Work in progress: MDR implementation – impact on your Quality Management System (ISO 13485:2016)
- September 22, 2018
- Posted by: confinis
- Category: Regulations
Are you having a well-organized, structured and process-oriented QMS that meets the requirements of ISO 13485:2016 and the standards and directives relevant for your product portfolio?
If in addition you are living it in your organization – you can sit back and enjoy!
This basis will make entering the MDR era much easier and it will be more comfortable to implement the changes required for the new regulation.
Your active QMS according to ISO 13485:2016 and the additional relevant regulations will deliver a lot of data needed to fulfill the required output in the different reports you be obliged to initially and periodically prepare.
You have heard the following most probably already many times, but we can also only recommend to read the MDR, compare the new requirements with your processes, define the GAPs, evaluate suitable solutions, review and complete your processes. And yes, as always, you should plan on providing trainings for your employees regarding the changes in the processes and the handling of related documents. I believe in providing adequate templates to make the transition to MDR, or changes in general, easier for your colleagues.
Following key changes in the new MDR compared to MDD are affecting your QMS:
– QMS required, also for manufactures of class I medical devices
– Product scope expansion
– Implementation of unique device identification
– Rigorous post-market oversight
– Identification of person responsible for regulatory compliance
– Common specifications
– Reclassification of devices according to risk, contact duration and invasiveness
– More rigorous clinical evidence for class III and implantable medical devices
– Systematic clinical evaluation of class IIa and IIb medical devices
– No “grandfathering” provisions
– New technical documentation
The slides for you to download are intended to provide you with a rough overview over which articles of the MDR may affect which processes of your QMS. The presentation also shows the possible actions that may need to be performed for gaining compliance. The presentation does not purport to be complete and I also recommend to keep track of ongoing discussions and monitoring of publications.
Getting involved in discussions with your peers is a great way of elaborating feasible solutions. Needless to say, but I still do it: consider getting in contact with us to take advantage of the experiences we are constantly able to expand through our work. You’ll see more in our Services section.
by Karl-Heinz Spohn, Senior Consultant, confinis ag