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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 |