The MDR repeals the existing Medical Device Directive 94/32/EEC (MDD). The MDR came into force on 25 May 2017 and, originally, approved medical devices were to have a transition period of three years (until 26 May 2020) to meet the new MDR requirements.
Following the transition period, existing devices on the market were no longer able to rely on certificates of conformity issued under the previous MDD regime due to changes in classification and restrictions. This has increased the demand for conformity assessments under the MDR. Simultaneously, the European Commission and national regulators have been slow to designate notified bodies to carry out MDR conformity assessments. These factors have combined to create a perfect storm and the industry faces the possibility of severe interruptions to the medical devices pipeline.
Medical device companies and health ministers have been lobbying the European Commission for some time to extend this deadline. Before the COVID-19 crisis, the European Commission held its ground and did not agree to the requests to delay the implementation of MDR.
Impact of COVID-19
Once the extent of the COVID-19 crisis became clear, the European Commission proposed that the deadline for the full implementation of the MDR should be extended to 26 May 2021. The EU Parliament and Council subsequently approved this.
According to the European Commission, "a significant number" of notified bodies' designations under the MDD are set to expire in the intervening year. The European Commission further states that it is "essential that notified bodies … are able to continue to operate until the new regulatory framework for medical devices under [MDR] becomes applicable."
However, due to the disruption caused by the pandemic, the on-site assessments and audits typically required for renewing a designation cannot be carried out.
As such, the European Commission says it will allow designating authorities to deviate from normal procedures to renew designations under the MDD regime until MDR takes effect.
Implications for Brexit
The UK left the EU on 31 January 2020 and, pursuant to the UK-EU Withdrawal Agreement 2019, implemented a "Brexit transition period" until 31 December 2020. It also postponed the cut-off date for "retained EU law" (to be preserved in UK law after the transition period) to 31 December 2020.
In effect, the MDR — which was supposed to fall within the scope of "retained EU law" (original implementation date: 26 May 2020) before the delay — now falls out of scope of "retained EU law" after its implementation was pushed back to 26 May 2021.
The current expectation is that the UK government will draft a statutory instrument that aligns the UK's medical device regime with the MDR in the case of a no-deal scenario, to be adopted in Q1 2021.
For now, it seems highly unlikely that the Brexit transition period will be extended past the end of 2020, as the deadline for the UK to request such a deadline passed at the end of June, and although even now an extension could theoretically be agreed, the UK government shows no appetite for one. The UK's chief Brexit negotiator, David Frost, stated in April 2020 that the UK is "not going to ask for an extension and if the EU asks for one, we will not agree to that." However, this topic continues to be full of twists and turns, and we expect more developments soon.