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 40 important… Read More
Complete Download Section mdi Europa
Complete Link Section mdi Europa
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 an up to date… Read More
Certificates of Free Sale
We can help you to enter different markets worldwide – with Free Sales Certificates for your medical device or In vitro diagnostic products! Many countries outside of the European Union… Read More
Guest article: Devices without an intended medical purpose under the MDR
Regulation (EU) 2017/745 on medical devices (MDR) introduces annex XVI to add provisions for devices without an intended medical purpose. What was the reason for their inclusion? Products like decorative… Read More
Updated timetable for Eudamed
On its website on the European database on medical devices (EUDAMED), the European Commission has declared a new timetable for the new Eudamed medical device database. According to the Commission,… 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
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
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
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 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
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
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
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
Second MDR corrigendum published
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
Supportive Information Section mdi Europa
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
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
News on Brexit
What many may already have expected has now been confirmed. UK Prime Minister Boris Johnson has been forced by the House of Commons to request another delay of Brexit date… 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