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The EU MDR (European Union Medical Device Regulation), formally known as Regulation (EU) 2017/745, is the
set of laws that governs the production, sale, and distribution of medical devices within the European Union
The need for better safety standards which arose from various scandals especially the PIP breast implant incident and the fast development of health applications and software drove the change from a Directive to a Regulation.
All organizations which export medical devices to the European Union and those which collaborate with European Union entities must meet compliance standards of the EU Medical Device Regulation (EU MDR) which governs medical devices in India.
1. Medical Device Manufacturers: Indian manufacturers who develop medical devices for the EU market need to ensure their products meet EU MDR standards.
2. Exporters: Medical device exporting companies to the EU must learn and follow EU MDR regulations which govern their compliance obligations.
3. Authorized Representatives: Indian manufacturers need to select an authorized representative who operates from the EU to support their EU regulatory compliance efforts.
4. Healthcare Providers: Indian hospitals and clinics which work with EU organizations or utilize imported medical devices must understand the EU standards which govern quality and safety.
5. Research Institutions: Organizations which conduct clinical trials or research with EU partners must operate according to EU MDR regulations. Indian stakeholders must understand EU MDR requirements to enter and succeed in the EU medical device market.
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