Streamlining Your CE Marking Process: Tips for Efficiency and Success
Introduction The CE marking is a mandatory conformity marking for products sold in the European Economic Area, demonstrating compliance with applicable EU directives and regulations. It ensures that medical devices meet essential safety, performance, and quality requirements for market entry in the EU. What...
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After separating itself from the European Union, Great Britain introduced UKCA Mark mandatory for medical devices to conform to the new regulations. Any manufacturer who wishes to enter into the UK market...
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Any manufacturer who intends to market their medical devices, including in-vitro diagnostics in the UK, must register medical devices with the Medicines and Healthcare Products Regulatory Agency (MHRA) before placing them into...
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European Union Medical Device RegulationIntroduction European Union Medical Devices Regulation (EU MDR)Reasons for replacing Medical Device Directives (MDD)Medical Device ClassificationScope of EU MDRChallenges in implementing the MDREU MDR ComplianceReference Introduction European Union...