Medical Device Class IIb – EU MDR Compliance Support

Medical devices classified as Class IIb under the EU Medical Device Regulation (MDR 2017/745) are considered higher-risk devices that sustain or support life, are used long-term, or deliver critical therapeutic functions. Because of their risk profile, Class IIb devices are subject to extensive conformity assessment by an EU Notified Body, detailed clinical evaluation, and strict post-market monitoring requirements before they can be placed on the European market.

Complico provides Class IIb Medical Device Compliance Services, guiding manufacturers through complex MDR approval procedures, technical documentation development, clinical evidence preparation, and Notified Body engagement — ensuring successful and timely EU market access.

Services Covered

MDR device classification confirmation

Regulatory roadmap and approval strategy

Full technical documentation (Annex II & III) preparation

Risk management and usability engineering files

Clinical evaluation and performance evidence support

Notified Body selection and coordination

EU Declaration of Conformity drafting

UDI assignment and EUDAMED registration

EU Authorized Representative service

Post-market surveillance and vigilance system setup

Who Needs This Service

Manufacturers of Class IIb medical devices

Non-EU medical device brands entering the EU market

OEM and private-label medical device producers

Advanced therapeutic and surgical device companies

EU marketplace and distributor suppliers

Why Choose Complico

✔ Expert MDR compliance and documentation support
✔ Direct coordination with EU Notified Bodies
✔ Clinical evaluation and risk management expertise
✔ EU-based Authorized Representative available
✔ End-to-end support from concept to EU market launch

Launch your Class IIb medical device in Europe with confidence and full MDR compliance.

📌 Complico – Your trusted EU medical device compliance partner.