UKCA Mark Medical Device Consultant
UKCA stands for the United Kingdom Conformity Assessment. It is a requirement for medical devices and IVDs to comply with UK regulations and gain access to the Great Britain market (England, Wales, and Scotland).
What is UKCA marking for medical devices?
UKCA marking is a conformity assessment procedure introduced by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom after Brexit. It is a marking placed on medical devices and In Vitro Diagnostics (IVDs) to demonstrate compliance with UK regulations and ensure access to the UK market.
What are the Requirements for UKCA Marking?
To meet UKCA marking requirements, medical devices and IVDs must comply with the previous EU Directives such as the Medical Device Directive (MDD), Active Implantable Medical Device Directive (AIMDD), and In Vitro Diagnostic Directive (IVDD). Compliance with the technical documentation of these directives generally meets the UKCA marking requirements. However, some modifications are necessary, such as appointing a UK Responsible Person instead of an EU Authorized Representative and referring to UK legislation.
What are the Changes to UKCA Marking Requirements?
The MHRA is updating its regulations to align with the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The proposed revisions, expected to come into effect from July 2025, include the appointment of a Quality Person, liability insurance requirements, up-classification of certain devices, and increased scrutiny overall.
What is the Deadline for UKCA Marking?
The deadline for UKCA marking depends on the type of CE marking held by the medical device or IVD. For MDR/IVDR/IVDD CE Marked Devices, the CE certificate expires or 30 June 2030, whichever is sooner. For MDD/AIMDD CE Marked Devices, the certificate expires or 30 June 2028, whichever is sooner. After these dates, UKCA marking becomes mandatory for continued market access.
What are the Registration Requirements for UKCA Marking?
Companies must appoint a UK Responsible Person (for non-UK manufacturers) and register their devices with the MHRA. The transition period for appointing a UK Responsible Person and registration ended on 1 January 2022.
How do Operon Strategist Experts Help with the UKCA Marking Process?
Navigating the UKCA marking process and ensuring compliance with UK regulations can be complex. Seeking the assistance of regulatory experts or consultants experienced in UK medical device regulations can help facilitate a smooth transition and successful registration of medical devices and IVDs in the UK market.
Operon Strategist specializes in providing expert consulting services for UKCA marking compliance for medical devices and IVDs. Our experienced team of regulatory experts can guide you through the intricacies of UKCA marking requirements, assist with technical documentation, conformity assessments, registration with the MHRA, and ensure compliance with the evolving regulations. Trust us to help you successfully navigate the UK market and meet the necessary safety and performance standards.
Contact us today to learn more about our UKCA Marking Consultancy services and how we can support your medical device business in achieving UKCA compliance.