NEW YORK – The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) recently published a set of guidelines for in vitro diagnostics manufacturers in the event that the UK leaves the European Union without a deal.
British Prime Minister Boris Johnson has reiterated that the UK will exit the EU by the end of the month with or without a deal. If the UK does leave the EU on Oct. 31 without a deal, MHRA will take on the responsibilities for regulating medical devices and IVDs currently overseen by the EU.
"Government guidance has been issued to prepare for a no-deal EU exit, as supported by legislative change where required, should that be the outcome of negotiations between the UK and EU," an MHRA spokesperson said this week.
As detailed in the Sept. 18 document, IVDs and medical devices are currently regulated in the UK under the EU's In Vitro Diagnostics Directive (IVDD) and the Medical Device Directive (MDD). Compliance with the IVDD allows manufacturers to sell their products for clinical use in the UK under a CE-IVD mark. Additionally, the EU is transitioning to new regulations governing medical devices and IVDs, set to come into force by 2020 and 2022, respectively.
MHRA has so far regulated medical devices and IVDs under the EU system. But should the UK leave the EU without a deal covering the regulation of IVDs and medical devices, there will be some changes, according to the agency.
For example, IVD manufacturers will have to register their tests with MHRA from the day the UK leaves the EU. If the manufacturer is based outside the UK, the company will have to have its products registered with the help of a domestic representative, known as a "UK responsible person." Only a UK firm or a responsible person will legally be able to place a test on the market. A person may be an individual or a company, the guidance states.
According to MHRA, manufacturers will have a grace period of several months to a year, depending on the class of the devices, to have their products registered. The fee to register a product is £100 ($123).
MHRA will continue to define IVDs and medical devices according to the European IVDD and MDD, and will transition to the definitions in the new EU regulations in coming years. Likewise, the agency said that it will continue to allow devices to be placed on the UK market that conform with EU regulations following Brexit.
The role of notified bodies
The new guidance also covers the role of notified bodies, the organizations certified by the EU to clear products for clinical use. Currently, several organizations have been certifified to clear medical devices under the MDR, yet so far no NB has been certified to clear IVDs, though several expect to be certified in the next few months.
In the event of a no-deal Brexit, UK-based NBs will no longer be recognized by the EU, according to the guidance, meaning they will no longer be able to certify tests that meet the criteria laid out in European regulations. MHRA recommends that companies wishing to place IVDs or medical devices on the UK market have their tests cleared in an EU member state, after which they will be able to sell their tests in both the UK and the EU.
UK-based NBs will continue to operate in the UK, though, and MHRA said it will continue to recognize the certificates of validity they issued prior to Brexit. Products cleared by the UK NBs while the country was an EU member state will therefore still be recognized by the MHRA after.
In addition to publishing the guidance, an MHRA spokesperson said the agency has reached out to medical device and IVD manufacturers to prepare them for Brexit. These updates have included conferences, webinars, focused industry meetings, and one-to-one meetings with stakeholders, she said.
MHRA officials in the past have said that they intend to transition to the new European regulatory guidelines regardless of Brexit. The regulations have already been enacted in domestic UK law.
"Our role in regulating medical devices and in vitro diagnostic devices does not change," said John Wilkinson, director of devices at MHRA, in a 2017 interview. "Our preparations to implement proposed new regulations for medical devices and IVDs continue."
The British In Vitro Diagnostics Association, which represents IVD manufacturers and distributors in the UK, this week commended the agency for its efforts, given the continued uncertainty around Brexit, including for the release of the new guidance.
"MHRA are being very pragmatic in the face of Brexit," said Doris-Ann Williams, president of BIVDA. "We are hopeful that future regulations for IVDs will mirror the EU regulation." According to BIVDA, roughly 8,500 people are currently employed in the British IVD sector.