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…

The first reference laboratories were designated with Implementing Regulation (EU) 2023/2713: 1. EU reference laboratories for devices intended for detection or quantification of markers of hepatitis or retrovirus infection: a) EU-Referenzlabor für In-vitro-Diagnostika am Paul-Ehrlich-Institut, Paul-Ehrlich-Straße 51-59, 63225 Langen, Deutschland b) Instituto de Salud Carlos III, Carretera de Majadahonda — Pozuelo, Km. 2.200, 28220 Majadahonda…

As of March 20, 2023, Regulation (EU) 2023/607 was published to smoothen the transition from MDD (and AIMDD) to MDR certification of devices on the market and to assure availability of medical devices on the European market. Manufacturers of devices certified according to Medical Device Directive (MDD), also known as “legacy devices” according to MDR…

On 20 Mar. 2023, the European Commission published Regulation (EU) 2023/607 extending the transitional periods for devices requiring a Notified Body for conformity assessment under Regulation (EU) 2017/745 (MDR). UPDATE: On July 2023 the European Commission has additionally published a updated Q&A document on the extension of the timelines. The information can be found on…

As of Dec. 1, 2022, the European Commission published the definitions of common specifications for the devices without a medical purpose listed in Annex XVI of the MDR (Regulation (EU) 2022/2346. The implementing regulation contains, in particular, specifications for the conformity assessment procedure and the requirements to be taken into account – so-called common specifications.…