The one-year postponement of DoA for MDR was a necessary move by the Commission. Notified Bodies have also during this extra year opened up again for possible renewal of existing EC certificate according to MDD.
During the spring and summer, over 20 new and revised guidance documents related to the new Regulations have been published by the Commission. Some are useful, such as the Clinical evaluation assessment report template and some provide less guidance than wished for.
The industry is awaiting publication of key IVDR guidance documents, for example on the classification of IVD which is fundamental for manufacturers in some cases to choose and plan a correct conformity route for CE marking. The MDCG IVD group has instead been forced this spring to put a lot of effort into addressing issues and regulatory questions related to COVID-19 IVD tests.
Currently only four Notified Bodies for IVDR are listed in the NANDO database to take on the huge industry demand. Lobbying activities against the Commission by industry organizations are ongoing for a postponement of IVDR. QAdvis take active part in these activities. It would be desired but there are no official signs at all at the moment from the Commission and there is an obvious risk for manufacturers to just wait and see.
Autumn 2020 is a lot about to manage the gray. Despite not having all the answers, decisions still have to made. QAdvis can support with this by preparing or creating the regulatory documents needed for MDR and IVDR based on the best currently available information and draft to-be-published guidance documents. We can also help to pre-assess the Technical Documentation in a Notified Body style manner, to minimize any negative surprises later on.
We also offer the service to take on the PRRC role for manufacturers that would like this to be managed by a trained and experienced regulatory professional.
To help you prepare for the implementation or get started with IVDR, we have a recently published a whitepaper
QAdvis Academy provides both open courses and seminars and customer site specific training events.
Read more about our courses and seminars here.
QAdvis Academy provides open courses and seminars as well as customer site specific training.
The course fee for our MDR and IVDR online courses includes one hour follow up session explicit to each participant for questions and discussions with one of our senior consultants.
We also cooperate on trainings with both Swedish Medtech and Intertek Academy.
TD-documentation – online
The course is arranged by Swedish Medtech in co-operation with QAdvis.
For reservation see Swedish Medtech´s kursinformationssida.
IVDR and MDR – online
Courses intended for quality and regulatory professionals working with medical devices and in vitro diagnostic medical devices, as well as company management and other employees who needs to learn more about the impact and get a basic understanding of MDR and IVDR.
The aim is to give participants a basic understanding and useful tools when implementing MDR and IVDR.