Out-Law News | 09 Jan 2019 | 4:56 pm | 3 min. read
In newly updated guidance, on the regulation of medicines, medical devices and clinical trials in the event of a 'no deal' Brexit, the MHRA confirmed that all medical devices, active implantable medical devices, in vitro diagnostic medical devices (IVDs) and custom-made devices will need to be registered with it after 29 March 2019, the date the UK is scheduled to leave the EU, in a 'no deal' scenario.
The MHRA has outlined a grace period for registration of four months, eight months or 12 months depending on the device. It also confirmed that "existing clinical investigation approvals – both for regulatory and ethics approvals" would continue to be recognised in a 'no deal' scenario and that CE certifications obtained before the UK leaves the EU would continue to be accepted in the UK for a limited time.
"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," the MHRA said 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."
"Further detail on the future process for bringing a medical device onto the UK market will be subject to consultation in due course. For any future changes to requirements, adequate time will be provided for businesses to implement these," it said.
"It will be important in any future process that any divergence from the EU CE marking system is kept to a minimum," said Helen Cline, an expert in life sciences at Pinsent Masons, the law firm behind Out-Law.com.
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 as such certification "will no longer be recognised by the EU" as they will be deemed to "no longer be in conformity with the applicable EU Directive".
However, the regulator said it will take steps to ensure UK-certified medical devices can continue to be supplied on the UK market. It also 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 said. "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."
"UK law will not require any changes to the labelling of affected products. Furthermore, the UK will continue to accept labelling in the English language, which includes information from other jurisdictions (such as Ireland), on condition that information complies with all UK requirements," it said.
"The MHRA has adopted a pragmatic approach," said Cline. "These clarifications go some way to ensuring a continued and timely supply of medical technology into the UK for both patients and manufacturers whatever the outcome of the political wrangling in the coming weeks."
Cline said that medical device manufacturers should be preparing for a 'no deal' Brexit.
She said: "Although there is still some degree of optimism that a deal will be agreed, the day to day developments over the past few weeks mean that there is still uncertainty over what the UK-EU relationship will look like after 29 March. Therefore, for an industry that supplies significant quantities of life saving medical technology to the NHS through Europe, the best advice at the moment is to prioritise planning for a 'no deal' Brexit."
The duties of the MHRA in respect 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. In its new guidance, the MHRA explained how market surveillance of devices would change.
"Currently, post-market safety data is shared across all members of the European regulatory network for devices (EU, EEA, Turkey and Switzerland), and any disagreement over the marketing of a device can be escalated through regulator forums such as the Medical Devices Coordination Group, and potentially through the European Commission and Court of Justice of the European Union (CJEU)," the MHRA said.
"If there’s no deal, the MHRA would continue to perform market surveillance of medical devices on the UK market and be able to take a decision over the marketing of a device in the UK, regardless of the position of the European regulatory network, or any decision of the CJEU," it said.