Brexit: Understanding the New Requirements for Medical Device

After months of negotiations, the United Kingdom (UK) and the European Union (EU) finally reached an agreement that will define their future relationship, which came into effect at 23:00 GMT on December 31, 2020. As of this date, the UK is a “third country” from the EU perspective, and the same applies to the European Economic Area (EEA) from the UK perspective.
This context has been one of great change for all businesses, in which medical devices have not been the exception. From that date, for medical devices to move between UK and EEA markets, new requirements must be met. But this not only affects England, it also affects Northern Ireland in a special way, where its situation also becomes “special”

The following situations are the most common for Medical Device Manufacturers:

1. Medical Device Manufacturer in UK wants to sell in EEA
2. Medical Device Manufacturer in EU wants to sell in UK
3. UK-based Medical Device manufacturers placing devices on the Great Britain market
4. Mutual recognition agreements with the United Kingdom for medical devices
5. Mutual recognition agreements with the United Kingdom for medical devices
6. What about Notified Bodies?

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RQMIS Brexit White Paper

Great Britain registration process

For the MHRA to carry out its market surveillance activities, it is necessary for economic operators (Medical Device Manufacturer or UKRP- UK Responsible Person) to register themselves, their products, applicable certificates and clinical investigations or performance studies. The medical device registration requirements apply to all devices marketed in the UK, whether newly manufactured or refurbished, this includes custom made devices and systems or procedure packages that contain at least one device and include IVDs for device evaluation performance.

UK based medical device manufacturers can complete the registration themselves, but manufacturers outside of the UK must have a designated UK Responsible Person (UK Authorized representative) based in the UK to register for them. The UKRP must register the manufacturer, importer, and their devices.

Furthermore, medical device manufacturers based UK and Northern Ireland based authorized representatives are required to keep their current records of Class I devices, custom made devices and general IVDs. This implies that any new device must be registered before it can be marketed.

For non-UK manufacturers that were already supplying its devices to the UK market, the following deadlines for registration apply:

• Active implantable devices, Class III devices, Class IIb implantable devices, and IVDs listed on List A must be registered before May 1, 2021;
• Class IIb non-implantable devices, Class IIa devices, IVDs listed on List B, and self-test IVDs must be registered before September 1, 2021;
• All other devices (Class I devices and general IVDs) must be registered before January 1, 2022.
  

These are also deadlines for registration of the medical device manufacturer and its UK authorized representative. Deadlines are not specified for importers, but they must register as soon as possible, as importers must register before placing their devices on the market in the UK.

However, MDR 2017/745 and IVDR 2017/745 will be fully implemented in EU Member States from May 21, 2021 and May 21, 2022 respectively. As these regulations did not come into force during the transition period, their provisions will NOT be automatically implemented and enforced in Great Britain. The UK MDR 2002, on the other hand, will continue to have effect in Great Britain after the transition period.

When conformity assessment by a third party is required, it is necessary to apply to a UK Approved Notified Body. The MHRA designates the UK Approved Notified Bodies, so that the ability to conduct conformity assessments regarding the requirements for UKCA marking.

Compliance requirements

In Great Britain, devices must comply with UK MDR 2002 (implementing the EU AIMDD, MDD and IVDD Directives), MDR 2017/745 (until 30 June 2023), or IVDR 2017/745 (until 30 June 2023) to be registered with the MHRA. Manufacturers must therefore comply with the product marking and conformity assessment requirements of these directives.

Labelling of medical devices after Brexit

During the transition period, both medical devices and in vitro diagnostic devices can be traded freely between the UK and the EU. As of 1 January 2021, the rules for importing such products from third countries will apply to the UK. Just one rule concerns conformity with European regulations; to demonstrate conformity, manufacturers will have to obtain a CE certificate from a recognized notified body in one of the 27 remaining EU member states. After 1 January 2021 the product label must state the identification number of the new notified body.