Germany-based TÜV SÜD Product Service GmbH Zertifizierstellen on Wednesday became the second notified body (NB) to be designated and notified under the EU Medical Devices Regulation (MDR), which goes into effect next May.
TÜV SÜD is now listed
alongside BSI UK, which was the first NB designated
last January, in the European Commission’s New Approach Notified and Designated Organisations (NANDO) database.
According to MedTech Europe, TÜV SÜD submitted its application in November 2017 and had its joint assessment in April 2018, meaning the procedure lasted 18 months.
TÜV SÜD’s designation under the EU’s in vitro diagnostic regulation (IVDR), which goes into effect in May 2022, is still ongoing, with a notification expected by the end of this summer.
Although the two designations are welcomed by industry, a shortfall of NBs designated under EU MDR/IVDR is still expected
. And questions still linger over Brexit’s impact on NBs. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has said that a no-deal scenario will mean UK-based notified bodies are no longer recognized by the EU. According to BSI
, about half of all medical devices in the EU use UK-based notified bodies.
According to the latest figures on designations from Team-NB and the European Commission, 39 NBs have submitted complete applications under MDR and 10 have completed applications under IVDR.
But of those, on-site assessments have been conducted for 27 NBs seeking designation under MDR and six under IVDR. And only two notified bodies have submitted corrective and preventive action (CAPA) plans to DG Sante under IVDR, while 11 notified bodies have submitted CAPAs under MDR.
MedTech Europe said it expects about 20 NBs to be notified under MDR by the end of 2019.
Notification of a Body in the framework of a technical harmonization directive