What are Common Specifications under EU MDR & IVDR?
What are Common Specifications? Is this the same as ISO standards or any other guidance? This is what we will review within this episode with Stefan Bolleininger. In the EU MDR and IVDR, Common Specification is mentioned and it is a tool that the EU Commission can use.
But are you obliged to use them? In this episode, we will talk about a few common specifications. 1 published, 1 under draft, and some that are supposedly planned.
And we can see also that some of the provisions of the EU MDR cannot be applied without the publication of some common specifications.
So even if you think you are not impacted by Common Specification, you maybe need to re-evaluate that after listening to this episode.
Who is Stefan Bolleininger?
Stefan Bolleininger is a key opinion leader and speaker for the medical device regulation MDR in Europe.
He founded the be-on-Quality GmbH consulting agency to passionately support manufacturers during CE approvals or FDA approvals. This support covers the full chain of quality and regulatory requirements: Implementation, maintenance, audits, assessments, and inspections.
In the area of “Risk Management and Usability for Medical Devices and Medical Networks”, he holds a teaching assignment at the Technical University of Nuremberg and the VDI Technical Committee “Quality Assurance for Software in Medical Devices”.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.
After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world.
He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…
- Stefan Bolleininger LinkedIn: https://www.linkedin.com/in/stefan-bolleininger-3a717028/
- Be-on-Quality website: http://www.be-on-quality.com/
- Common Specifications 2020/1207: https://eur-lex.europa.eu/eli/reg_impl/2020/1207/oj
- Annex XVI Live session: https://youtu.be/kpIphE2PVew