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
All posts by Michael Sander
BfArM informs about damages to hip implants
BfArM informs about damages to hip implants caused by high-frequency cauterizing instruments BfArM, the German Federal Institute for Drugs and Medical Devices, has issued a recommendation in connection with high-frequency… 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
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
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
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
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
Commission to put forward another European standards request
The European Commission’s “State of play of joint Implementation plan on actions considered necessary to ensure the sound functioning of the new framework for medical devices under the MDR”, which… 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
ISO TR 20416 and PMS under the MDR
According to article 84 and annex III of Regulation (EU) 2017/745 on medical devices (MDR), manufacturers must draw up a Post-Market Surveillance (PMS) Plan. As mentioned in previous articles, PMS… 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
European Commission’s device standardisation request rejected
The formal standardisation request from the European Commission to the European standards bodies will get essential standards work to support compliance with Regulation (EU) 2017/745 on medical devices (MDR). The… 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
Medical Device Distribution in France
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
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
MDR Postponed by One Year!
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
MDR Postponement – Handle with Care!
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
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
Latest MDCG Preparedness Plan and MDR Delay
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
Usability and the MDR
Regulation (EU) 2017/745 on medical devices (MDR) requires manufacturers to fulfill much more specific obligations with regards to usability. It is important to note that these requirements are applicable for… Read More
Update on Notified Bodies
Regulation (EU) 2017/745 on medical devices (MDR) is not even three months away and the designation of Notified Bodies is still behind the expectations of the industry and the announcements… 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
Latest version of ISO 14971 on risk management and the MDR and IVDR
ISO 14971 is a global risk management standard that has just been updated in keeping with technological and regulatory changes in the medtech industry. In the EU, the standard is… 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
Technical Documentation format under the MDR and IVDR
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
DARE!! Services, bsi Netherlands and bsi UK designated under the MDR and IVDR
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 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
New Notified Bodies Designated under the MDR and IVDR
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
BfArM Informs about Insufficient Labeling of Speaking Valves
BfArM, the German Federal Institute for Drugs and Medical Devices, was informed that accessories for patients treated in tracheostomy procedures are currently insufficiently described in normative terms. The German Standardization… Read More
Recommendation of BfArM regarding Breathing Hoses in Anesthesia
BfArM, the German Federal Institute for Drugs and Medical Devices, has become aware of risk reports in which patients have been harmed as part of anesthesia induction. Risk of Possible… Read More
Most Important Changes – Regulation (EU) 2017/745 on Medical Devices (MDR)
You are a medical device manufacturer and have CE marked your products under the Medical Devices Directive 93/42/EEC (MDD) or the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD)? Then you must transition… Read More
Most Important Changes – Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR)
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