With over 1500 manufacturers and 250k Medical Devices (mostly blood testing, orthopedic, IVD blood testing, cardiovascular and sutures) relying on certificates released by a UK-based Notified Bodies, according to INFARMED (the Portuguese Regulatory Authority), another six months of uncertainty regarding Brexit lay ahead.
A short recap of the events leading up to the current “Brexit situation”, as follows:
- On March 22, 2019, the European Council in agreement with the United Kingdom postponed the withdrawal date of the UK from the EU until May 22, 2019, provided that an Exit Agreement would be approved by the British Parliament by March 29, 2019;
- The European Council agreed on an extension until April 12, 2019, expecting an indication from the UK of the way forward. The UK’s House of Commons failed to reach an agreement;
- On April 11, 2019, following another request from the UK to extend the period provided for in Article 50(3) of the Treaty on the European Union, a new Brexit date was made official by the European Council;
- The new extension will last until the time of ratification of the Exit Agreement, but the deadline is set on October 31, 2019. If an Exit Agreement is ratified before the deadline, Brexit becomes effective on the first day of the month immediately following or on November 1, 2019 (whichever occurs first).
The most recent extension came with a reminder: until Brexit actually comes into effect, the UK is still a member of the EU with full rights and obligations. As such, UK is obliged to hold the European Parliament elections and has to ratify the Withdrawal Agreement by May 22, 2019 otherwise the Brexit extension ceases on May 31, 2019. The European Council will follow-up on UK’s progress at its meeting in June 2019.
Since it will be cut out from the European regulatory network, the UK will have to develop its own system (and processes) to manage UK’s medicines and medical device regulatory activities. Furthermore, the UK will have to inform companies who wish to market their Medical Devices in UK of the regulatory changes they have to implement to comply with the new Regulations in force.
Medical Device manufacturers will have to follow separate device approval processes for EU and UK and appoint a UK Responsible Person.
The day the UK leaves the EU, the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (UK MDR 2019) will amend the UK MDR 2002 to reflect this major change.
Deal or no deal, the day the UK leaves the EU, MHRA (Medicines & Healthcare products Regulatory Agency) will continue to be responsible for the market surveillance of Medical Devices on the UK market and make decisions over the marketing and supplying of a device in the UK, regardless of the position of the European regulatory network.