Indian medical device makers, from disposables and surgical instruments to diagnostics and equipment, need CE marking under the Medical Device Regulation (EU) 2017/745 (MDR) to sell in Europe. MDR is far stricter than the old directives. Most devices need a Notified Body, strong clinical evidence, an EU Authorised Representative and registration in EUDAMED. Global Approbation guides you from classification to certificate.
EU MDR at a Glance
| Classes | I (incl. Is, Im, Ir), IIa, IIb, III. Only Class I (non-sterile, non-measuring, non-reusable surgical) can be self-declared |
|---|---|
| Quality system | QMS per Article 10, usually built on ISO 13485 |
| Technical documentation | Annex II/III files, clinical evaluation, risk management (ISO 14971), PMS and PMCF plans |
| EU Authorised Representative | Mandatory for non-EU manufacturers |
| EUDAMED | Actor registration, UDI/device registration, Notified Body & certificates, and market surveillance modules mandatory from 28 May 2026 |
| Legacy devices | Transition extended by Regulation (EU) 2023/607 to 2027/2028 depending on risk class, subject to conditions |
Devices We Support
- Disposables & syringes
- Surgical instruments
- Orthopaedic implants
- Wound care & dressings
- Diagnostic & monitoring equipment
- Hospital furniture
- Dental products
- Rehabilitation aids
How Global Approbation Handles MDR
- Classification. Device class under Annex VIII rules and the conformity route.
- Gap analysis. Your QMS (ISO 13485) and CDSCO files compared with MDR requirements.
- Technical documentation. Clinical evaluation, risk management, labelling/IFU, UDI and PMS documents.
- Notified Body. Application, audits and query handling through to the certificate.
- EU AR & EUDAMED. Authorised Representative appointment and EUDAMED actor and device registration.
EU MDR: Frequently Asked Questions
Can I self-certify my device under MDR?
Only certain Class I devices (non-sterile, without a measuring function, not reusable surgical instruments). All others need a Notified Body.
Do I need an EU Authorised Representative?
Yes. Manufacturers outside the EU must appoint an EU Authorised Representative, named on the labelling.
Is EUDAMED mandatory now?
Four EUDAMED modules (actor registration, UDI/device registration, Notified Bodies & certificates, and market surveillance) became mandatory on 28 May 2026.
Does CDSCO registration help?
Your CDSCO dossier and ISO 13485 QMS are a strong base, but MDR requires EU-specific clinical evidence, documentation and Notified Body certification.
Regulations, standards and deadlines change. Scope, testing route and timelines are confirmed product by product after our applicability review. Global Approbation is a consultancy and does not itself issue certificates; approvals are granted by the relevant authority, accredited laboratory or certification body.