Erik Hansson, the European Commission’s deputy head of devices, was an expert panelist at the Regulatory Affairs Professionals Society’ 2020 Euro Convergence. The plenary, held on 26 October 2020, discussed global perspectives on the 2020 regulatory landscape with 16 other regulatory experts from organizations including government agencies, notified bodies and manufacturers. Hansson leads the European Commission’s operational team dealing with the implementation of the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), that will manage the changes recently deferred to 2021, and the coordination between EU member states and other stakeholders.

The European Parliament and Council approved the proposal to delay the full implementation of the Medical Device Regulation 2017/745 (MDR) for one year to 26 May 2021. This means that the full applicability of the MDR will fall outside of the transition period agreed with the EU.

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.

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. The MHRA state ‘We are taking steps to plan for after the end of the transition period.

The Regulations ‘entered into force’ on 25 May, which is when the three- and five-year transition periods began. Therefore, the MDR and IVDR will fully apply in EU Member States from 26 May 2021 and 2022 respectively, as shown below.

The MHRA will provide guidance on this in due course in light of Government decisions required on the future of UK regulation, which will also be impacted upon by Brexit. All decisions on regulations will be taken with a view to prioritising patient safety and ensuring patient access for medical devices. In the meantime, the existing regulatory requirements should continue to be met.

Sources:

www.raps.org   www.supplychain.nhs.uk   www.med-technews.com   www.gov.uk