Regulatory Support for
Medical Devices in Europe
End-to-end CE marking and EU MDR/IVDR compliance expertise for medical device manufacturers seeking European market access — from classification through Notified Body approval.
⚕️ EU Regulatory Frameworks
Medical Device Regulation — Mandatory from May 26, 2021
In Vitro Diagnostic Regulation — Mandatory from May 26, 2022
Required to Sell in Any European Community Country
EU Database for Medical Devices Compliance
CE Marking — European Medical Device Registration
Any company intending to sell a medical device in any European Community country must comply with the relevant Regulation and affix the CE symbol to their product.
✅ EU IVDR
✅ CE Marking
✅ EUDAMED
⚠️ Key Requirement: As of May 26, 2021, compliance with EU MDR 2017/745 is mandatory, replacing the former Medical Device Directive and Active Implantable Medical Device Directive, which are no longer valid for CE marking.
European Medical Device Regulation
The European Community has officially adopted several Directives and Regulations related to the registration of medical devices. The Medical Device Regulation 2017/745 came into effect on May 25, 2017, and became mandatory on May 26, 2021, replacing the former MDD and AIMDD.
CE compliance requirements fall into two broad categories: Quality System Requirements — covering development and manufacturing processes — and Safety & Reliability Requirements, encompassing biocompatibility, software validation, electrical safety, EMC, and clinical evidence.
The specific requirements depend on product classification and risk level, making expert regulatory guidance essential for successful CE marking and European market access.
How to Obtain CE Marking & EU Device Registration
A structured pathway to CE marking compliance under EU MDR and IVDR — from product classification through Notified Body certification and EUDAMED registration.
Product Classification
Determine the device classification and risk level under EU MDR 2017/745 or IVDR 2017/746. Classification dictates which conformity assessment route and requirements apply to your product family.
Class I / IIa / IIb / III
Establish a Medical Quality Management System
Implement and maintain a Medical QMS compliant with ISO 13485 and EU MDR requirements. The QMS covers design, development, manufacturing, and post-market processes.
QMS / ISO 13485
Prepare Technical File / Design Dossier
Compile a Technical File or Design Dossier for each product family, demonstrating conformity with all applicable EU MDR/IVDR requirements including safety, performance, and clinical evidence.
Technical File
Product Testing & Standards Compliance
Test the device to demonstrate compliance with applicable harmonised standards, covering biocompatibility, software validation, electrical safety, EMC, and performance evidence.
Safety & Performance
Appoint a European Authorised Representative
Non-EU manufacturers must contract a European Authorised Representative (EAR) established in an EU member state to act as the regulatory liaison with Competent Authorities.
Non-EU Manufacturers
Engage a Notified Body
For Class IIa, IIb, and III devices, contract a designated Notified Body to audit your QMS and review Technical Files/Design Dossiers as part of the conformity assessment procedure.
Class IIa / IIb / III
Affix CE Marking
Upon successful conformity assessment, affix the CE symbol to your product in accordance with stipulated requirements, enabling lawful sale across all European Community member states.
CE Symbol
Register with a European Competent Authority
Register the company and list the product with at least one European Competent Authority and comply with EUDAMED database registration requirements.
EUDAMED
Post-Market Surveillance & Lifecycle Compliance
Maintain ongoing post-market surveillance, vigilance reporting, and periodic safety update reports (PSURs) as required under EU MDR/IVDR to sustain CE marking validity.
Post-Market
EU MDR vs EU IVDR — Key Differences
Understanding which regulation applies to your device is the critical first step in your European market access strategy.
EU MDR 2017/745 — Medical Device Regulation
Mandatory from May 26, 2021 — replaces MDD and AIMDD
Applies to all medical devices and active implantable devices sold in the EU
Replaces the former Medical Device Directive (MDD 93/42/EEC)
Introduces stricter clinical evidence and post-market surveillance requirements
Devices classified as Class I, IIa, IIb, or III based on risk
Notified Body involvement required for Class IIa, IIb, and III devices
EUDAMED registration mandatory for all device manufacturers
EU IVDR 2017/746 — In Vitro Diagnostic Regulation
Mandatory from May 26, 2022 — replaces former IVDD
Applies to all in vitro diagnostic medical devices sold in the EU
Replaces the former In Vitro Diagnostic Directive (IVDD 98/79/EC)
Introduces a new risk-based classification system (Class A, B, C, D)
Significantly expands the scope of Notified Body involvement
Requires performance evaluation and scientific validity documentation
EUDAMED registration and UDI assignment required for all IVDs
RABT’s EU MDR & CE Marking Services
Comprehensive regulatory support across the full EU MDR, IVDR, and post-Brexit compliance lifecycle.
EU MDR / IVDR Transition Strategy
Regulatory strategy for transitioning existing CE marked devices to comply with new EU MDR and IVDR regulations.
Product Classification & Registration
Expert device classification under EU MDR/IVDR risk-based rules and full European product registration support.
Technical File Compilation
Regulatory support for CE Technical File compilation and Design Dossier preparation aligned with EU MDR/IVDR requirements.
Design History File Support
Regulatory support for product development documents including design history files and risk management documentation.
MDSAP Compliance & Certification
Support for Medical Device Single Audit Program (MDSAP) compliance and certification for global regulatory recognition.
European Authorised Representative (EAR)
EAR services for non-EU manufacturers in full compliance with EU MDR 2017/745 and IVDR 2017/746 obligations.
Brexit Transition & UK Responsible Person
Remediation and action plan for Brexit transition and UK Responsible Person services for the post-Brexit regulatory framework.
Gap Analysis — Technical Docs & QMS
Comprehensive gap analysis of technical documents and quality systems against EU MDR/IVDR requirements to identify remediation priorities.
Regulatory & Market Intelligence
Proactive monitoring of EU regulatory developments, guidance updates, and market access intelligence for medical device manufacturers.
Notified Body & Health Agency Liaison
Direct liaison and support with Notified Bodies and European Health Agencies throughout the conformity assessment process.
EUDAMED Compliance
End-to-end support for EU database (EUDAMED) registration, UDI assignment, and ongoing data maintenance obligations.
End-to-End EU MDR Project Management
Full project management for EU MDR, IVDR, post-Brexit transition, and EUDAMED compliance programmes from strategy to completion.