Today MPs in the House of Commons vote on Theresa May’s deal, which could result in a no-deal scenario if it is not supported. In the run up to this crucial vote, UK regulators have updated guidance for medical device manufacturers on what to expect if the UK leaves the EU without a deal on 29 March 2019. If this occurs, the closely knit regulatory systems of the EU and UK would dissolve. Instead, the UK would have to develop its own set of rules and requirements for registration, vigilance, clinical trials and compliance.
The Medicines and Healthcare products Regulatory Agency (MHRA) have confirmed that all medical devices will need to be registered with it after 29 March 2019 in a ‘no deal’ scenario. Depending on the device, there will be a grace period of four, eight or 12 months.
"For a time-limited period, we will continue to allow devices to be placed on the UK market that are in conformity with the applicable EU Directive," said the MHRA in its guidance. "Relevant labelling requirements will continue to apply including the requirement for products to carry a CE mark and devices which currently require conformity assessment by a NB must have a valid CE certificate."
The MHRA confirmed, though, that medical devices that have obtained certification from UK-based notified bodies (NBs) will not be able to be placed on the EU market after Brexit in a 'no deal' scenario. Instead, manufacturers would need a notified body registered in the UK to certify products for sale in that country and a second notified body registered in an EU member state to register products in the EU.
However, the regulator stated that it will take steps to ensure UK-certified medical devices can continue to be supplied on the UK market. In addition, it set out a business-friendly approach to labelling requirements for medical device manufacturers from other jurisdictions. "To support the continuity of supply of products to the UK market, we will give UK-based NBs an ongoing legal status and continue to recognise the validity of certificates that they issued prior to 29 March 2019," the MHRA stated. "This will allow products covered by certificates issued by UK-based notified bodies to continue to be placed on the UK market after 29 March 2019."
The duties of the MHRA in terms of regulating medical devices in the UK will expand in a 'no deal' scenario as it will assume responsibility in the UK for regulatory matters that currently fall under the EU's regulatory framework in the UK market. With odds stacked against MPs voting for Theresa May’s Brexit deal today, the ‘no deal’ scenario is an increasingly likely outcome and thus optimising preparations for this situation remains vital.
