CE Medical Devices – EU MDR Compliance & Market Access

Entering the European medical device market requires strict compliance with the EU Medical Device Regulation (MDR 2017/745). Manufacturers must demonstrate product safety, performance, and regulatory conformity before applying the CE mark. Non-compliance can lead to product bans, recalls, and loss of market access.

Complico provides end-to-end CE certification and MDR compliance support, helping medical device manufacturers navigate complex regulatory requirements and achieve smooth, successful entry into the EU market.

Services Covered

MDR regulatory gap assessment

Device classification support (Class I, IIa, IIb, III)

Technical documentation & clinical evaluation guidance

Risk management and safety file preparation

Labeling and IFU compliance review

Notified Body coordination support

CE marking implementation assistance

EU Authorized Representative (EU-REP) services

Post-market surveillance (PMS) setup support

Who Needs This Service

Medical device manufacturers outside the EU

EU-based manufacturers seeking MDR compliance

Startups launching new medical technologies

Importers and distributors of medical devices

Amazon and online marketplace sellers of medical products

Why Choose Complico

✔ Practical MDR expertise for smooth certification
✔ Complete documentation and compliance support
✔ Reduced risk of certification delays or rejection
✔ EU-based regulatory presence through EU-REP services
✔ One-stop solution for medical device market entry

Bring your medical devices to the European market with full MDR compliance and confidence.

📌 Complico – Your trusted partner for CE medical device certification in Europe.