Compliance4India · Services
End-to-end EU MDR compliance and CE certification for Indian medical device manufacturers — managed entirely by Compliance4India, from your factory floor to your first shipment into the EU.
CE marking is the regulatory certification required to legally place a medical device on the market across the European Union and European Economic Area. For devices manufactured in India, achieving CE certification means demonstrating conformity with the EU Medical Device Regulation (EU MDR 2017/745) — covering everything from quality management and clinical evidence to labelling and post-market surveillance.
For most medical devices — Class IIa and above — self-certification isn't permitted. An independent EU Notified Body must review your technical documentation and audit your manufacturing facility before a CE Certificate can be issued. Once granted, that certificate gives access to all 27 EU member states plus the EEA under a single regulatory framework, with no country-by-country approvals required.
Compliance4India manages this entire journey for Indian manufacturers — as a single point of accountability — so your team can stay focused on manufacturing while regulatory compliance is handled for you, start to finish.
Every medical device follows the same regulatory backbone, though the specific standards and testing requirements depend on your device's classification. Compliance4India manages each stage below on your behalf.
Compliance4India determines your device's MDR risk class and confirms whether Notified Body review is required.
Design controls, sterility assurance and CAPA systems are built and documented at your Indian facility.
Testing against the applicable product and biocompatibility standards is coordinated through accredited Indian laboratories.
GSPR checklist, risk file, biocompatibility evaluation, CER, IFU and labelling drafts are prepared by Compliance4India.
Mandatory for any manufacturer outside the EU. Compliance4India appoints and manages your EU AR throughout.
Your company and each device SKU are registered in EUDAMED, with a Single Registration Number obtained on your behalf.
Compliance4India selects the right accredited Notified Body and manages the application early to protect your timeline.
The Notified Body reviews your documentation remotely; Compliance4India manages every query on your behalf.
EU MDR requires a physical audit of your factory. Compliance4India prepares your team and manages the entire visit.
Once no major non-conformities remain, the Notified Body proceeds to issue your QMS and CE certificates.
Issued by the Notified Body under its EU legal authority — India is not part of the EU, so the certificate is issued in Europe, valid for 5 years across all 27 member states.
Prepared by Compliance4India per MDR Annex IV and signed by your authorised person in India.
CE mark, Notified Body number, UDI, manufacturer and EU AR details are finalised across your packaging.
Compliance4India helps identify a suitable importer to receive, store and distribute your product across the EU.
One CE Certificate provides access to all 27 EU member states plus Norway, Iceland and Liechtenstein.
Periodic Safety Update Reports are prepared by Compliance4India on the required cycle.
Serious incidents are reported within 15 days via EUDAMED, managed by Compliance4India.
Annual surveillance audits and full recertification every 5 years, coordinated at your Indian facility.