The Federal Institute for Dugs and Medical Devices (BfArM) in Germany has issued a notice where it informs manufacturers and users about the inadequate sterilization of medical devices by Steril… 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
…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 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
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
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
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
With 67 million inhabitants, France is the second largest market in Europe after Germany. And this also applies to the Medical Device sector. Therefore, medical device manufacturers from all over… 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
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
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 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
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 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
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
On December 17, 2019, the final vote for the second corrigendum to the Medical Devices Regulation (2017/745, MDR) took place. It is now officially confirmed that some class I medical… Read More
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
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
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
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
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
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
The European Commission’s Medical Devices Coordination Group (MDCG) recently published two guidance documents on timelines for device registration and on registration expectations for manufacturers of legacy devices. Legacy devices in… Read More
Don’t worry about changing your EU Authorized Representative! The process became much more formal, but not complicated. We guide you through. Change process under the MDR / IVDR Under the… Read More
