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?
Following Brexit, the Medicines and Healthcare Products Regulatory Agency (MHRA) implemented a conformance evaluation process known as the UKCA marking. It acts as a mark to verify that IVDs and medical devices adhere to UK regulatory criteria. Manufacturers who want to enter or keep access to the UK market must have this accreditation.
What are the Requirements for UKCA Marking?
Important Requirements for UKCA Marking In order to receive UKCA marking, medical devices and IVDs must meet the following requirements:
- Adherence to previous EU directives, including the In Vitro Diagnostic Directive (IVDD), the Active Implantable Medical Device Directive (AIMDD), and the Medical Device Directive (MDD).
- Technical documentation has been modified to comply with UK requirements.
- For non-UK manufacturers, the EU Authorized Representative is replaced by a UK Responsible Person (UKRP).
- Citation of pertinent UK law as opposed to EU law.
What are the Changes to UKCA Marking Requirements?
- In order to better conform to the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), the MHRA is revising its regulatory framework. The following changes will go into effect in July 2025: Designating a Quality Person to oversee regulations.
- Manufacturers are subject to increased liability insurance obligations.
- risk-based reclassification of specific devices.
- more stringent regulatory oversight and compliance audits.
What is the Deadline for UKCA Marking?
The present CE marking status of IVDs or medical devices determines when mandatory UKCA labeling will occur.
- MDR/IVDR/IVDD CE Marked Devices: UKCA marking is required by the end of the CE certificate or by June 30, 2030, whichever comes first.
- Devices with MDD/AIMDD CE markings must be UKCA marked by June 30, 2028, or when the certificate expires, whichever occurs first.
The UKCA mark will be necessary for ongoing market access after these deadlines.
What are the Registration Requirements for UKCA Marking?
In order to comply with UKCA, manufacturers need to:
- A UK Responsible Person (UKRP) should be appointed. Manufacturers located outside of the UK are required to appoint a UKRP to manage regulatory duties.
- Device registration with MHRA: The MHRA requires that all IVDs and medical devices be registered. Please take note that on January 1, 2022, the transition period for designating a UKRP and device registration came to an end.
How do Operon Strategist Experts Help with the UKCA Marking Process?
It might be difficult to obtain UKCA marking and stay in conformity with changing UK rules. With end-to-end assistance, regulatory consultants like Operon Strategist streamline this procedure and guarantee a seamless transition and a successful market debut.
Operon Strategist provides:
- Professional Advice: thorough familiarity with MHRA rules and UKCA marking standards.
- Help with Technical Documentation: Creating thorough and legal technical files.
- Conformity Assessments: Using in-depth analyses to guarantee compliance.
- Helping with device registration and UKRP appointments is known as MHRA Registration Support.
- Regulatory Updates: Maintaining compliance by staying abreast of the UK’s changing regulatory environment.
Get in touch with us now!
Allow us to assist your medical device company in becoming compliant with UKCA markings and effectively entering the UK market. To find out more about our UKCA Marking Consultancy Services, Contact us today!