Are you ready for the implementation of the new Medical Device Regulations (MDR) on 26th May 2021 or for the new In Vitro-Diagnostic Regulations (IVDR) on the 26th May 2022?
Are you exporting to EU and looking for an Authorised Representative?
Make sure you comply with all regulatory requirements with Medilink’s Regulatory service.
Whether it’s determining how your product is likely to be regulated, a one-day gap analysis day with a clear output of prioritisation of work and a plan to move forward, a clinical evaluation report, regulatory submissions or other bespoke requirements, our team is ready to help.
Please contact [email protected] to discuss how we can help you.