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Home / Medical Devices / Medical Devices Legislation

Medical Devices Legislation

Regulatory Framework for Medical Devices

 

EU Legislation

The European regulatory framework for medical devices ensures the highest standards of safety, performance, and transparency. On 5 April 2017, the European Parliament and Council adopted two landmark regulations:

Regulation (EU) 2017/745 (MDR)
This regulation governs the clinical investigation, production, and sale of medical devices intended for human use. It serves as an amendment to to medical device legislation in Europe while repealing Council Directives 90/385/EEC and 93/42/EEC.

Regulation (EU) 2017/746 (IVDR)
Regulation 2017/746 establishes comprehensive guidelines for the placement and use of in-vitro diagnostic medical devices in the European market. It repeals Directive 98/79/EC, ensuring a modernized and harmonized approach to regulatory compliance.

Both regulations emphasise rigorous clinical evaluation, robust post-market surveillance, and traceability to safeguard public health.

Maltese Legislation

Malta aligns its local regulations with the EU framework to ensure consistency and adherence to international standards. Key national regulations include:

These regulations address the safe provision, distribution, and testing of medical devices on the Maltese market.

This robust legislative and regulatory structure underscores Malta's commitment to ensuring the safety, quality, and efficacy of medical devices and in-vitro diagnostics for public use. For more detailed information, please contact the Medical Device and Pharmaceutical Collaboration Directorate at devices.medicinesauthority@gov.mt.