New European Medical Devices and In Vitro Diagnostics Regulations to Take Effect


On 5th May 2017, after almost five years of negotiations, the European Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) were formally published in the Official Journal of the European Union.  The regulations will officially take effect on the twentieth day following publication, with a three-year transition period for the MDR and a five-year transition period for the IVDR. 

The goal of the new regulations is to modernise the existing legislative framework for the marketing of medical devices and to close any legal gaps, thereby supporting innovation and the competitiveness of the medical device industry.  The regulations should further strengthen patient safety, notably through the introduction of more stringent procedures for conformity assessment and post-market surveillance, and through requirements on manufacturers to generate clinical data providing evidence on safety, performance and any undesirable side effects.  They should also allow rapid and cost-efficient market access for innovative medical devices. 

As a result, the new regulations are considerably more extensive than the current directives, with the MDR increasing from 23 to 123 articles and the IVDR increasing from 24 to 113 articles. Key elements of the new regulations include the following:

  • Increased scope for medical devices with medical devices and active implantable medical devices combined, as well as the inclusion of products manufactured utilising non-viable human tissues or cells, and certain products without an intended medical purpose
  • Introduction of a new risk-based classification system for IVDs, and the inclusion of high-risk devices manufactured and used within a single health institution (i.e. laboratory developed tests), genetic tests, companion diagnostics and software
  • Requirement for manufacturers to appoint a “person responsible for regulatory compliance”
  • Permission granted to Member States to allow reprocessing and further use of single-use devices, where permitted by national law
  • Supply of implant cards to patients with an implanted device
  • Introduction of a Unique Device Identification system
  • Expansion of the European Database on Medical Devices to increase transparency and facilitate flow of information
  • Increased oversight of Notified Bodies by Member States
  • Introduction of an expert oversight committee for high-risk device conformity assessments
  • Additional clinical and post-market requirements, including making certain information is publicly available

If you require assistance in understanding these new regulations and how they impact your business, contact ICON at www.iconplc.com/devices for more information. Our medical device regulatory experts are currently evaluating the changes and are available to support you and your business throughout the transition period.

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