CE Marking and UKCA consulting

The CE mark is a mandatory mark of conformity. Manufacturers must ensure that their products meet relevant regulatory requirements before

selling medical devices into the European Economic Area (EEA). Relevant EU regulations applying to medical devices:

Medical Device Regulation

In Vitro Diagnostic Regulation

Medical device directives of the EU provide manufacturers with

multiple pathways to compliance

UKCA stands for UK Conformity Assessed Mark. After Brexit, EU regulations do not apply to the UK any more. The UKCA certification mark is required for medical devices and IVD devices entering the UK market (excluding Northern Ireland).

Our Services:

Application strategy consulting

Determine product classification

Choose reasonable conformity pathway

Select approprate notified body(UK Authorized Agency)

Testing service comply with harmonized standards

Complete clinical evaluation

Prepare CE / UKCA technical documents

EU authorized representative service