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: IVDR
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
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
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
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
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
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
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
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
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
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
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
Guidance on legacy devices regarding Eudamed
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
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
IVD or not IVD? That is the question…
…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
Updated EUDAMED implementation dates
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
MDCG guidance on administrative practices and technical alternatives until EUDAMED full functionality
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
Voluntary registration with EUDAMED database – industry fears duplicate registrations
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
EU IVD medical devices sector destined for crisis?
The European Commission has fallen behind when it comes to providing guidance and structures required to support the in vitro medical devices sector in timely compliance with Regulation (EU) 2017/746… Read More
New website on actor registration in EUDAMED 3 available
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
Practical advice for setting up an MDR and IVDR compliant PMS Plan
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
Get ready for the economic operator registration in EUDAMED
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
EUDAMED economic operator registration module available as of December 2020
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
New guidance document shows how to use MDSAP audit reports for MDR/ IVDR surveillance audits
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
Updated Q&A document on MDR and IVDR UDI requirements from the European Commission
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
New MDR and IVDR guidance documents published by MDCG and MedTech Europe
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