The European Commission has officially proposed extended transition timelines for legacy devices under Regulation (EU) 2017/745 on medical devices (MDR). Please note that this is a proposal and still must… Read More
Manufacturers who are not based in the EU must have an authorised representative. The EU has published its first guidance, MDCG 2022-16, a 10-page document, clarifying the role of the… Read More
It was obvious that the industry and also EU country authorities grew increasingly alarmed with regards to the approaching 26 May 2024 deadline. It marks the day where manufacturers of… Read More
The notified body association, TEAM-NB, has issued a position paper, Best Practice Guidance for the Submission of Technical Documentation under Annex II and III Medical Device Regulation (EU) 2017/745. The… Read More
A subgroup of the Medical Device Coordination Group (MDCG) published its first borderline manual under the medical device regulations titled “Manual on borderline and classification for medical devices under Regulation… Read More
The European Commission’s Medical Device Coordination Group (MDCG) has recently published a position paper on the transition to Regulations (EU) 2017/745 and 2017/746 on medical devices and in vitro diagnostic… Read More
The European Union Agency for Cybersecurity (ENISA) has warned that there is a danger of attacks on devices and digital health systems despite measures under Regulations (EU) 2017/745 and 2017/746… Read More
The European Commission adopted Implementing Regulation (EU) 1022/ 1107. It is outlining the Common Specifications (CS) for certain class D IVD medical devices (including SARS-CoV-2 tests) in the context of… Read More
The EU’s proposal for a new Artificial Intelligence (AI) act could upset the regulation and the supply of medical devices. The current proposal comes in addition to medical device legislation.… Read More
There certainly is a backlog in guidance especially related to the IVDR. In May, however, the Medical Device Coordination Group (MDCG) has issued a number of documents that may help… Read More
The Medical Device Coordination Group (MDCG) has published MDCG 2022-5, Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices. We highly recommend to… Read More
The Medical Device Coordination Group (MDCG) has recently issued guidance MDCG 2022-6, Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR. Article 110(3) of the… Read More
The medical supply chain in Ukraine has been severely thrown into disarray because of the Russian military invasion. One of their biggest problems is a shortage of medicines, medical devices… Read More
In January 2022, the European Commission has published five new standards harmonised under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) in the Official Journal of the EU… Read More
Harmonisation of standards under Regulation (EU) 2017/745 on medical devices (MDR) is further progressing. The table below shows the standards that have been published in the Official Journal of the… Read More
A 31-page guidance document, MDCG 2022-2 on the general concept of how to collect and sustain clinical evidence for in vitro diagnostic (IVD) medical devices under Regulation (EU) 2017/746 (IVDR)… Read More
The European Commission has published a new implementing regulation (EU) 2021/2026 outlining rules concerning the use of electronic instructions for use (elFU) in the context of Regulation (EU) 2017/745 on… Read More
It is now officially confirmed – Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) will see a progressive roll-out as previously proposed by the European Commission. This was… Read More
The European Association for Medical devices of Notified Bodies (TEAM-NB) are asking the European Commission to think again about a proposed regulation that could lead to repetition in regulatory requirements… Read More
One of the main concerns when planning towards compliance with Regulation (EU) 2017/745 on medical devices (MDR) is the clinical evaluation. According to article 61 of the MDR, manufacturers must… Read More
The Medical Device Coordination Group (MDCG) has issued a new guidance document “to provide further detail on the operational and practical implementation of Articles 13 and 14 and other related… Read More
The Medical Device Coordination Group (MDCG) has issued another guidance document, MDCG 2021-25. The document provides further guidance on certain open questions around how Regulation (EU) 2017/745 on medical devices… Read More
The European Commission has given in and makes concessions to the industry. On October 14, 2021 the Commission issued the corresponding proposal for a partial delay of Regulation (EU) 2017/746… Read More
The intended use statement of medical devices is a central aspect in the European regulatory environment. The intended use drives the requirements a device must fulfill. This has already been… Read More
The European Commission has put another item on its already long list of guidance documents for medical device manufacturers. MDCG 2021-24, Guidance on classification of medical devices, will probably be… Read More
Notified body bsi has published an article in February in the Journal of Medical Device Regulation. In this article, bsi is sharing insights on its perspective on how manufacturers should… Read More
Team-NB, the European Medical Devices Notified Body Association, published a position paper on the applicability of implant cards as required under Regulation (EU) 2017/745 on medical devices (MDR). Readers should… Read More
bsi announced that it started public consultation for BS AAMI 34971 Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning. The document is intended to provide… Read More
The date of application for Regulation (EU) 2017/746 on in vitro diagnostics (IVDR) is approaching quickly. As of May 26, 2022, all manufacturers of IVD medical devices will have to… Read More
The Federal Institute for Dugs and Medical Devices (BfArM) in Germany has issued a notice where it informs manufacturers and users about the inadequate sterilization of medical devices by Steril… Read More
EN 1041:2008 is the harmonized standard for information to be supplied by medical device manufacturers. The International Standardization Organization (ISO) has recently published ISO 20417:2021, which will replace EN 1041… Read More
The EU has approval to adopt and list standards that will be recognised under Regulations (EU) 2017/745 and 2017/746 on medical devices and in vitro diagnostic medical devices (MDR and… Read More
…for many manufacturers of products for general laboratory use like pipettes, centrifuges, thermocyclers or glass microscope slides. Some manufacturers are in the mistaken belief, that their device is regulated by… Read More
