still not functional and its establishment has been postponed to 2022.

Time extensions versus shorter transition periods

The European Parliament's decision merely postpones the start of the application of the MDR by one year. However, contrary to what the medical industry had lobbied for, transition and sales periods have not been postponed. In fact, these periods remain as before and thus have been effectively shortened from four to three years. The final date of any transitional periods remains 26 May 2024.

The COVID-19 pandemic has made the goal of the MDR implementation no less challenging. In particular, guidelines published by relevant regulatory bodies on temporary exceptional measures relating to audits during the COVID-19 crisis seldom foresee remote audits for new certifications or certifications for purpose extensions of products. Therefore, it remains unclear when regular on-site audits can be carried out again – particularly for such purposes – thereby shortening the transition period for certain products.

IVDR

The European Parliament has issued no similar decision on the EU In Vitro Diagnostic Regulation (2017/746) (IVDR). Although this regulation has a longer implementation time, diagnostic manufacturers and authorities must prepare for major changes and requirements to adapt to the new framework. Their current capacity is also focused on the task of keeping critical diagnostic tests available, despite the production and distribution challenges created by COVID-19.

The industry requested a similar approach for the IVDR when the EU Commission announced the proposal to postpone the MDR application deadline. However, as the European Parliament's decision covers only the MDR, the IVDR is still scheduled to come into force on 26 May 2022.

For further information on this topic please contact Magdalena Kotyrba or Tobias Maier at Eversheds Sutherland (Germany) LLP by telephone (+49 89 54565 0) or email ([email protected] or [email protected]). The Eversheds Sutherland (Germany) LLP website can be accessed at www.eversheds-sutherland.com.

Endnotes

(1) See here.