This Regulation entered into force on 25 May 2017, after a three-year transition period, and it will be applicable on 26 May 2020, considering the necessity of the organizations involved in Medical Devices sector to comply with the Regulation’s requirements within this date.
News and background
The new Regulation introduces several important changes: from a greater control foreseen for the technical documentation, to a more rigorous clinical evaluation and post-market surveillance, allowing a better traceability of the devices through the supply chain.
Added to this is the widening of the product definition, a greater involvement of Notified Bodies and obligations not only for manufacturers but also for importers and distributors.
The beginning of this long process of change is dated September 26, 2012, when, after a public consultation started in 2008, the European Commission published a proposal for a regulation, later revised by the European Parliament and Council in the following years.
Find out more
- Regulatory framework - EU Regulation 2017/745
- Press Release - "New EU rules on medical devices to enhance patient safety and modernize public health" - Brussels, 5 April 2017