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CE Marking for Medical Devices

CE marking is not a quality mark, but a declaration that your medical device meets the essential safety and performance requirements outlined in the EU Medical Device Regulation (MDR 2017/745). Compliance with the MDR ensures that your product is safe, effective, and suitable for its intended purpose within the European market. obligations, often with mandatory assessment by a Notified Body.

 
 
 
 

Obtain MDR certification

Start by finding out what you need for the CE marking of your medical device. Medunion provides expert assessments of your situation through interactive workshops and transparent flat-rate pricing. Then choose the hands-on support that fits you best: we tailor our team to your individual needs. If you believe we could support you in any way, get in touch with us. clinical evidence, and post‑market surveillance obligations, often with mandatory assessment by a Notified Body.

 
 
 
 
Detail shot of an ultrasound scanner probe in a medical facility setting.

Our MDR Compliance Services

Medunion provides tailored support to ensure your Medical devices meet the requirements of the EU Medical Device Regulation (IVDR 2017/745). Our MDR-specific services include:

MDR Classification

Identify the correct risk classification of your device (Class I, IIa, IIb, or III). This impacts the conformity assessment procedure.

Testing Standards & Guidance Identification

Support in defining applicable standards, MDR requirements, and relevant MDCG guidance.

Clinical Evaluation

Create a Clinical Evaluation Report (CER) in accordance with MEDDEV 2.7/1 Rev. 4 and MDR Annex XIV.

Technical Documentation

Prepare comprehensive technical documentation demonstrating your device’s conformity with applicable requirements.

EU Authorised Representative

Acting as your EU REP to ensure compliance and communication with Competent Authorities.

Post-Market Surveillance & Vigilance

Setup and improvement of PMS and vigilance systems in compliance with MDR obligations.

QMS Implementation (ISO 13485)

Alignment of your quality system with ISO 13485:2016, including audit preparation and hands-on support.

FAQ

Any product with a medical purpose such as diagnosis, prevention, monitoring, treatment, or alleviation of disease is likely regulated as a medical device or accessory and must be assessed under MDR classification rules.

Risk class (I, IIa, IIb, III) is based on intended purpose, duration of use, invasiveness, and whether the device is active, with specific classification rules defined in Annex VIII of MDR; we perform a structured classification review as a first step.

MDR introduces stricter classification, more detailed clinical evidence requirements, stronger post‑market surveillance, UDI and EUDAMED obligations, and more oversight of economic operators than the previous MDD.

Most devices above Class I (and some Class I devices depending on characteristics) require conformity assessment by an MDR‑designated Notified Body before CE marking.

Manufacturers must maintain comprehensive technical documentation covering device description, design and manufacturing, risk management, clinical evaluation, labeling, usability, and post‑market surveillance planning.

A CER is a systematic assessment of clinical data to demonstrate safety and performance for the intended purpose, and MDR significantly tightens expectations on data quality, equivalence, and ongoing updates.

You must proactively collect and analyze post‑market data, prepare PMS reports or PSURs (depending on class), trend incidents, and feed findings back into risk management and clinical evaluation.

MDR requires manufacturers to appoint at least one qualified individual responsible for ensuring device conformity, technical documentation, PMS, and reporting obligations are fulfilled. is essential.

Streamlined Compliance for the European Market

Reliable Representation for EU Regulatory Affairs

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