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
Complete Link Section mdi Europa
Complete Download 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 more than 20 important… 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
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
The Regulatory Affairs Network That Keeps Your Business Safe
mdi Europa specializes on the services of an EU Authorized Representative*, but we also provide a worldwide network of highly experienced consultants and experts on regulatory affairs. Translations, market research,… Read More
Meet mdi Europa at Medica and Arab Health
Meet mdi Europa at Medica mdi Europa will attend Medica from November 18 to 20, 2019. Please contact us if you wish to schedule a meeting. Contact team mdi Europa… Read More
MDCG Guidance on MDD Certificates and SSCP under the MDR
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
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
New Guidance for the UK Responsible Person Published
The UK has updated its guidance on the UK Responsible Person. The document is applicable should the UK leave the EU without a deal and includes important details about the… Read More
Stop your Confusion about CE Marking – read our FAQ
What is CE Marking? Why do I need a European Authorized Representative? What is a Free Sales Certificate? Manufacturers, im- or exporters and distributors of medical devices find brief answers… Read More
Don’t Search No More, For Your EU Authorized Representative
Finding your EU Authorized Representative* is like finding the love of your life. Pity is, you already might have found the right one, but you just can’t believe your luck.… Read More
All About Brexit – But We’re Not Clairvoyant
Brexit or no Brexit? Deal or no deal? As long as the British Government is not in harmony with itself the story of “in or out” will keep the world… Read More
CE Marking Made Easy, Like a Day at the Beach
Of course, CE Marking is complicated. If you are a manufacturer, an im- or exporter or a distributor, your key competence probably centers more around engineering, sales or organizing endless… 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
United Kingdom (UK) to Request ‘UK Responsible Person’
Although there is less than 3 months to go until the Brexit date, conditions have not yet been agreed upon and it is likely that a no-deal will be reached. … Read More
A True Story about Trust and Guidance
If you raise a wonderful child – would you lay its destiny in the hands of someone who isn’t loyal? We wouldn’t! As a family owned business with a moving… 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