When discussing upgrading the company’s quality system and technical documentation to meet the EU-MDR requirements, many of the companies still think that this is "an activity that QA&RA department should deal with".
However, the truth is that the main failure cause or bottleneck for upgrading to EU-MDR is the activity related to design and development.
For example, product verification and validation tests that have not been performed, design and development documentation that was not kept up-to-date (specifications, drawings etc.), product risk management plans and reports, design changes that were not analyzed and implemented properly and/or were not followed by the relevant verification and/or validation tests, customer complaints that were not analyzed properly as far as influence on product performance and safety is concerned, clinical evaluation documentation including postmarking clinical follow-up and in some cases also the need for clinical trials.
These activities take time, usually, months or even years.
Many of these requirements were already there in the MDD, but they were not enforced by the NBs to the extent that they are enforced under the EU-MDR.
If the company does not have significant support from the design and development team, the QA&RA departments will not be able to successfully lead the effort to meet the requirements of the EU-MDR.
The issues described in relation to design and development, are also critical for successful FDA inspections, which have significantly increased over the last year.
It is very important to recognize this fact and understand what needs to be done to achieve compliance.
If you recognize a risk in one of your systems in one of the different parts of the life cycle, please don’t hesitate to contact us; we would be happy to help you.
This article was prepared by:
Marina Lebel B.Sc., CQE
VP, Medical Device
