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The final versions of the European Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulations (IVDR) had just been released by the European Council.

On 7 March 2017, the 28 members of the European Council had voted to adopt the MDR and the IVDR. According to the schedule, the European Parliament would vote in April 2017. If adopted, the MDR and the IVDR could be published in May 2017 and enter into force in May 2017. Accordingly, the MDR and the IVDR would become applicable in 2020 and 2022 respectively.

The contents of the final versions was still the same as that in the agreement reached between the European Council and European Parliament in May 2016. When comparing with the current directives, both regulations generally strengthen the pre-market requirements and post-market surveillance. As the new regulations will impact nearly every medical device in the EU, device manufacturers are encouraged to consider their existing products from the perspective of new regulations to avoid un-necessary workload when selling their device in the EU market.

For more information, please contact:

Certification and Business Enhancement
Tel: (852) 2765 3620

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SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 90,000 employees, SGS operates a network of over 2,000 offices and laboratories around the world.