August 23, 2019
Notified Body Medical Device Regulation

Two New Notified Bodies in Germany and Italy

As the 3-year transitional period of the new medical device regulation EU 2017/745 is coming to an end, concerns of the industry about the implementation are not calming down. The European Commission intends to have 20 notifies bodies appointed by the end of 2019. Does this goal seem attainable?

Until last week only two notified had been designated. At the same time some certification bodies have announced they would not seek designation according to the new regulations and will, in fact, withdraw from the market; such as Lloyd's Register Quality Assurance , UL International and Swiss QS Zürich.

The first notified body to have been designated according to the new regulations was the BSI Assurance UK Ltd. The BSI Group is based in the UK but has migrated most of their medtech clients and certificates to their Dutch subsidiary (BSI to open a second EU Notified Body based in the Netherlands) in order to not be affected by the consequences of Brexit.

The second company that was appointed as notified body for the new mdr was the German TÜV SÜD Product Service GmbH (TÜV SÜD Receives Designation for MDR).

This week to more certification companies were listed in NANDO, the EU's database of notified bodies. First Germany's DEKRA Certification GmbH was published. Later in the week the Italian certification company IMQ Istituto Italiano del Marchio di Qualità S.p.A. was revealed as the fourth notified body.

Further, it is known that the newly established Austrian company QMD Services has recently begun the process to receive designation as a notified body under the European Union’s medical device regulation (Österreich soll erste Benannte Stelle bekommen), as well as the Spanish Agency of Medicines and Medical Products (AEMPS). The Spanish agency expects to complete the MDR evaluation and designation process during the second half of 2020.

With the amount of notified bodies, as of right now, it is highly questionable as to whether medical device manufacturers will manage to complete the process of recertification to continue European sales by May 26, 2020.

The new in-vitro diagnostics regulation has a five-year transition period running to May 26, 2022. No notified bodies have to-date been appointed according to IVDR 2017/746.

Related German Articles:
Gegenstimme zur Forderung nach längerer Übergangszeit

Macht der Mangel an Benannten Stellen Unternehmen erpressbar?

Erste Maßnahme des MDR-Soforthilfe-Programms in Baden-Württemberg gestartet

© Joseph Heeg / MTME Medtech Media Europe