Medical Devices

• Determining whether medical device regulations apply to products (and subsequent compliance obligations).
• Technical file and certification documentation requirements, including third-party approved body certifications.
• UKCA (UK Conformity Assessed) and CE marking requirements.
• Correct product labelling, including details of manufacturers, importers and authorised representatives in the UK and EU.
• Current extensions to the UK standstill period and the subsequent legal requirements when new legislation is revealed.
• The role of economic operators in supply chains and subsequent obligations (as well as how to structure relationships to minimise obligations).
• Contract specification requirements (for example, when engaging with suppliers).
• Regulator engagement and enforcement actions.
• Due diligence and post-completion corrective actions.

Our experienced medical device and regulatory compliance team helps clients across the medical device sector to navigate a wide range of legal and practical issues.

These include:

• Medical and in-vitro medical device compliance and market placement in the UK and EU.
• Changes to the regulatory landscape, including maximising the opportunities offered by transition periods whilst ensuring continued compliance.
• Clearly delineating the legal obligations placed on economic operators in complex supply chains.
• Importing and exporting medical devices.
• Conducting and supporting internal investigations.
• Liaising with (and challenging) regulators including the police, CQC, MHRA and HSE.
• Licensing requirements for pharmacies and the possession and supply of controlled drugs.
• Obtaining and maintaining relevant CQC registrations.
• Representation during inquests.

Under the Medical Devices Regulations 2002, devices must be registered with the Medicines and Healthcare products Regulatory Agency (MHRA) before being placed onto the market. A ‘Responsible Person’ for marketing the device must be appointed under The Medical Device Regulations 2002. 

Similarly, manufacturers placing a device on the GB market must register with the MHRA and pay the applicable fee.

If a manufacturer isn’t established in the UK, it must appoint a ‘UK Responsible Person’ to register and act on its behalf, including registering the manufacturer’s devices with the MHRA. 

To register, companies must pay the relevant fee and provide the MHRA with various information about the device and manufacturer including:

• Legal entity name and address of the manufacturer as it appears on the device labelling or packaging.
• Company type and administrative contact.
• Letter of designation for the UK Responsible person (if applicable).
• Which legislation applies to the device.
• Class, name, model, reference number and attributes of the device (such as sterility and/or ‘contains latex’). 
• UK Approved Body (where applicable).
• Copies of any conformity assessment certificates of self-certification declarations, as applicable.

Depending on which legislation the device has been certified under, medical devices need a CE or UKCA marking, which must appear on the label. To obtain this marking, the product may need to undergo a conformity assessment by an Approved Body or Notified Body, whose number must also appear on the label.

The name and address of the UK Responsible Person (where applicable) must be included on the product labelling, outer packaging or instructions for use in cases where the UKCA marking has been affixed (including when devices have been dual marked). 

Further information to be supplied — including what information must be included in the instructions for use and mandatory labelling information — is set out at paragraph 13 of Annex I of Council Directive 93/42/EEC.

Medical device manufacturers simply need to be registered with the Medicines and Healthcare products Regulatory Agency (MHRA) to place products on the market.

Similarly, importers of devices from third countries don’t require specific authorisation but will become legally responsible for the devices and compliance with the MDR. Medical device distributors don’t require authorisation for wholesale trade.

Medical devices must be registered with the Medicines and Healthcare products Regulatory Agency (MHRA) before being placed on the market. This requires evidence that the device conforms to CE or UKCA marking requirements. 

The MHRA doesn’t conformity assess medical devices. If third-party conformity tests are required (determined by the class of the device), a contractual arrangement with a Notified Body or Approved Body will specify the timeline for the assessment and the associated fees.

CE markings and UKCA markings remain valid if the device continues to meet the legal standards and isn’t significantly altered.

The Manufacturer's On-line Reporting Environment (MORE) is the MHRA's system for device manufacturers, suppliers and authorised representatives to report adverse medical incidents and provide responses to MHRA incident investigations.

Healthcare professionals should report adverse incidents that involve medical devices using the MHRA’s Yellow Card Scheme.