Medical Device News MHRA to consult on EU exit no-deal legislative proposals

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dgrainger

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Click through to here: Introduction - Department of Health and Social Care - Citizen Space
(Documents at the bottom of the page)
It covers all the legislation MHRA implements, but the summary proposal for Devices is:

ANNEX IV: NARRATIVE ON CHANGES TO MEDICAL DEVICES LEGISLATION
Technical information for industry that is not being consulted on but provided for information

1. A new ‘UK mark’ to replace or run alongside the CE mark could be developed in future, but not for Exit day. A new ‘UK mark’ and/or other agreed international ‘marks’ could replace or supplement CE marks as indication of conformity with UK requirements.

2. New EU Devices Regulations
Elements of the new EU Devices Regulations have been applied directly in UK law since May 2017, meaning devices, including IVDs, can now be legally placed on the UK market if they are in conformity with the new Regulations, invoking all relevant requirements. In addition, during the implementation period agreed with the EU, the EU Medical Devices Regulation will be fully applied from May 2020. This would not automatically follow for the new EU Regulation for in vitro Diagnostic Medical Devices, which does not apply until May 2022.
Under the EU (Withdrawal) Act, Section 4(1) preserves “rights, powers, liabilities, obligations, restrictions, remedies and procedures, so far as they are recognised, available and followed immediately before exit day” as domestic law. Therefore, upon exit under a no-deal scenario, the UK would retain this dual regulatory framework, and medical devices could be placed on our market (and put into service) either in conformity with the current requirements (based on EU Directives) or in conformity with the requirements derived from the new EU Regulations.
The UK would comply, and align UK law with, with all key elements of the Medical Devices Regulation (MDR) and the in vitro diagnostic Regulations (IVDR) - which will apply in the EU from May 2020 and 2022 respectively – subject to the usual parliamentary approvals.

3. Notified Bodies
The MHRA will be unable to designate UK conformity assessment bodies as EU notified bodies. Existing UK notified bodies for medical devices would need to transfer functions to EU27.
 
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