UK Conformity Assessment process not yet published officially, it is likely that UKCA Marking process will be similar to that of new MDR and IVDR regulations covering Clinical evaluation Report and Performance evaluation reports. All manufacturers planning to sell medical devices in the UK market has to develop an in-house team or Identify an external consulting team early for the Conformity Assessment process.
UKCA Mark - An Overview
UKCA Mark Consultants
The role of consultants are
- Guidance on the device classification, Requirements Identification
- Development of Technical documentation
- Biological Evaluation
- Safety Evaluation
- Risk analysis support
- Clinical Evaluation
- Answering UK Certification Bodies and update technical documentation
UKCA Mark Certification Bodies and Certification Timeline
Readers can get more information on UKCA approved bodies from below website.
Contact I3CGlobal for those looking or outsourcing UKCA Technical support service for medical and IVD devices. Contact us to learn more.