Question 1

What is MHRA and why is it important for medical device manufacturers?

Accepted Answer

The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK's regulatory authority responsible for medical device safety and compliance following Brexit. The MHRA enforces the UK Medical Devices Regulations 2002 (as amended) and oversees the transition from CE marking to UKCA marking for Great Britain (England, Wales, Scotland). Northern Ireland follows a different regime under the Northern Ireland Protocol. All medical devices placed on the UK market must comply with MHRA requirements and manufacturers must register with the MHRA.

Question 2

What is UKCA marking and when is it required?

Accepted Answer

UKCA (UK Conformity Assessed) marking is the UK's product marking for medical devices placed on the Great Britain market (England, Wales, Scotland). Timeline: CE marking remains accepted until July 1, 2026 (extended deadline), UKCA marking becomes mandatory after July 1, 2026 for new devices, Requirements: Conformity assessment by UK Approved Body (for Class IIa, IIb, III devices), registration with MHRA, UK Responsible Person (UKRP) designation for non-UK manufacturers. Note: Northern Ireland follows EU rules (CE marking) under the Northern Ireland Protocol.

Question 3

What is a UK Responsible Person (UKRP) and who needs one?

Accepted Answer

A UK Responsible Person (UKRP) is a natural or legal person established in the UK designated by a non-UK manufacturer to act on their behalf with the MHRA. Requirements: Must be based in the UK (Great Britain), register with MHRA as UKRP, Responsibilities: Register devices with MHRA, maintain technical documentation and declarations of conformity, cooperate with MHRA on safety and performance, inform MHRA of incidents and field safety corrective actions, terminate availability if device non-compliant. A UKRP is mandatory for all non-UK manufacturers (including EU manufacturers) placing devices on the Great Britain market.

Question 4

What are UK Approved Bodies and how do they differ from EU Notified Bodies?

Accepted Answer

UK Approved Bodies are organizations designated by the MHRA to perform conformity assessments for medical devices in Great Britain, functioning similarly to EU Notified Bodies. Key Differences Post-Brexit: UK Approved Bodies issue certificates for UKCA marking (valid in GB only), EU Notified Bodies issue certificates for CE marking (valid in EU/EEA), separate certificates needed for UK and EU markets unless transitional arrangements apply. For Northern Ireland: EU Notified Bodies can assess devices under the NI Protocol. Manufacturers with both UK and EU markets may need dual certifications or strategic Approved/Notified Body selection.

Question 5

How does the Northern Ireland Protocol affect medical device regulations?

Accepted Answer

The Northern Ireland Protocol creates a dual regulatory system in the UK: Great Britain (England, Wales, Scotland): UK Medical Devices Regulations 2002 (as amended), UKCA marking (mandatory from July 1, 2026), UK Approved Bodies, MHRA oversight. Northern Ireland: EU MDR/IVDR continue to apply, CE marking required, EU Notified Bodies, MHRA and EC joint oversight. Practical Implications: Devices placed on NI market can access GB market, devices for GB market cannot automatically access NI market without CE marking, manufacturers may need dual compliance strategies.

Question 6

What are the UK Medical Devices Regulations 2002 (as amended)?

Accepted Answer

The UK Medical Devices Regulations 2002 (MDR 2002), as amended post-Brexit, establish the legal framework for medical devices in Great Britain. Key requirements include: Classification: Class I, IIa, IIb, III based on risk, Conformity Assessment: Self-declaration (Class I) or UK Approved Body involvement (higher classes), Essential Requirements: Safety and performance standards aligned with international norms, UKCA Marking: Required from July 1, 2026, Registration: MHRA device and manufacturer registration, Post-Market Surveillance: Vigilance reporting and field safety corrective actions. The MHRA regularly publishes guidance documents and consults on further amendments.

Question 7

How often is MHRA regulatory news updated and how can I stay informed?

Accepted Answer

MHRA regularly publishes guidance documents, regulatory updates, safety alerts, and policy consultations related to medical devices and the post-Brexit transition. Our platform aggregates daily updates from 7 premium commercial sources including RAPS, Emergo by UL, Citeline, and Pacific Bridge Medical. We recommend checking this page regularly and subscribing to MHRA email alerts for critical safety information and regulatory changes, especially regarding UKCA marking transition deadlines.

Question 8

What commercial sources does this platform use for UK MHRA news?

Accepted Answer

We aggregate UK regulatory intelligence from 7 premium sources: RAPS (Regulatory Affairs Professionals Society), Emergo by UL, Citeline MedTech Insight, Pacific Bridge Medical, Asia Actual, Pure Global's proprietary research, and Qualtechs. These sources provide expert analysis, real-time updates, and strategic insights beyond basic MHRA announcements, helping you navigate post-Brexit transitions, UKCA marking, UKRP designation, and dual UK-EU compliance strategies.

UK MHRA Medical Device News 2025: UKCA Marking & Post-Brexit Regulatory Updates | Pure Global

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