European Parliament Adopts New Rules To Tighten IVD, Medical Device Regulation

By Jof Enriquez,
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The European Parliament has voted to enact final legislation for long-awaited Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR) that will tighten how these products are marketed in Europe. These regulations will fully apply after a transition period of three years for medical devices, and five years for in vitro diagnostic devices.

Safety rules governing these products were harmonized back in the 1990s, and rapid technological developments in ensuing years, as well as much-publicized scandals involving breast implants and metal hips, spurred EU countries to call for revamped regulations in 2012. After numerous delays, the Council of the European Union completed its final versions in February, which set up this week’s affirmative legislative vote by the European Parliament.

"The Commission heartily welcomes the final compromise which contains a series of crucial improvements to the current system," said European Commissioner of Health and Food Safety Vytenis Andriukaitis, according to RAPS.

Among the most important of the new rules are tougher premarket reviews of high-risk devices (including aesthetic devices, such as colored contact lenses and liposuction equipment, and nanomaterials that come into contact with membranes inside the body), plus tighter regulation and increased responsibilities for notified bodies. The new rules also will introduce simplified one-time product registration at the EU level, closer coordination of member states in market surveillance, unique device identifier (UDI) requirements, and the setting up of a comprehensive EU database on medical devices (EUDAMED) by 2020.

In addition, a new Medical Device Coordination Group (MDCG), composed of Member States experts and chaired by the Commission, will be established to strengthen market surveillance in the EU market.

"The new rules significantly tighten the controls to ensure that medical devices are safe and effective and at the same time foster innovation and improve the competitiveness of the medical device sector," the European Commission stated in a press release. "The new rules also better reflect the most recent scientific and technological progress and set the gold standard for medical device regulation globally. The revised rules also provide the conditions needed to consolidate the role of the EU in the long-term as a global leader in the sector."

The text for the updated Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR) will be published in the Official Journal of the European Union in May, with the official transition period starting in June. The new MDR regulations will take full effect in 2020, whereas new IVDR regulations will be fully implemented in 2022.

MedTech Europe CEO Serge Bernasconi welcomed the European Parliament’s final vote, stating, "the Council and the European Parliament have recognised the specific and differing nature of the two types of technologies when building these two new regulations and we welcome this vote that allows industry to begin the work needed to transition the two sectors to the new rules within the set timeframes."