Has the penny dropped?

Staggering of transition periods for the regulation on in vitro diagnostic medical devices As already sufficiently known, the IVDR 2017/746 will replace Directive 98/79/EC (IVDD) on 26.05.2022 according to the current plan. Now, on 14.10.2021, news reached us that will probably relieve many manufacturers of medical devices, but also other economic actors, users and patients. Together with the MDCG, DG…

How to hook as little as possible

The Act on the Implementation of EU Regulations Concerning Medical Devices (Medizinprodukterecht-Durchführungsgesetz - MPDG) has formally entered into force on May 26, 2021, and has replaced the former Medical Devices Act (Medizinproduktegesetz MPG) - at least for medical devices that are not in vitro diagnostics. But how will the national innovations play out in practice? And what do manufacturers need…

Way out of the MDR standards jungle

In March of this year, we had already reported on the European Commission's "standardization request", which allows initial conclusions to be drawn about the standards that will presumably soon be harmonized under the MDR. In July, things actually got underway. Current status of harmonization in Europe On July 16, a first implementing decision on the harmonized standards for the MDR…

Clinical trial: Not always, but more and more often!

As part of the introduction of the MDR (Medical Device Regulation), the Medical Device Coordination Group (MDCG) regularly publishes recommendations which, based on the MEDDEV documents used to date, represent recommendations for action in dealing with the implementation of the requirements of the MDR. In particular, the area of clinical trials for medical devices places high demands on sponsors within…

A steady hand and calm reflection

MDR and the national legislation The Medical Device Adaptation Act (MPEUAnpG) to repeal the national implementation of Directives 90/385/EEC, 93/42/EEC and 98/79/EC was already one year old in May 2021. We have already informed you about the contents of the MPEUAnpG and the new Medical Devices Implementation Act (MPDG) that emerged from it. But how does the national legislation look…

When the certification process drags…

Ready for MDR - Waiting for May 26, 2021. Are you on the safe side when everyone else panics shortly before May 26, 2021? Then we assume that you have prepared yourself and your company thoroughly: You've conducted MDR training. The plan for the MDR transition is in place. The processes for approval procedures, labeling, post-market surveillance (PMS) and reporting…

Clinical trial – forethought instead of hindsight

A clinical trial of medical devices is not always a necessary component in the approval process, which includes several phases. In most cases, these trials are time-consuming and costly, because the regulatory requirements for a clinical trial are extensive and complex. This article shows which phases a clinical trial goes through and what needs to be paid special attention to.…