Updated: Notified Bodies Prep for Post-May Designations

Regulatory NewsRegulatory News | 11 February 2020 |  By 

As the European Commission updated its NANDO database on Thursday to unveil the 10th notified body designation under the Regulation (EU) 2017/745 (MDR), other notified bodies designated under the outgoing 93/42/EEC Medical devices (MDD) told Focus they are either awaiting designation or did not apply.

Some but not all notified bodies under MDD have offered updates on their websites as to the progress with their designations under MDR, and Focus reached out to several companies that did not offer any information on MDR.

Martin Novotný, business manager of medical devices at the MDD-designated Czech notified body EZÚ, told Focus via email on Friday that his firm "did not apply for the new MDR," although on Monday he clarified, "We have not submitted an MDR application yet, but we are working hard to prepare it." A spokesperson also clarified that the company is awaiting word from the Czech Ministry of Industry and Trade.

London-based Lloyd's Register Quality Assurance (LRQA) and Switzerland’s QS Zürich AG said last summer that they would not apply under MDR.

Tomáš Závišek, head of the medical device certification department in another Czech notified body, the Institute for Testing and Certification, told Focus via email that his firm did apply and expects designation during the second half of 2020. 

Vesna Odar, sales manager at Slovenian notified body SIQ, told Focus that the firm applied for designation under MDR in February 2018 and is in the process of obtaining a designation.

Similarly, Nina Eschweiler, coordinator of certification at the notified body Berlin Cert in Germany, told Focus that she’s also expecting designation after the 26 May date of application for MDR, and estimating that the firm’s designation will come in the third quarter of 2020.

Daniel Kraushaar, head of the business unit for Stuttgart, Germany-based Mdc medical device certification GmbH, told Focus he expects his firm will be designated “within the next months.”

A spokesperson for Frankfurt, Germany-based DQS Medizinprodukte GmbH also told Focus that it is in the process of obtaining a designation, which is expected at the end of the second quarter of this year.

Other notified bodies under MDD (the European Commission says there are 49 total, if the Turkish notified bodies are excluded, and 44 have applied under MDR) offered updates on their MDR designation processes on their websites.

For instance, Slovakia’s 3EC International disclosed that an on-site inspection was conducted in the first week of June 2019 as part of its designation process.

Poland’s Centre for Testing and Certification underwent an on-site inspection last November and said it expects designation in April or May.

Italy’s Ente Certificazione Macchine also said that last September it received a joint assessment by the European Commission and Italian national authorities as part of its MDR designation process.

Sweden’s Intertek said it submitted its application for MDR to the Swedish Medical Products Agency in January 2018.

In addition, SGS Belgium said its designations under MDR and the In Vitro Diagnostic Regulation (IVDR), set to take effect in 2022, are still pending

Germany’s TÜV NORD CERT GmbH said it submitted its application for designation under MDR in 2018. And Germany’s DQS also said that it’s applied under MDR. Austria’s QMD Services said it has applied under MDR too.

Editor's note: Updated on 2/10/20 with additional comments from Czech notified body EZÚ. Updated again on 2/11/20 with comment from DQS Medizinprodukte GmbH.


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