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 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
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
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 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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, 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
Despite warnings about hold-ups at Notified Bodies and products failing to be certified under the new Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation (EU)… Read More
The WHO is looking for comment on its proposal to combine the features of good storage and distribution for medical products into a single guidance document and will be applicable… 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
