The pandemic-related extended transition period from MDD (Medical Device Directive) to MDR (Medical Device Regulation) is coming to an end.
You should have finally switched to MDR by 26 May 2021. I would like to briefly remind you that you need to take action.
Here are our top 5 from our current final spurt practice:
- Updating the classification according to MDR
- Updating the labelling (incl. instructions for use, based on UDI-DI)
- Updating technical documentation: design and manufacture
- Setting up a quality management system
- DIMDI/EUDAMED registration
The topics and order are not representative, but show that some topics have been postponed by market participants. Partly due to short-time working, partly due to other priorities.
Which topics may have been postponed and should be looked at again? The Medical Device Coordination Group (MDCG) has published 18 guidance documents in the past year alone, which eliminate many ambiguities in the interpretation of the requirements. These also include many suggestions and templates that simplify everyday regulatory work and can perhaps also dispel doubts about the quality of your own templates.
Use the last few weeks to complete your documentation and prepare for the new obligations under the PMS and PMCF. If you have any doubts or capacity bottlenecks, please do not hesitate to contact us. In many cases, we know a shortcut to the goal.
(1 Rating(s), average: 5.00 out of 5)
Loading...
