UK Medical Device Registration Services

Media‑device manufacturers looking for UK market‑entry face a regulatory framework that demands precision, clarity and reliable support. DDReg delivers full‑spectrum Medical Device Regulatory Services in UK, specialising in MHRA Medical Device Registration, IVD device registration, UK classification consulting and lifecycle‑management. With deep knowledge of the UK regulatory landscape, we guide you to register medical devices in UK with confidence.

The UK medical device market continues to offer substantial opportunities, driven by high demand for innovative technologies across healthcare settings. Post-Brexit, the regulatory environment has shifted significantly. Manufacturers must now comply with the Medicines and Healthcare products Regulatory Agency (MHRA) framework, implement UKCA (UK Conformity Assessed) marking for devices sold in Great Britain, and appoint a UK Responsible Person (UKRP) if they are based outside the UK. These changes have increased the complexity of market entry, but they also create clear pathways for companies that partner with experienced regulatory consultants.

• + Regulatory Authority
  • MHRA oversees all medical devices placed on the market in Great Britain (GB).
  • Northern Ireland (NI) must follow EU MDR 2017/745 and IVDR 2017/746.
• + Applicable Legislation
  • UK MDR 2002 (as amended) governs device safety, registration, and compliance.
  • Full compliance required with new UK regulations effective 1 July 2025.
• + Key Requirements
  • Authorized Representative: UK Responsible Person (UKRP) for non-UK manufacturers.
  • Quality Management System: ISO 13485:2016.
  • Assessment of Technical Data: Conducted by UK Approved Bodies for UKCA marking.
  • Valid Markings:
    • GB – UKCA or CE
    • NI – CE or CE + UKNI
  • Submission Format: Online via MHRA Device Online Registration System (DORS).

Device classification is the first step in obtaining MHRA registration and launching your device in the UK.

Classification of IVDs uses separate rules. High‑risk IVDs (e.g., Annex II List A) require stricter conformity assessment.

• + Regulatory Strategy & Pathway Assessment
  • Evaluation of device type, risk class, and intended use.
  • Determination of applicable conformity assessment route (UKCA or CE).
  • Guidance on Quality Management System (QMS) requirements such as ISO 13485.
• + Device Classification Consulting
  • Assistance with classification under UK MDR 2002 (as amended).
  • Mapping to MHRA-defined risk categories for both general medical devices and IVDs.
• + MHRA Registration Services
  • Preparation and submission via MHRA’s DORS system.
  • Handling of GMDN codes, manufacturer details, UDI information, declarations.
  • Liaison with MHRA for queries and updates.
• + UK Responsible Person (UKRP) Support
  • Acting as or helping appoint an authorised UKRP.
  • Drafting designation letters and maintaining compliance docs.
  • Communication with MHRA on behalf of the manufacturer.
• + MHRA IVD Device Registration
  • Full support for IVD performance evaluation & classification.
  • Preparation of technical docs under post-July 2025 rules.
• + Conformity Assessment & UKCA Marking Assistance
  • Coordination with UK Approved Bodies for audits.
  • Review of documentation, risk management, product labelling.
  • Guidance on CE → UKCA transition.
• + Post-Market Surveillance & Vigilance Support
  • Monitoring device performance and MHRA incident reporting.
  • Management of FSCAs.
  • Periodic safety updates and renewal submissions.
• + Regulatory Intelligence & Lifecycle Management
  • Tracking of MHRA regulatory updates.
  • Support for amendments, renewals, portfolio management.
  • Strategic advice for commercial alignment.