Dive Brief:

• Italian certification company IMQ is the fourth notified body designated under the European Union Medical Device Regulation, according to the European Commission Tuesday.
• IMQ joins Germany's Dekra and TÜV SÜD, as well as the United Kingdom's BSI, as the only four bodies designated less than a year before the new device regulations take effect May 26, 2020.
• The device industry has been vocal pushing the EC to delay the effective date of the MDR amid a slate of notified bodies pulling back from the medical device space, citing costs to meet the new standards and the looming possibility of a no-deal Brexit. Lloyd's Register Quality Assurance, UL International and Switzerland's QS Zürich have all announced they do not plan to seek MDR designation.

Dive Insight:

The new European medical device regulations, passed in May 2017, are intended to boost the intensity of pre- and postmarket review for medical devices "in order to meet common safety concerns."

But the designation of EU notified bodies, which are responsible for certifying medical products under the new regulation, has lagged behind and several notified bodies have exited the sector, stoking fears there won't be adequate capacity to deal with the new regulation's requirements. The IVDR comes into effect in May 2022, two years after the MDR.

But device industry groups in the United States and Europe have expressed concern the regulatory system will not be ready in time, leaving member companies in limbo.

In July, MedTech Europe called for the acceleration of the designation of notified bodies for MDR, saying patients and healthcare systems could be put at risk if action is not taken.

Germany and Ireland representatives to the European Council raised concern in June the capacity of notified bodies may be inadequate ahead of the MDR implementation.

In July, Spain's Agency of Medicines and Medical Products announced it had began the process of applying for designation as a MDR notified body, but the agency does not expect to finish until the second half of 2020.

The additional designations bring the total of notified bodies designated under the new rules to four, well below the 20 the EC reportedly has said it expects to be designated by the end of the year.