Regulating medical devices in the event of a no deal scenario

Yesterday (26 Feb 2019), the MHRA expanded on its previous guidance following its ‘no-deal’ Brexit Preparations for Drugs, Medical Devices (here). Once again, irrespective of how you feel about the shambles being choreographed by Westminster, government bodies are doing their best to pick up the pieces so some semblance of a system remains when 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 new guidance coming from the UK Medicines and Healthcare products Regulatory Agency (MHRA), we are provided with an insight into how medical devices will be regulated in the UK in a no deal scenario. This guidance follows on from the further guidance note published on 3 January 2019.

It is reiterated how, if there is no deal with EU the UK’s current participation in the European regulatory network for medical devices will end, and the MHRA will take on the responsibilities for the UK market currently undertaken through the EU system. 

This guidance provides further detail on getting devices certified, CE marking and registering devices with the MHRA. In the first instance, current EU directives will effectively be transposed into the new UK regulations reworded to reflect the UK’s standalone position. The MHRA will continue to perform market surveillance of medical devices on the UK market and be able to take a decision over the marketing and supplying of a device in the UK, regardless of the position of the European regulatory network, or any post-exit decision of the European Court of Justice.

For those manufacturing and supplying devices, it appears that UK-based Authorised Representatives will no longer be recognised in the EU. This means 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), setting out requirements that a UK manufacturer must meet, will remain. Manufacturers wishing to place a device on the UK market must first register with the MHRA (see the section titled ‘Registrations’ for more information on this). Where a manufacturer is not established in the UK, it must designate a UK Responsible Person (see below) to register and act on its behalf. There are some additional responsibilities for manufacturers but these relate to transposition of relevant EU requirements. 

UK Responsible Person

The new role of UK Responsible Person, acting on behalf of non-UK manufacturers wanting to carry out specified tasks in relation to the manufacturer’s obligations – such as registering a device with the MHRA before it can be sold on the UK market. The UK Responsible Person acting for a non-UK manufacturer needs to be based in the UK and able to demonstrate documentary evidence supporting the position (letter of designation or signed contract) and you must maintain certain information such as declarations of conformity and technical documentation. 

Importers

Entities within the UK that place devices from a country outside on the UK on the market will be defined as ‘Importers’ and they will be required to ensure that 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 also noted that from Brexit Day parallel importing from the EU into the UK will not be possible. Any device that is imported from the EU and placed on the UK market will be treated as a new placing on the market, with all of the relevant manufacturer requirements applying to this 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 known as ‘Distributors’ and they will be required to ensure that products are ‘safe’ through 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 caused by an unsafe product. 

Medical device classification

Currently, there are three main types of devices: a medical device, an active implantable medical device, or an in vitro diagnostic medical device (IVD) – this may change slightly in the future and manufacturers are provided with links to more detailed definitions. In terms of IVDs, a new classification system will be introduced with the aim of classifying IVDs based on risk. Seven new classification rules will come in force in the EU from 26 May 2022, with IVDs being classified into four risk classes. In addition, 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 also 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 as they are at present. Manufacturers will continue to need robust data to support claims made for all types of medical devices. However, from 2020 there will be increased requirements for clinical evidence in the EU, including an expectation for higher risk devices that clinical investigations specific to a device be performed.

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 are not expected to be recognised by the EU and therefore, devices they have certified will no longer be in conformity with the applicable EU Directive. The lack of CE certification means that these devices will not be legal for the EU market and an EU certificate will be needed.

UK-based Notified Bodies will be given an on-going legal status and continue to recognise the validity of certificates in the UK that they issued prior to 29 March 2019. This will allow devices covered by certificates issued by UK-based Notified Bodies to continue to be placed on the UK market.

After 29 March 2019, all medical devices, active implantable medical devices, IVDs and custom-made devices will need to be registered with the MHRA prior to being placed on the UK market. Grace periods of 4 – 12 months are currently being given 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 continually monitor the safety and performance of their device. The manufacturer must submit vigilance reports to the MHRA when certain incidents occur in the UK involving their device and take appropriate safety action when required.

It remains to be seen what impact this will have on UK device manufacturers but initial indications are that they face more paperwork if they want to continue to do business in the EU.

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