Product Certification: CE Marking
The European Union (EU) mandates medical device manufacturers to obtain CE marking after meeting the stipulated regulatory requirements around patient safety, product quality and performance. This certification verifies that a device meets all regulatory requirements of the medical devices directive (MDD), In vitro diagnostic device directive (IVDD) or active implantable medical device directive (AIMD) as they apply to your product.
When the manufacturer has signed the declaration of conformity, the device can be CE marked. The CE mark must be affixed visibly, legibly and indelibly on, for example, the instructions for use and symbolises that the product meets the requirements of the legislation.
The CE mark must also be affixed to the sales packaging and the device itself. In the case of a sterile device, the CE mark is placed on the package that keeps the device sterile. In the case of devices involving a notified body, the CE mark must be followed by an identification number of the notified body having assisted in the assessment of the product.
The model for CE marking appears from Annex V of the medical devices regulation.
With over 15+ years experience, our MedTech team has helped several pharma and medical device companies to obtain CE Marking for different classes of medical devices with the following capabilities:
How We Can Help
At Techsol, our expert team of MedTech professionals are specialists in completing a comprehensive MDD-MDR Gap Analysis and then performing product certification of medical devices. We provide specialized services to manufacturers, importers, distributors and healthcare institutions in regard to the accurate and complete implementation of the Medical Devices Regulation (‘MDR’).
We execute the below process to obtain CE Marking for different classes of medical devices.