The departure of the United Kingdom from the European Union (Brexit) has created a new regulatory landscape for medical devices, impacting UK-based distributors who wish to place devices on either the EU or the UK market. Understanding these changes and the diverging requirements is crucial for ensuring compliance and maintaining market access. This article outlines the key impacts of Brexit on MDR compliance for UK distributors, addressing both routes to market.
Placing Medical Devices on the EU Market Post-Brexit
For UK-based distributors looking to place medical devices on the EU market after the end of the transition period, the following key changes apply:
- No Longer Considered EU Economic Operators: As of January 1, 2021, UK-based distributors are considered “third country” economic operators in the eyes of the EU MDR.
- Need for an EU-Based Authorised Representative (AR): UK manufacturers (whose devices UK distributors might handle) now require an EU-based Authorised Representative to place devices on the EU market. While this is primarily a manufacturer obligation, distributors need to ensure their supplying manufacturers have appointed one. The AR acts as the legal representative in the EU and is responsible for certain tasks related to the device’s compliance.
- Importer Obligations: When a UK-based distributor imports devices from the UK into the EU to make them available, the distributor assumes the obligations of an importer under Article 13 of the MDR. These obligations include verifying that the device bears the CE marking, has the EU Declaration of Conformity, is properly labelled and accompanied by instructions for use in the required languages, and that the importer’s details are on the device or its packaging.
- CE Marking Still Required for EU Market: Devices intended for the EU market must continue to bear the CE marking, demonstrating conformity with the EU MDR. UK-based Notified Bodies are no longer recognised for issuing CE certificates for the EU market. Therefore, manufacturers (including those in the UK supplying UK distributors for EU distribution) must use an EU-recognised Notified Body for conformity assessment where required.
- Registration in EUDAMED: While distributors established within the EU are not required to register as actors in EUDAMED, UK-based distributors acting as importers into the EU will likely need to understand the registration requirements for devices and manufacturers within the database.
- Vigilance and Post-Market Surveillance (PMS): UK-based distributors placing devices on the EU market are still obligated under Article 14 of the MDR to forward any complaints or reports of incidents they receive to the manufacturer, the EU Authorised Representative, and the importer (if they are not the importer themselves). They must also cooperate with competent authorities in any market surveillance activities.
Placing Medical Devices on the UK Market Post-Brexit
The regulatory landscape for placing medical devices on the UK market has also changed significantly for UK-based distributors:
- MHRA as the Sole Regulatory Authority: The Medicines and Healthcare products Regulatory Agency (MHRA) is now the sole regulatory authority for medical devices in Great Britain (England, Scotland, and Wales). Northern Ireland follows EU MDR regulations under the Northern Ireland Protocol.
- UKCA Marking: The UK has introduced the UK Conformity Assessed (UKCA) marking, which will eventually replace the CE marking for devices placed on the Great Britain market. However, there are transitional arrangements in place. Currently, CE-marked devices are accepted in Great Britain until June 30, 2028, for devices compliant with MDD or AIMDD, and until June 30, 2030, for devices compliant with MDR or IVDR (or until the certificate expires, whichever is sooner). After these dates, the UKCA mark will be required.
- UK Responsible Person (UKRP): Manufacturers based outside the UK (including those in the EU) wishing to place devices on the Great Britain market must appoint a single UK Responsible Person (UKRP) established in the UK. This UKRP is responsible for various tasks, including registering devices with the MHRA. UK-based distributors need to ensure that non-UK manufacturers they source from have appointed a UKRP.
- Registration with the MHRA: All medical devices placed on the UK market must be registered with the MHRA. The timelines for registration depend on the device’s risk class. UK-based distributors might need to understand the registration status of the devices they distribute.
- Continued Application of Existing EU Directives (as amended): The UK Medical Devices Regulations 2002 (as amended) continue to be the primary legislation in Great Britain, referencing the older EU Directives (MDD, AIMDD, IVDD) for the time being. However, the UK is developing its own future regulatory framework for medical devices, which may diverge further from the EU MDR over time.
- No Specific Distributor Obligations in UK Regulations (yet): While the current UK regulations don’t explicitly outline distributor obligations in the same detail as Article 14 of the EU MDR, it is an offence to supply a device that does not meet the UK’s requirements. Therefore, UK distributors must ensure the devices they handle are compliant with the applicable UK regulations and that non-UK manufacturers have met their obligations (e.g., appointing a UKRP).
- Northern Ireland Protocol: It’s crucial to remember that Northern Ireland continues to align with EU MDR and IVDR. Devices placed on the Northern Ireland market require CE marking and may also require a UKNI marking if a UK Notified Body was involved in the conformity assessment. Goods bearing the “CE & UKNI” marking are not accepted on the EU market.
Practical Steps for UK-Based Distributors
To navigate this complex landscape, UK-based distributors should take the following steps:
- Understand the Intended Market: Clearly define whether the devices are intended for the EU market, the UK market (Great Britain and/or Northern Ireland), or both.
- Map Your Supply Chain: Identify the location of your manufacturers and understand their post-Brexit regulatory strategies for each intended market.
- EU Market Compliance:
- Ensure non-EU manufacturers (including UK-based) have appointed an EU Authorised Representative.
- If you are importing into the EU, understand and fulfil your obligations as an importer under Article 13 of the MDR.
- Verify that devices for the EU market have valid CE marking from an EU-recognised Notified Body (if required).
- Stay informed about EUDAMED requirements.
- Maintain robust vigilance and PMS procedures for the EU market.
- UK Market Compliance:
- Ensure non-UK manufacturers have appointed a UK Responsible Person.
- Understand the timelines for the acceptance of CE marking and the eventual requirement for UKCA marking.
- Monitor updates from the MHRA regarding registration requirements and the future UK regulatory framework.
- While not explicitly detailed yet, ensure you are not supplying non-compliant devices in the UK market.
- Labelling Requirements: Be aware of specific labelling requirements for both the EU and UK markets, including the need for importer details on EU-bound products and the potential need for UKRP details on UKCA-marked products.
- Stay Informed: Continuously monitor regulatory updates from the EU Commission and the MHRA, as the post-Brexit landscape is still evolving.
Conclusion
Brexit has introduced significant complexities for UK-based distributors of medical devices. Navigating the requirements for both the EU and UK markets demands a thorough understanding of the new regulations, proactive communication with manufacturers, and adaptation of internal processes. By taking the necessary steps to ensure compliance with both EU MDR and the evolving UK regulations, UK distributors can maintain access to these important markets and continue to play a vital role in the medical device supply chain.