The European Parliament has voted to enact final legislation for Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR) that will tighten how these products are marketed in Europe. The MDR will replace the EU’s current Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC).
As announced by the European Commission, the new rules will take effect in spring of 2020 for medical devices and spring of 2022 for in-vitro diagnostics.
This overhaul of existing regulations was launched in 2012 to address diverging interpretations of the rules across the EU and to better protect public health and safety following specific incidents related to breast implants and metal-on-metal hip implants. They are also meant to better accommodate the rapid pace of technological development.
Key changes in the new regulations include:
- Expansion of the definition of a “medical device” – The new definition will encompass devices designed to diagnose or predict disease occurrence and prognosis; aesthetic products without an intended medical purpose such as colored contact lenses; products intended to clean or sterilize medical devices; devices that control or support conception; and software that meets the MDR definition of a medical device.
- A new risk classification system for in vitro diagnostic medical devices – This move is intended to bring the EU in line with international guidelines.
- Tighter regulation of and increased responsibilities for notified bodies – Notified bodies will be subject to stricter designation requirements, and the joint assessment process introduced in 2013 will continue. Notified bodies will also be given increased post-market surveillance authority, including un-announced factory inspections, product sample checks, and product testing.
- Greater scrutiny of high-risk devices – For certain class III devices, notified bodies will be required to consult with a panel of independent experts at the EU level. While a notified body will not be bound by the opinion of the panel, it will have to provide a justification for not following the guidance. High-risk devices will also have greater clinical requirements, with less emphasis on equivalence and more focus on data that demonstrates safety and performance.
- More transparency of medical device data – The new regulations will give more constituencies, including public entities, access to the centralized EUDAMED database. Sponsors of clinical investigations will be required to publish the results of their studies (and a summary in layman’s language) to the database within one year of completion. Other EUDAMED enhancement will include the availability of data from unique device identifiers to increase the ability of manufacturers and authorities to trace and/or recall devices; requirements for post-market follow-up data in order to provide on-going assessment of potential safety risks; and a newly-introduced summary of safety and performance for all Class III and implantable devices.
According Jan Pietzsch, Director for Health Economics and Value at the Stanford Byers Center for Biodesign, the new rules may increase the regulatory burden for companies seeking clearance to market their products in the EU. However, he said, “I don’t see this as a dramatic shift. Regulatory clearance in Europe should still be swifter in most cases, compared to the U.S.” He added, “The current changes are an important step to address some previous limitations in the regulations, and they should ultimately benefit patients and manufacturers alike.”
- European Commission Press Release: https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/revision_en
- European Commission Fact Sheet: http://europa.eu/rapid/press-release_MEMO-17-848_en.htm