Europe
Europe represents one of the most regulated and structured markets for medical devices, thanks to the harmonization of legislation among Member States and a broad consumer base.
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Regulatory Framework
The market is regulated by EU Regulation 2017/745 (MDR) for medical devices and EU Regulation 2017/746 (IVDR) for in vitro diagnostics.
Device Classification:
- Class I: Low risk
- Class IIa, IIb: Moderate risk
- Class III: High risk
Specific Local Requirements
| Language | Documentation must be in the language accepted by the destination country. |
| EU Representative (Authorized Representative) | Mandatory for non-EU manufacturers. |
| CE Marking | Required for commercialization. |
Challenges and Operational Advice
- Complex process: MDR has increased documentation requirements and evaluation timelines.
- Notified Bodies: Limited availability, evaluations must be booked well in advance.
Why Choose ISEMED
- MDR/IVDR EXPERTISE
Qualified consulting on the new European regulations. - COMPLETE SUPPORT
Assistance with dossier preparation and contact with Notified Bodies.
FAQ
- Is a local representative required? Yes, for non-EU companies.
- Documentation language? Depends on the country.
- Certification duration? 5 years.