The MDRs comes into force in May 2021. I suggest to pay focus to the following areas in particular:
- Will your Notified Body remain active in your therapy area when the MDR comes into force? If not, it is time to engage with a notified body that does.
- If you are a manufacturer of In-Vitro Diagnostic Medical Devices (IVD) you might have a change of classification to a higher risk class in your product portfolio which requires a re-certification of the products.
- Is the distributors and importers of your devices made aware of their responsibility, and are they controlled according to the requirements in MDR (17/745) Article 14?
Contact me if you need more information, or would like a gap-analysis of you current products and quality system in relation to the MDRs.