Our Tuttlingen branch has a new home: as of this week, we can be found in the Drei-Kronen-Hof in the centre of Tuttlingen – just a few minutes’ walk from our previous location on Rathausstraße. The Drei-Kronen-Hof offers the ideal opportunity to stay rooted in the region while continuing to grow. With 15 modern workspaces,…

At our February information sessions on the transition from the IVDD to the IVDR, we had in-depth discussions about common errors in the submission of technical documentation. Many manufacturers face similar challenges – which is why we, as a Notified Body, have now published the most frequent non-conformities on our website. What can you expect?…

With the publication of revision 4 of the MDCG 2022-16 “Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746“ in March of this year, amongst other SARS-CoV-2 devices were re-classified. In summary, SARS-CoV-2 devices for professional use are classified as class B, whereas SARS-CoV-2 devices intended for lay use are…

As you are no doubt already aware, an amendment to DIN EN ISO 9001 has been published. The reason for this amendment is that climate change is to be given greater consideration in all management standards. To this end, the management system standards have been supplemented by so-called ‘amendments’. The amendments to take account of…

1st October 2024 marks the transition to operations for European Reference Laboratories (EURLs) for Class D in vitro diagnostic (IVD) medical devices. From October 1st 2024 the EURLs are intended to carry out tasks referred to in Article 100(2) of Regulation (EU) 2017/746. See press release of Team-NB

The adaptation of the transitional periods for the IVDR, published by the EU Commission in the form of  Regulation (EU) 2024/1860, came into force on 9. July 2024 and is intended to give manufacturers and notified bodies more time to implement the requirements of the IVDR. The extended transitional periods apply exclusively to legacy devices with an existing conformity…

The Basic UDI-DI is an important key in product documentation (e.g. certificates, technical documentation, vigilance notifications and PSUR, SS(C)P, etc.) and also serves as an access key to the product-related information in the European database for medical devices (EUDAMED). The Basic UDI-DI is a useful way of grouping several similar variants of a medical device.…

At present, there is no need to request a current declaration of conformity, if there are no changes, in addition to the original declaration of conformity issued before the date of application of the MDR (26 May 2021) or IVDR (26 May 2022), with reference to Art. 120 MDR or Article 110 IVDR. However, in…

At present, there is no need to request a current declaration of conformity, if there are no changes, in addition to the original declaration of conformity issued before the date of application of the MDR (26 May 2021) or IVDR (26 May 2022), with reference to Art. 120 MDR or Article 110 IVDR. However, in…

Reminder for the necessity of the submission of Periodic Safety Update Reports. With a certain frequency manufacturers of medical devices of risk classes IIa, IIb and III have to create a PSUR (Periodic Safety Update Report) according to MDR Art. 86 and manufacturers of In-vitro-Diagnostics of risk classes C and D have to create a…