How medical devices are currently regulated
All 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 IIa, IIb and III medical devices and in vitro diagnostic devices (IVDs) in List A and List B of Annex II of the IVDD) must be certified by an independent conformity assessment body - Notified Body (NB).
NB’s are monitored by their national authority, following a process of designation which involves joint audits by two other national authorities and the European Commission.
BREXIT – if ‘no deal’
If there’s no deal, the UK’s current participation in the European regulatory network for medical devices would end. The MHRA (as competent authority) would take on the responsibilities for the UK market.
Conformity of products
For a time-limited period, the UK will continue to allow devices to be placed on the UK market that are in conformity with the applicable EU Directive. Relevant labeling 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 BREXIT process for bringing a medical device onto the UK market is not clear.
If there’s no deal, UK-based NB’s will no longer be recognized by the EU after 29 March 2019! The medical devices certified by UK-based NB’s 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!
MHRA (UK competent authority) will continue recognize the validity of certificates of UK-based NB’s 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.
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.
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 (CJEU).
If there’s no deal, the UK (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.
New EU regulations (MDR/IVDR)
Through the no deal statutory instrument, which will amend the Medical Devices Regulations-UK per 30 March 2019, which will mirror all 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.
Registration of medical devices on the UK market
After 29 March 2019, all medical devices, active implantable medical devices, in vitro diagnostic medical devices (IVDs) and custom-made devices will need to be registered with the MHRA (UK) 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:
Class III medical devices, Class IIb implantable medical devices, Active implantable medical devices, IVD List A
Class IIb non-implantable medical devices, Class IIa medical devices, IVD List B, Self-test IVDs
Class I 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 III 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 all products.