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
Latest MDCG Preparedness Plan and MDR Delay
Category: News in Brief
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
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
Brexit and the regulatory situation for the medtech industry
31 January 2020 was a somewhat significant day as the UK formally left the EU at a strategic point in the implementation of the Medical Devices and IVD Regulations (EU)… 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
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
Early access to Single Registration Numbers (SRN)
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
New MDR and IVDR checklists for PMS and Declaration of Conformity
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
News on symbols to be used under the MDR and IVDR
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
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
News on EUDAMED
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
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
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
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
News from the Commission – Notified Bodies and a Potential MDR Extension for Selected Devices
Many important documents and guidance for the implementation of Regulation (EU) 2017/745 on medical devices (MDR) are still missing. In certain aspects, however, things seem to evolve in a direction… Read More
European Commission Website on Regulations MDR / IVDR Restructured
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
New Checklist for Clinical Evaluations Available
mdi Europa has set up a checklist that is based on a formal template issued by the German competent authority. The template is used when reviewing the Technical Documentation, more… Read More
New Vigilance Reporting Templates and Supplementary Guidance on Vigilance Published
The European Commission has recently published a new reporting template for serious incidents under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices… 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
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
BfArM Recommendation on Paclitaxel-coated Stents and Balloons
BfArM, the German Federal Institute for Drugs and Medical Devices, recently published a warning notice for patients, users and manufacturers of stents and balloons that are coated with Paclitaxel. A… Read More
LRQA to Withdraw Notified Body Services
The UK Notified Body Lloyds Register (LRQA) announced that it will not apply for designation under the medical devices and IVD regulations (MDR and IVDR). The announcement comes at a… Read More
Quality Assurance Agreements (QAA)
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
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
Spain’s Only Notified Body Not Accepting Applications for Certification of New Products
Spain’s only Notified Body, based at the Spanish Agency of Medicines and Medical Products (AEMPS) regulatory agency, which is designated under the EU Medical Devices Directive (MDD) and In Vitro… Read More