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2019-01-04 From GOV UK : Guidance note on the regulation of medical devices if there’s no Brexit deal

BREXIT: What will happen after March 29, 2019 in case of no deal ?

Note: For medicines (part 1) and Clinical trials for medicinal products (part 3), see the link at the bottom of this page)

2. Medical Devices

2.1 How medical devices are currently regulated

ln the UK, ail medical devices are subject to EU legislation, which requires a manufacturer to place a CE mark on their product to attest compliance to applicable standards. Medical devices are regulated under Directive 90/385/EEC on active implantable medical devices, AIMDD), Directive 93/42/EEC on medical devices (MDD) and Directive 98/79/EC on in vitro diagnostic medical devices (IVDD). These directives are transposed into UK law as the Medical Devices Regulations 2002.Manufacturers of low risk devices (Class I medical devices) can self-declare conformity to the legislation before affixing the CE mark. Higher-risk devices (such as Class lIa, lIb and Ill medical devices and in vitro diagnostic devices (IVDs) in List A and List 8 of Annex Il of the IVDD must be certified by an independent conformity assessment body, called a Notified Body (NB) before the CE mark can be affixed. NBs are monitored by their national authority (the MHRA in the UK), following a process of designation which involves joint audits by two other national authorities and the European Commission.

2.2 How we propose to regulate medical devices if there’s no deal

If there’s no deal, the UK’s current participation in the European regulatory network for medical devices would end, and the MHRA would take on the responsibilities for the UK market that are currently undertaken through the EU system. This section provides further detail on how we propose the UK system would operate.

2.3 Conformity of products

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.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.If there’s no deal, UK-based NBs will no longer be recognized by the EU after 29 March 2019, meaning the devices they have certified will no longer be in conformity with the applicable EU Directive. As such these products will not be able to be placed on the EU market.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 recognize the validity of certificates that they issued prior to 29 March 2019. 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 ail UK requirements.

2.4 Clinical investigations

The UK will continue to recognize existing clinical investigation approvals- both for regulatory and ethics approvals - and there will be no need to re-apply. UK clinical investigation applications will continue to be authorized by the MHRA and ethics committees as they are presently.

2.5 Market surveillance of devices

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 (C.JEU).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 C.JEU.

2.6 New EU regulations

Through the no deal statutory instrument, which will amend the Medical Devices Regulations 2002, the UK will have a regulatory system in place on 30 March 2019, which will mirror ail the key elements contained in Regulations 2017/745 on medical devices (MDR) and 2017/746 on in vitro diagnostic medical devices (IVDR) and which will be brought into force in line with the transitional timetable being followed by the EU for the full application of those two Regulations.

2.7 Registration of medical devices on the UK market

After 29 March 2019, ail medical devices, active implantable medical devices, in vitro diagnostic medical devices (IVDs) and custom-made devices will need to be registered with the MHRA prior to being placed on the UK market.Given this is an extension of existing registration requirements, there will be a grace period to allow time for compliance with the new registration process as set out below:

4 months : Class Ill medical devices, Class lIb implantable medical devices, Active implantable medical devices, IVD List A

8 months : Class lIb non-implantable medical devices, Class lIa medical devices, IVD List B, Self-test IVDs

12 months : Class 1 medical devices, Self-certified IVDs, Class A IVDS

Registration for custom-made devices will be in line with the risk class of the device. The registration requirements will be as follows:

• initially the MHRA will require most products to be registered at the level of Global Medical Device Nomenclature (GMDN) code meaning that groups of similar products can come under a single registration. The exception is class Ill devices, which must have individual product information registered

• once the MDR and IVDR fully apply (from May 2020 and May 2022 respectively), the UK will then mirror the new requirements within the legislation, which will mean individual registration of ail products

Where a device manufacturer is not established in the UK, registration of a product with the MHRA must be undertaken by a ’UK Responsible Person’ established in the UK and with a UK registered address who will take responsibility for the product in the UK. No labelling changes will be required to reflect the role of this ’UK Responsible Person’.

Full text at: https://www.gov.uk/governmentlpubli... medical-devices-and-clinical-trials-if-theres-no-brexit-deal

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