Preparing for unannounced EU regulatory inspections – are you ready?
This article was originally published in Clinica
Unannounced visits from notified bodies are going to be part of life for medtech manufacturers in the EU. But do you know how you would cope if two inspectors walked through the door, expected your staff to host the visit and your testing equipment to be dedicated for their immediate use? Do you know what costs you would have to bear? Here, Gert Bos* and Francoise Schlemmer* of notified body association TEAM-NB explain why it is critical that manufacturers and subcontractors practice and validate protocols for hosting such visits
You may also be interested in...
The European Commission has updated its rolling plan. It now looks as if current member state rules for non-medical products could persist beyond the 26 May 2021 deadline.
A formal notice ends the debate over the legality of making modules of the new Eudamed 3 medical device database available as soon as they are ready.
Notified bodies should now be regulated centrally in Europe rather than by individual EU member states. That is the view of one of Europe’s most experienced notified body experts.