All medical devices placed on the EU marketplace after May 2020 will need to be compliant to the Medical Device Regulations (MDR) or the In Vitro Diagnostics Regulations (IVDR). Compliance with the Medical Device Directives will no longer be acceptable.
The new requirements will ensure that product safety is taken more seriously. We can help you to update your technical files to be compliant to the MDR or IVDR, making sure that you meet all the new or additional technical requirements stated in regulations EU 2017/745 and EU 2017/746.
If you would like to know about this service, then please contact us. At Patient Guard, our team of specialists make it our business to keep on top of regulatory changes. If you are unsure about what is required for compliance, one of our medical device regulatory consultants can arrange to perform a Gap Analysis of your technical files. This will provide you with a clear regulatory pathway on how to proceed.