EU MEDICAL DEVICE CERTIFICATION AND CE MARKING
COMPLIANCE WITH EUROPEAN REGULATIONS
Effective planning is essential to meet the European requirements that regulate this sector. Every medical device placed on the market must comply with highly specific European regulation requirements to obtain CE marking, which is fundamental for commercializing your product in the European Union and, therefore, also in Italy
This is why you should rely on us: from our in-depth study and with our expertise, we will be able to guide you in the correct procedure to comply with European regulations and obtain the CE marking, ensuring that your product meets the requirements
Find out how we can help you: fill out the form now!
European Commission
EU Regulation 2017/745 MDR
Italian Ministry of Health
Management of regulatory and compliance requirements applicable to the design and development process of medical devices
Assessment and development of procedural aspects for CE marking
Study and identification of the strategies adoptable for obtaining the CE Marking of medical devices
Assessment for the identification of the risk class of the Medical Device according to the applicable Regulations
Evaluation and identification of medical device families for the definition of Basic UDI codes
Support for requesting UDI codes to issuing bodies designated by the European Commission and for their management and use
Drafting of Technical Documentation according to Annexes II and III of EU Regulation 2017/745
Customer assistance during inspection audits for certification and surveillance by Notified Bodies
Support in managing the extension of the transitional period to place legacy devices conforming to Directive 93/42/EEC on the market according to Regulation EU 2023/607
Medical Device Registrations in the Database and Repertory of the Italian Ministry of Health
Medical Device Registrations in the EUDAMED Database
WITH YOU EVEN AFTER ACHIEVING CERTIFICATION
We firmly believe in the continuity of the journey we have undertaken together, which extends beyond the phases of consultation, design, production, and ultimately marketing of the medical product
Our service continues with the post-marketing phase, where we monitor the safety of your device after it is placed on the market. This type of surveillance can help further refine the medical device thanks to feedback from users
Finally, we offer our support during both internal and external technical and inspection audits, which are carried out by Competent Authorities, Certification Bodies and Notified Bodies. This type of check is carried out with variable frequency, but thanks to our assistance you will be able to discover how to best prepare yourself
Would you like more information?
Contact us, our team is at your service.
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