The "No-Deal" Scenario
With the defeat of the agreement on the withdrawal of the United Kingdom (UK) from the European Union (EU) and the March 29, 2019 deadline approaching, there is a real possibility that the UK will leave without a deal in place. In fact, it is recommended that medical device manufacturers be prepared for a “no-deal” Brexit. So, what does the “no-deal” scenario mean for medical device manufactures?
In the “no-deal” scenario, the UK plans to introduce a new safety mark, the UKCA (UK Conformity Assessed), to replace the EU’s CE Mark. The UK government issued guidance that establishes the UKCA mark for product marking (subject to Parliament approval), if the UK leaves the EU on March 29 without a deal.
However, medical devices are one of three industries called out as a special case: instead of requiring the UKCA mark on medical devices, the UK is going to continue recognizing the CE mark for medical devices and in vitro diagnostic devices (IVDs), for the time being.
UK’s Medicines & Healthcare products Regulatory Agency (MHRA) has confirmed that medical device manufacturers will not be required to obtain new 'CE' markings to continue supplying those devices in the UK, however, the MHRA confirmed that all medical devices, active implantable medical devices, IVDs and custom-made devices will need to be registered with the MHRA after March 29, 2019 in a “no-deal” scenario. The MHRA will have grace periods to allow time for compliance, which will range from between 4 and 12 months, depending on the class of device.
However, the MHRA stated that medical devices that have obtained certification from UK-based notified bodies (NBs) will not be allowed to be placed on the EU market after March 29, 2019 in a “no-deal” scenario, because such certification will no longer be recognized by the EU. This means companies must get products assessed and marked by an EU recognized conformity assessment body to sell the products in the EU.
Additionally, in the “no-deal” scenario, regulatory submissions would be made directly to MHRA. The MHRA will continue to perform national post-market surveillance of medical devices on the UK market, and be able to enforce national decision making over the marketing of a device in the UK. UK law after March 29, 2019 will not require any changes to labeling, and the UK would continue to accept labelling that includes other languages.
The MHRA has adopted an approach that will ensure continuity in the supply of medical device products into the UK for both patients and manufacturers in the “no-deal” scenario.
The future of medical device regulation post-Brexit, however, remains unclear. The MHRA has promised to provide adequate time for manufacturers to implement new regulations (e.g. requiring the UKCA mark on medical devices).
For now, and should be assumed for a time-limited period, in a “no-deal” scenario:
Conformity: Devices that have a CE mark from a Notified Body (NB) based in the UK or an EU country will continue to be recognized by the UK and allowed to be placed on the UK market.
UK Notified Bodies: UK NBs would be given on-going legal status and certificates issues by them would continue to be recognized by the MHRA, but not in the EU.
Labelling: Labelling requirements would not change.
Registration: The current registration requirements would be extended so that all classes of medical device would need to be registered with MHRA before being placed on the UK market, a grace period will exist. If the device manufacturer was not established in the UK, the device would need to be registered by a “UK Responsible Person” in the UK.
MDR/IVDR: The UK would implement the new EU regulations on medical devices (Regulation (EU) 2017/745) (MDR) and in-vitro diagnostic devices (Regulation (EU) 2017/746) (IVDR) on the same timeline as the EU.
Clinical investigations: The UK would continue to recognize existing regulatory and ethics approvals for clinical investigations for devices.
Market surveillance: The MHRA would continue to carry out market surveillance of devices on the UK markets and would be able to take decisions without conferring with the EU regulatory network.