Medical Device Class I – EU MDR Compliance Support

Under the EU Medical Device Regulation (MDR 2017/745), Class I medical devices must meet strict safety, performance, and documentation requirements before they can be placed on the European market. Even though Class I devices are considered low-risk, manufacturers are still required to prepare full technical documentation, conduct conformity assessments, and ensure proper product registration.

Complico provides Class I Medical Device Compliance Services, helping manufacturers and brand owners achieve MDR compliance efficiently — ensuring legal market access across the European Union.

Services Covered

Classification confirmation under EU MDR

MDR conformity assessment guidance

Technical documentation and file preparation

Risk management and clinical evaluation support

EU Declaration of Conformity drafting

UDI assignment and EUDAMED registration support

EU Authorized Representative service (if required)

Post-market surveillance setup guidance

Who Needs This Service

Manufacturers of Class I medical devices

Non-EU medical device brands entering the EU market

Private label medical product sellers

Healthcare product startups

Online and marketplace medical device sellers

Why Choose Complico

✔ MDR expertise for low-risk medical devices
✔ Complete documentation and registration support
✔ Faster route to EU market entry
✔ EU-based compliance partner and Authorized Representative
✔ Reduced regulatory risk

Launch your Class I medical device in Europe with full MDR compliance.

📌 Complico – Your trusted EU medical device compliance partner.