Yesterday (26 Feb 2019), the UKs Medicines and Healthcare products Regulatory Agency (MHRA) expanded on its previous guidance following its ‘no deal’ Brexit Preparations for Drugs, Medical Devices (here). Irrespective of how you feel about the shambles being choreographed by Westminster, the agency is doing its best to pick up the pieces, ensuring that some semblance of a workable system remains once the dust finally settles.

Once you strip out the 1984-esque, Orwellian ‘newspeak’ (“Leaving the EU with a deal remains the Government’s top priority”) from the MHRAs new guidance, we are provided with some insight into how medical devices will be regulated in the UK following the no deal scenario. The guidance follows on from the somewhat superficial note published on 3 January 2019. Once again it is noted how, if no formal agreement can be established with EU, the UK’s continued participation in the European regulatory network for medical devices will come to an end. At this point the MHRA will take on future responsibilities for the UK market that are currently managed via the EU system. Further details are provided on how to get devices certified, CE marking and the registering of devices with the MHRA. At the outset, existing EU directives will effectively be transposed into the new UK regulations, with text reworded to reflect the UK’s standalone position. The MHRA will continue to perform market surveillance of medical devices within the UK market and it will enforce decisions over the marketing and supplying of a devices, irrespective of the position or opinions given by the European regulatory network, or any post-exit decisions made by the European Court of Justice.

For companies manufacturing and/or supplying devices, it seems that UK-based Authorised Representatives will no longer be recognised in the EU. Consequently, they will need to establish a new Authorised Representative in an EU country. The existing Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002), that sets out the requirements UK manufacturers are required to meet, will remain. Manufacturers looking to introduce a device on the UK market will first need to register with the MHRA (see ‘Registrations’ for more information). When a manufacturer is not established in the UK, it will need to designate a UK Responsible Person (see below) in order to register and act on its behalf. There are additional responsibilities for manufacturers but these relate to transposition relevant to EU requirements.

The UK Responsible Person

The new position of UK Responsible Person, acting within the borders of the UK on behalf of non-UK manufacturers looking to carry out specified tasks in relation to the manufacturer’s obligations – such as registering a device with the MHRA before it can go on sale in the UK. A UK Responsible Person acting for a non-UK manufacturer must be based in the UK and able to provide documentary evidence that supports the position (e.g., a letter of designation or signed contract). The UK Responsible Person must maintain key information such as declarations of conformity and documents describing the technical specifications.

Importers

Entities within the UK that bring devices from countries outside the UK to the UK market will be defined as ‘Importers.’ As such, Importers will be required to demonstrate that these products are ‘safe’ by:

• Warning consumers about potential risks and providing information to help consumers understand the risks
• Monitoring product safety and forwarding complaints or reports of suspected incidents to manufacturers
• Taking action if a safety problem is found, including co-operating with the manufacturer concerning any Field Safety Corrective Actions Request copies of manufacturer’s declaration of CE conformity (where marked)

It is noted that from ‘Brexit Day,’ parallel importing from the EU into the UK will no longer be possible. Devices imported from the EU to be placed on the UK market will be treated as ‘new’ entities, with all of the relevant manufacturing requirements applying to the importer, including the requirement to register the device with the MHRA and engaging a UK Responsible Person.

Distributors

Entities within the UK that play roles in the ‘supply chain’ of a device (other than the manufacturer or the importer) in the UK market will be identified as ‘Distributors.’ The Distributors will be required to ensure that products are ‘safe’ and adhere to the same requirements as those of Importers, although Distributors (e.g., shops and wholesalers) are not normally liable for harm to consumers or their property that might be caused by an unsafe product.

Classification of medical devices

There are currently three main device types: a medical device, an active implantable medical device, or an in vitro diagnostic medical device (IVD) – it is possible that these classifications may change slightly in the future, at which point manufacturers will be provided with links to more detailed definitions. In terms of IVDs, a new classification system will be introduced with a view to classifying IVDs based on risk. Seven new classification rules will come into force in the EU from 26 May 2022, at which point IVDs will be sub-divided into four risk classes. Devices without a medical purpose but with similar risk to medical devices, such as non-corrective contact lenses, will be classified as medical devices.

The new guidance notes that the UK will continue to recognise 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 authorised by MHRA and ethics committees in the same way that they are at present. Manufacturers will continue to need robust data to support claims made for all types of medical devices. From 2020 however, there will be increased requirements for clinical evidence in the EU, including an expectation with devices considered to be of higher risk that data from clinical investigations specific to a device be provided.

The current EU CE marking requirements have been incorporated into UK law under the provisions of the EU (Withdrawal) Act 2018 by the UK MDR 2002 (as amended by the UK MDR 2019). However, from 29 March 2019, UK-based Notified Bodies that provide CE accreditation will not be expected to be recognised by the EU. Therefore, certified devices will no longer be in conformity with the applicable EU Directive. The lack of CE certification means that sale of such devices will not be legal in the EU market and additional EU certification will be necessary.

UK-based Notified Bodies will be appropriated an ‘on-going’ legal status whereby they will continue torecognise the validity of certificates in the UK that they issued before 29 March 2019. This will permit devices covered by certificates issued by UK-based Notified Bodies to continue to be sold in the UK market.

After 29 March 2019, all medical devices, active implantable medical devices, IVDs and custom-made devices will require registration with the MHRA prior to appearing on the UK market. Grace periods of 4 – 12 months are currently being extended to existing devices depending on their classification. Once a medical device has been placed on the UK market in compliance with the applicable legislation, the manufacturer must continue to monitor the safety and performance of their device. The manufacturer will be required to submit vigilance reports to the MHRA when certain incidents occur (in the UK) that involve their device as well as taking appropriate safety actions when required.

It remains to be seen to what extent these changes will impact on UK device manufacturers, but initial indications are not good. It is clear that, in the least, they will face additional paperwork if they want to continue to do business in the EU, at worst manufacturers may need to conduct additional work at their own expense. Simply put, Brexit once again emerges as a colossal mistake.