Another Notified Body Bows Out Ahead of EU MDR: 'Investment Too High’
Swiss notified body (NB) QS Zürich AG has decided that it will not pursue designation under the new EU medical devices regulation (MDR), although EN ISO 13485 support will remain.
Ursula Roesler, head of medical devices at QS Zürich AG, told Focus that the medical device department will be closed by the end of October. As far as why the decision was made, Roesler said, “It was a business decision of the CEO—the investment was too high for a small NB like QS Zürich AG.”
The company has worked as an accredited certification body for management systems and as an NB for medical devices in the EU since 1998.
The news from Switzerland follows a decision from London-based Lloyd's Register Quality Assurance (LRQA) last week to withdraw its NB servicesunder the EU’s current medical device and in vitro diagnostic directives and to not apply to be an NB under the new MDR or the in vitro diagnostic regulation (IVDR).
LRQA directed clients to choose an alternative NB and the firm established a team to help with transition activities, with the goal of minimizing the risk of disruption.
Similarly, the Spanish Agency of Medicines and Medical Products (AEMPS), the only Spanish NB, said in late May that it will no longer accept device applications from new clients for CE marking and cease to process new certificate applications from existing clients beginning 31 July 2019.
Despite the shifting landscape and as more NBs are expected to drop out, the European Commissioner for Health and Food Safety last Friday sought to reassure device companies that an extension to the May 2020 MDR deadline would not be necessary. Experts, however, have questioned the prediction that about 20 NBs will be designated before the end of 2019.
Only two NBs have been designated against MDR so far and none have been designated against IVDR. The European Commission noted on Monday that the wider scope of IVDR will result in about 85% of all IVDs being subject to NB oversight, up from 20% under the current directive.
Posted 18 June 2019 | By Zachary Brennan