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
IVD medical devices after the IVDR date of application
Tag: European Commission
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
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
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
Extended IVDR transition period for certain IVD medical devices
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
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
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 clearance for MDR and IVDR harmonised standards
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
EU – Switzerland MRA expired
The European Commission issued an article that announces the expiration of the EU-Switzerland Mutual Recognition Agreement (MRA). The article says: “The Mutual Recognition Agreement (MRA) is one of the key… Read More
New guidance documents published by the European Commission
The date of application of Regulation (EU) 2017/745 on medical devices (MDR) is approaching and the European Commission has issued new and updated guidance documents. Please find below a list… Read More
Commission to put forward another European standards request
The European Commission’s “State of play of joint Implementation plan on actions considered necessary to ensure the sound functioning of the new framework for medical devices under the MDR”, which… Read More
Relocation of the European Commission website on medical devices
In summer 2019, mdi Europa has reported that the European Commission has restructured its website on medical devices. Since then, manufacturers could retrieve valuable information about EU regulatory requirements under… Read More
European Commission’s device standardisation request rejected
The formal standardisation request from the European Commission to the European standards bodies will get essential standards work to support compliance with Regulation (EU) 2017/745 on medical devices (MDR). The… Read More
Updated timetable for Eudamed
On its website on the European database on medical devices (EUDAMED), the European Commission has declared a new timetable for the new Eudamed medical device database. According to the Commission,… Read More
Surgical and FFP masks in the COVID-19 crisis
The German Federal Institute for Drugs and Medical Devices (BfArM) has specified on its website the provisions for this special route, which follows Recommendation (EU) 2020/403 from March 13. The article… Read More
MDR Postponed by One Year!
What has been proposed by the European Commission and confirmed by the European Parliament has been signed off by the European Council. As a consequence, the delay of Regulation (EU)… Read More
European Commission gives details of how to prevent COVID-19 test failures
The European Commission has published a derogatory report on the level of evidence available for COVID-19 tests – RNA, antigen and antibody tests – arriving on the market. It explains… Read More
MDR Postponement – Handle with Care!
The proposal for a one-year delay of Regulation (EU) 2017/745 on medical devices (MDR) that was proposed the European Commission has been confirmed by the European Parliament. The last step… Read More
Guidance on MD and PPE in times of COVID-19 and local provisions
The European Commission has continued to work on guidance for manufacturers and other economic operators of medical devices and personal protective equipment (PPE) to provide answers on specific questions that… Read More
Latest MDCG Preparedness Plan and MDR Delay
The European Commission proposed a delay of the MDR and suggested to postpone the date of application for one year due to the current COVID-19 crisis. The Joint Implementation/Preparedness Plan… Read More
European Commission Recommendation on Regulatory Exemptions for COVID-19 Products
The European Commission proposed to exempt certain medical devices and personal protective equipment (PPE) urgently required in the current COVID-19 crisis from regular CE marking requirements. Germany and the UK… Read More
News on EUDAMED
From different sources we have heard that the introduction of EUDAMED will be delayed – probably for two years. In the meantime, this has been confirmed on the European Commission’s… Read More
European Commission Website on Regulations MDR / IVDR Restructured
The European Commission has restructured and further developed its website on the Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR). We strongly… Read More
New Vigilance Reporting Templates and Supplementary Guidance on Vigilance Published
The European Commission has recently published a new reporting template for serious incidents under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices… Read More