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
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
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 section below is intended for all parties who are involved in the manufacturing of medical devices including in vitro diagnostic medical devices. You will find more than 50 important… 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 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
Back in August, we have issued an article about a new guidance document published by the Medical Device Coordination Group (MDCG), MDCG 2021-21. The guidance document lays out specific requirements… Read More
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
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 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
…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
The European Commission has published a key guidance document on the classification of in vitro diagnostic medical device (IVD) under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)… 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 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 has issued a document that is highly relevant for manufacturers of reusable and resterilizable medical devices. You can find this document here. The background for issuing this… 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
The European Commission’s Medical Devices Coordination Group (MDCG) has issued a guidance document outlining the role of the Notified Body’s clinical evaluation assessment report (CEAR) in assessing a device under… 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 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
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
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
The European Commission has officially recommended to postpone Regulation (EU) 2017/745 on medical devices (MDR) for one year. All eyes are on the EU institutions if the proposal will be… Read More
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
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
The European Commission has issued new guidance documents on the new nomenclature system EMDN that manufacturers must use under the Medical Devices and IVD Medical Devices Regulation (EU) 2017/745 and… Read More
The Medical Device Coordination Group (MDCG) issued two additional guidance documents in December 2019. The “Explanatory notes on MDR codes” provide further clarification on the use of designation codes of… Read More
The Medical Device Coordination Group (MDCG) issued a guidance document to help manufacturers of class I medical devices to comply with Regulation (EU) 2017/745 on medical devices (MDR). It gives… Read More
