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
Below we listed a collection of useful documents to support your compliance process. These have been compiled by or on behalf of mdi Europa and are thus not available free… Read More
The European Commission wants to permit early access to SRN before Eudamed launches in 2022 Eudamed will be delayed by at least two years. However, upon pressure by local country… Read More
During the past years, mdi Europa has provided a number of templates and checklists that may be useful for the transition of the Medical Devices Regulation and In Vitro Diagnostic… Read More
MedTech Europe has published an article earlier this year about symbols that have been proposed by the industry association to be included in the new revision of ISO 15223-1. MedTech… Read More
The requirements under the Medical Devices Directive and In Vitro Diagnostic Medical Devices Directive (93/42/EEC, MDD and 98/79/EC, IVDD) for the set-up of technical files were very general in nature.… 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
The European Commission is continuing efforts to designate additional Notified Bodies under the new Regulations. More recently, bsi Netherlands and DARE!! Services have both been designated under Regulation (EU) 2017/745… 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
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
MedTech industry is desperately waiting for more Notified Bodies to be designated under the MDR and IVDR. Two more organizations have now been appointed. You may already have heard the… 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 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 20 important… Read More
You are a medical device manufacturer and have CE marked your products under the In Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDD)? Then you must transition to the IVDR in the… 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 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
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
Only several months before the Regulation (EU) 2017/745 on medical devices (MDR) fully applies it is time for positive aspects: The MDR contains constructive guidance in many crucial aspects, one… Read More
It seems that the medtech system is on course for calamity because NB designation under the new EU Regulations 2017/745 and 2017/ 746 on medical devices and in vitro diagnostic… Read More
Notified Bodies have a crucial role in the CE Marking process. Below you will find an overview of the role of Notified Bodies and what is important when selecting and changing… Read More
