EU CE marking
Our CE marking services
Meliora Compliance will help you to obtain CE mark for your device in compliance with the Medical Device Regulation (MDR 2017/745). This applies to the transfer of your legacy CE devices, as well as to newly designed products.
We offer to perform the following tasks:
- Help to create your CE regulatory plan
- Select a notified body (NB) and act as your main contact for your NB
- Select and appoint your person responsible for regulatory compliance (PRRC) as appropriate according to Article 15 of the Regulation, or act as your PRRC in case you are a micro or a small enterprise
- Determine the class of your device according to Article 51 of EU MDR
- Support your risk management activities in compliance with ISO 14971
- Help to create a Clinical Evaluation Report (CER) according to MEDDEV 2.7/1 and your overall clinical strategy for CE marking
- Implement or improve your Quality Management System, preferably in compliance with ISO 13485
- Host your notified/certification body audits
- Work with your design and development team to make sure that development activities, including design verification and validation testing, are performed according to the EU harmonized standards and other applicable requirements
- To provide regulatory support to your clinical investigations which will serve to gather clinical evidence for CE marking
- Plan post-market surveillance (PMS) activities
- Review existing, or build new CE Marking technical documentation according to the Annex II of EU MDR
- Review IFU, labels and marketing materials to ensure compliance with regulatory requirements
- Submit the technical documentation to your notified body on your behalf, and defend it until successful CE marking
- Work with your economic operators to make them compliant, including the selection and appointment of you European Authorized Representative to act on your behalf if you are not based in EU
- Support you in the post-market surveillance activities (ISO and EU MDR surveillance audits by your certification/notified body, QMS maintenance, technical documentation maintenance, change notifications to your NB, PMS report, vigilance, PSUR, SSCP, PMCF, etc.)
ENGLISH 
CZECH