Ensuring compliance with EU MDR (2017/745) and IVDR (2017/746) requires proper product registration before placing medical devices and in vitro diagnostic (IVD) products on the European market. At EUmAccess GmbH, we support manufacturers with the complete EU product registration process, ensuring seamless market entry and regulatory compliance.
Why is Product Registration Important?
Before selling a medical device (MD) or in vitro diagnostic (IVD) device in the European Economic Area (EEA), manufacturers must:
Comply with MDR/IVDR regulations
Register devices with EU Competent Authorities & EUDAMED
Obtain CE Marking & meet conformity assessment requirements
Assign an EU Authorised Representative (if outside the EU)
Our Product Registration Services
EUDAMED Registration Support
- Registering manufacturers, EU Authorised Representatives (E.A.R.), and Importers in EUDAMED
- Assisting with Single Registration Number (SRN) issuance
- Ensuring compliance with UDI & Device Registration requirements
Competent Authority Registration
- Some EU Member States still require national registration before EUDAMED is fully operational
- We facilitate product registration in countries like Italy, Spain, and others requiring national database submissions
CE Marking & Technical Documentation Review
- Assisting with CE Marking certification for medical devices & IVDs
- Ensuring conformity with General Safety & Performance Requirements (GSPR)
- Reviewing Technical Files, Declarations of Conformity (DoC), and Clinical Data
Classification & Regulatory Pathway Guidance
- Determining the correct risk classification of your product (Class I, IIa, IIb, III for MDs & Class A, B, C, D for IVDs)
- Advising on the self-certification process (Class I MD, Class A IVD) and Notified Body involvement
Labeling & UDI Compliance
- Ensuring product labeling, instructions for use (IFU), and packaging meet MDR/IVDR requirements
- Assistance with Unique Device Identification (UDI) assignment & registration
Who Needs EU Product Registration?
Medical Device Manufacturers (EU & non-EU)
IVD Manufacturers
Non-EU Companies Seeking an EU Authorised Representative
Importers & Distributors bringing medical devices into the EU
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.