The medical devices’ Regulations and the role of Standards
With the new medical devices and in-vitro diagnostic medical devices Regulations (MDR and IVDR) published on 5 May 2017 by the European Commission, the long process of revising the European regulatory framework has ended. The Regulations pose new challenges to the various stakeholders involved in the sector due to the changes that they have introduced. They have expanded the scope of products, there are more rigorous requirements for clinical evaluations as well as changes to clinical investigations, mandatory unique device identification (UDI) mechanisms, and increased post-market oversight by European Notified Bodies. In addition, the IVDR introduces a new risk-rule classification system based on the Global Harmonization Task Force’s rules for classification, which considers patient impact for the first time.
The Regulations recognise the important role of standardisation in the field of medical devices. By complying with harmonised standards, manufacturers may demonstrate conformity with the general safety, performance, quality and risk management requirements of the Regulations, and thereby gain access to the European market. In addition to standardisation, the Regulations authorise the European Commission to publish common technical specifications that will represent state-of-the art and will be part of the products’ evaluation process. Several questions remain open, however, regarding the development of the common specifications and their co-existence with harmonised standards.
Given the complexity of the new regulatory framework, the scope of the changes it has introduced, and the short timeframe for the transition period, it is important to provide an open space for discussion and exchange of information and ideas regarding the new Regulations and the way forward. This is the objective of the Seminar on ‘The new regulations on medical devices and related standards: ensuring a successful transition’, which is organised by CEN and CENELEC and will take place on 21 September 2017. The focus of the seminar will be on standardization and its role in supporting the new Regulations, the future of harmonised standards under the Regulations, and the need to ensure a smooth and successful transition for the benefit of European citizens and industry.
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