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
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
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
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
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
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
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
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
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
Legacy devices are products that have been CE marked in the context of the current Directives but not under Regulations (EU) 2017/745 and 2017/746 on medical devices or in vitro… Read More
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
The European Commission has updated the planned implementation timelines for the gradual introduction of the corresponding modules. The actor registration module went live on December 1, 2020. Until the more… Read More
The Medical Device Coordination Group (MDCG) has issued a new guidance document MDCG 2021-1, Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional. The document… Read More
The first module of the EU medical device database, EUDAMED, is up and running. However, because actor registration is voluntary until 26 May 2022, when the complete database is planned… Read More
Under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), EU Authorized Representatives are – among others – in charge of… Read More
This article discusses the major aspects covered by the guidance document MDCG 2020-6, Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC, herein referred to… Read More
In August 2020, the Medical Device Coordination Group (MDCG) announced that the economic operator registration or actor registration module will be available as of December 1, 2020. This module will serve… Read More
Till date, neither the European Commission nor a related organization has issued an official guidance document on the medical devices regulation (MDR) and in vitro diagnostic medical devices regulation (IVDR)… Read More
In a recent article we have reported that the EUDAMED economic operator registration module will be available as of December 2020. The corresponding registration will trigger the assignment of a… Read More
Last year, the European Commission has announced that EUDAMED 3 as one central aspect for the implementation of important medical devices regulation (MDR) and IVD regulation (IVDR) mechanisms, will not… Read More
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
The Medical Device Coordination Group (MDCG) has issued a guidance document that is intended to streamline audit processes and efforts under the medical devices regulation (MDR) and IVD regulation (IVDR).… Read More
The European Commission has updated its Q&A document on UDI requirements under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). The paper provides answers to… Read More
According to article 84 and annex III of Regulation (EU) 2017/745 on medical devices (MDR), manufacturers must draw up a Post-Market Surveillance (PMS) Plan. As mentioned in previous articles, PMS… Read More
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
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
Using literature for clinical evaluations was a common approach for setting up clinical evaluations under the MDD. This article discusses the new MDCG 2020-5 guidance document, which illustrates to what… Read More
mdi Europa is constantly screening various sources on news and guidance that could be of importance for medical device manufacturers. In this context, we came across two guidance documents that… Read More
The European Commission seemingly wants to catch up with the shortfalls of the last years. Late April, the following guidance documents for Regulation (EU) 2017/745 on medical devices (MDR) have… Read More
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
