CE Marking Consultancy for Medical Devices – Regulation (EU) 2017/745 (MDR)
At EUmAccess GmbH, we provide expert CE Marking consultancy services to help medical device manufacturers comply with Regulation (EU) 2017/745 (MDR) and achieve seamless market access in the European Union (EU).
What is CE Marking for Medical Devices?
CE Marking is a mandatory certification that confirms a medical device meets EU safety, performance, and regulatory requirements under MDR (EU 2017/745). It allows free movement of medical devices within the European Economic Area (EEA) and is a prerequisite for selling devices in the EU.
Confirms compliance with MDR 2017/745
Required for all medical devices (Class I, IIa, IIb, III)
Demonstrates product safety, quality, and regulatory conformity
Mandatory for market entry in the EU
Our CE Marking Consultancy Services
Medical Device Classification & Regulatory Strategy
- Identifying the correct MDR classification (Class I, IIa, IIb, III)
- Determining the appropriate conformity assessment route
Technical Documentation Preparation & Review
- Ensuring compliance with Annex II & III of MDR
- Preparing Device Technical File & Design Dossier
- Assisting with clinical evaluation reports (CER)
EU Authorized Representative (E.A.R.) Services
- Acting as your official EU Representative for regulatory compliance
- Managing EUDAMED registration & post-market surveillance (PMS)
Notified Body Interaction & Certification Support
- Assisting in selecting a Notified Body (for Class IIa, IIb, III devices)
- Supporting the conformity assessment & audit process
Risk Management & Post-Market Surveillance (PMS)
- Implementing ISO 14971:2019 risk management requirements
- Developing Post-Market Surveillance (PMS) & Vigilance plans
CE Marking Training & Compliance Consulting
- Providing expert training & workshops on MDR requirements
CE Marking Process Under MDR 2017/745
Device Classification
- Determine risk class (Class I, IIa, IIb, III)
Conformity Assessment
- Choose the appropriate certification pathway
Technical Documentation & Clinical Evaluation
- Prepare required documents & testing reports
Notified Body Certification (If Required)
- Submit for audit & approval
EUDAMED Registration
- Register the manufacturer, device, and UDI in EUDAMED
Declaration of Conformity (DoC) & CE Marking
- Issue the DoC and affix the CE Mark
Post-Market Surveillance (PMS) & Vigilance
- Ensure ongoing compliance & reporting
Who Needs CE Marking Under MDR?
- Medical Device Manufacturers (EU & Non-EU)
- Non-EU Manufacturers (Must appoint an EU Authorized Representative)
- Distributors & Importers (Must verify device compliance)
Drop here a note
contact@eumaccess.com
Call us Directly
+49 621-76-44-10-101
Drop here a note
contact@eumaccess.com
Call us Directly
+49 621-76-44-10-101
EUmAccess GmbH
At EUmAccess GmbH, we specialize in providing expert regulatory and compliance solutions to businesses with a focus on the Medical Devices (MD) and In Vitro Diagnostic (IVD) sectors, we assist manufacturers in navigating the complex regulatory landscape, ensuring smooth market entry and compliance with EU directives and regulations.