The European Commission has published new timelines related to EUDAMED. The Commission expects EUDAMED to be fully functional in Q2 of 2023. The corresponding publication in the Official Journal of… Read More
EUDAMED update on timelines
Category: News in Brief
Ukraine tries to maintain business as usual
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
New cybersecurity standard
The requirements of the cybersecurity standard for medical devices, which was published a short time ago, surpasses what regulators are now looking for from medical device manufacturers. The new standard… Read More
IVD medical devices after the IVDR date of application
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) will become fully applicable on May 26, 2022. In this context, we would like to draw the reader’s attention to… Read More
New guidance for notified bodies of MDD/ AIMDD legacy device certificates and IVDR class D devices
The European Commission has issued new guidance documents that concern the activities of notified bodies under Regulations (EU) 2017/745 and 2017/746 (MDR and IVDR). MDCG 2022-3 provides clarification on verification… Read More
EN ISO 13485 and symbols standards harmonised under the EU’s IVDR
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
MDR harmonised standards update
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
New guidance for third-country manufacturers of COVID-19 IVD tests
The European Commission attempts to further clarify its expectations on IVD medical devices related to SARS-CoV-2 and its manufacturers. In January 2022, the Medical Device Coordination Group (MDCG) published MDCG… Read More
IVDR clinical evidence
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
elFU rules under the EU‘s MDR
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
European Commission proposal for progressive roll-out of the IVDR adopted
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
New artificial intelligence regulations could lead to unnecessary burdens
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
bsi white paper on clinical evaluations
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
MDCG guidance document on distributors and importers published
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
European Commission EUDAMED website expanded
In earlier newsletter issues, we reported that additional EUDAMED modules were made available. In parallel, the European Commission expanded the website and associated subject areas with tabs for each module.… Read More
Consultation on amending UK medical devices regulations
Although Regulations (EU) 2017/745 and 2017/746 on medical devices and in vitro diagnostic medical devices (MDR and IVDR) are in operation in the EU, medical devices legislation in Great Britain… Read More
The MDR is now fully applicable – but it means not the end of the world
Regulation (EU) 2017/745 on medical devices (MDR) is fully applicable since May 26, 2021. The MDR is considered a game changer for the medical device industry. The bad news is,… Read More
New guidance on legacy devices published
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
IEC about to publish new standard on cybersecurity
The International Electrotechnical Commission (IEC) plans to issue the new cybersecurity standard IEC 81001-5-1 soon. It deals with how IT security must be considered in the software life cycle. As… Read More
Free intended use generator – an important tool under the MDR and IVDR
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
New European Commission guidance document on MDR medical device classification
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
EUDAMED UDI/Devices and NBs/Certificates modules now live
The European Commission has announced recently that the EUDAMED UDI/Devices and NBs and Certificates modules are now ready. Specifically, the UDI/Devices module is probably of interest for many manufacturers as… Read More
MDCG 2019-6, rev. 3 lays out provisions for notified body pre-certification services
Back in 2019, the Medical Device Coordination Group (MDCG) published guidance MDCG 2019-6, a Q&A document related to requirements around notified bodies. The Commission has now issued revision 3 of… Read More
bsi article on clinical evaluation requirements under the MDR
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
The European Commission publishes important guidance on the requirements for COVID-19 tests under the IVDD
The Medical Device Coordination Group (MDCG) has published guidance MDCG 2021-21 “Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices” – the document is critical for all manufacturers… Read More
Team-NB publishes position paper on the applicability of MDR implant card requirements
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 develops guidelines for the application of ISO 14971 to artificial intelligence and machine learning
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 IVDR and performance evaluation studies
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
New MDCG guidance document maps IMDRF UDI principles with MDR and IVDR
The Medical Device Coordination Group (MDCG) has issued another guidance document. MDCG 2021-10 references certain principles and terminology used in appendices E – I of the IMDRF N48 guidance document… Read More
Insufficient sterilization of medical devices by Steril Milano S.r.l
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
Guidance documents on clinical investigation applications, UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers, implant cards and EMDN
The Medical Device Coordination Group (MDCG) has issued new guidance documents under Regulation (EU) 2017/745 on medical devices (MDR): MDCG 2021-08 lays out application mechanisms including application forms for clinical… Read More
EU UDI helpdesk available
Just recently, the European Commission launched a new helpdesk website for EU UDI related questions under Regulations (EU) 2017/745 and 2017/746 on medical devices and in vitro diagnostic medical devices… Read More
Standard ISO 20417:2021 for the MDR and IVDR published
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