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10. 01.2019

UK to recognize CE Marks for limited time in case of ‘no deal’ Brexit

The UK’s Medicines & Healthcare products Regulatory Agency will continue to recognize CE Marked products for use in the country for a limited time following a ‘no deal’ Brexit scenario, according to new guidance from the agency.

The country’s medtech watchdog recently released updated guidance covering steps it will take if it does not reach a deal with the European Union before March 29, the date it is slated to leave the EU.

The agency said that in the case of a ‘no deal’ scenario, it will continue to recognize CE Mark certifications received before the country exits from the EU for a limited time period.

Manufacturers will not be required to obtain new CE Mark certifications for their devices, but will be required to register the devices with the MHRA after the March 29 exit date, according to guidance documents. Medtech companies will receive a grace period of between four and 12 months to register their devices, depending on the device being registered.

“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. 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 wrote in its recent guidance. “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.”

Devices cleared by UK-based notified bodies, however, will no longer be able to be placed on the European Union markets after March 29, the MHRA said. However, the agency said that it will “give UK-based NBs an ongoing legal status and continue to recognize the validity of certificates that they issued prior to March 29, 2019.”

“This will allow products covered by certificates issued by UK-based notified bodies to continue to be placed on the UK Market after March 29, 2019,” the MHRA wrote.

Last month, UK health minister Matt Hancock released an official posting stating that the UK government is preparing for a “worst-case” Brexit scenario in which no deal is reached between the country and the European Union by March 29.

Source: MassDevice