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
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Tag: Guidance Documents
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
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
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
Key guidance document on the classification of IVDs under the IVDR
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
Sufficient clinical evidence under the MDR for class I legacy devices
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
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
Guidance checklist for manufacturers of reusable and resterilizable medical devices
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
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
EU guidance on Notified Body clinical evaluation assessment reports
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
Clinical evaluation and equivalence – using literature under the MDR
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
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
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
Urgently Required MDR Guidance Documents for Clinical Evaluations and PMCF Published
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
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 and IVDR guidance updates
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
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
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
New guidance documents for EMDN and cybersecurity
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
MDCG guidance documents on MDR codes and sampling of MDR and IVDR devices published
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
Guidance document for class I device manufacturers
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
Performance Evaluation for IVD Medical Devices
Performance evaluations will take an integral part in the CE Marking process of in vitro diagnostic medical devices under the In Vitro Diagnostic Medical Devices Regulation (IVDR). This article outlines,… Read More
Guidance on Qualification and Classification of Software under the MDR and IVDR Published
The Medical Device Coordination Group (MDCG) has published a long awaited guidance document in October on the qualification and classification of software under Regulations (EU) 2017/745 and 2017/746 on medical… Read More
MDCG Guidance on MDD Certificates and SSCP under the MDR
Manufacturers of medical devices are eagerly waiting for more guidance on the implementation of the MDR. MDCG has now issued a useful guidance on the Summary of Safety and Clinical… Read More
Guidance on Person Responsible for Regulatory Compliance
The Medical Device Coordination Group (MDCG) has recently published a useful guidance on the “Person Responsible for Regulatory Compliance” (PRRC) according to article 15 of the MDR and IVDR. There… Read More
Guidance on Implant Cards
The Medical Device Coordination Group (MDCG) has recently published a useful guidance on the Implant Card (IC) according to article 18 of the MDR. It makes sense to review the… Read More
Unique Device Identification (UDI) and Regulations (EU) 2017/745 on Medical Devices and 2017/746 on In Vitro Diagnostics
The Medical Devices Coordination Group (MDCG) has published a number of guidance documents on the topic of UDI over the past months. More recently, the MDCG issued guiding principles for… Read More
EU Guidance on Quality Rules for Drug-Device Combinations
The long overdue guidance on quality expectations for regulatory filings in the EU concerning integral and other kinds of drug-device combination (DDC) is available in draft form for public consultation.… Read More
The World Health Organisation’s (WHO) New Draft Guideline
The WHO is looking for comment on its proposal to combine the features of good storage and distribution for medical products into a single guidance document and will be applicable… Read More