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 50 important… Read More
Complete Download Section mdi Europa
All posts by mdi Europa
The MDR is now fully applicable – but it means not the end of the world
Regulation (EU) 2017/745 on medical devices (MDR) is fully applicable since May 26, 2021. The MDR is considered a game changer for the medical device industry. The bad news is,… 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
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
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
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
The World Health Organisation’s (WHO) New Draft Guideline
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
Swiss Medical Device Manufacturers Under Pressure
There is continuing doubt about the outcome of the Institutional Agreement (InstA) Switzerland negotiated with the EU. Hence, the advice from Switzerland’s Medtech industry association is to begin considering preparing… Read More
Draft Policy on Remaining Shelf-Life for Medical Products
The World Health Organisation (WHO) was looking for feedback from stakeholders on a draft policy which gives details of how medical devices, diagnostics and other medical products should be managed… Read More