Jun 9, 2020

While we have reported on the one-year delay of Europe’s Medical Devices Regulation (MDR) due to the COVID-19 pandemic, we have not yet touched on the ramifications that this decision has on countries outside the European Union. The United Kingdom and the nations of the European Free Trade Association (EFTA) are affected due to their close economic and legal ties to the EU, but so are other countries that are working on aligning elements of their regulatory systems with the MDR or participating in data-sharing programs with the EU.

The United Kingdom, EFTA members, and Turkey still on course for national MDR implementation

One of the stipulations of Brexit was that the UK would abide by EU law during a ten-month transition period. For this reason, a national version of the MDR (the UK MDR) was drafted. Now that the revised MDR implementation date falls outside the transition period, the UK’s current trajectory is to allow the UK MDR to come into force in December before the EU follows suit. The Medicines and Healthcare products Regulatory Agency (MHRA) has not provided any indication of whether the UK MDR might be delayed or scrapped, but it has acknowledged the situation and promised to issue guidance at an unspecified time in the future.

The European Free Trade Association (EFTA), whose members are Norway, Iceland, Liechtenstein, and Switzerland, issued a Joint Committee Decision approving the MDR and incorporating it into the European Economic Area (EEA) Agreement. This means that the individual member states are expected to pass their own national versions of the MDR, and this process is already underway. The MDR delay may not have a major impact on these plans, but it potentially opens up the possibility of aligning individual nations’ implementation dates with the new May 2021 target.

Due to bilateral agreements with the EU, Turkey has a similar status to EFTA countries regarding the MDR and is on course to introduce its own national version of the legislation. The Turkish Medicines and Medical Devices Agency (TITCK) has issued an announcement about the MDR delay but has not specified whether it plans to take any actions in response.

Australia may postpone new MDR-aligned SaMD rules

In December 2019, Australia’s Therapeutic Goods Administration (TGA) amended its medical device regulations pertaining to software as a medical device (SaMD). The new regulations were mostly aligned with the MDR and were planned to come into force in August 25, 2020. It has been widely expected that the TGA would push this date back in accordance with the delayed MDR implementation. While the TGA has so far not confirmed this action, it did announce on May 28 that it is analyzing the impact of MDR delay on regulatory timeframes in Australia.

Taiwan extends cooperation program with EU until May 2021

The Taiwan Food and Drug Administration (TFDA) announced the extension of the second version of the Taiwan-EU Technical Cooperation Program (TCP II) for the exchange of Quality Management System (QMS) reports until May 25, 2021. TCP II allows EU-based medical device manufacturers to utilize audit reports and ISO 13485 certificates from designated participating Notified Bodies in order to abbreviate Quality System Documentation (QSD) requirements in Taiwan. The MDR delay will allow TCP II to continue for another year before a replacement program is put into place.

Resources for understanding the MDR and affected markets worldwide:

Author

  • Timothy Herr

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