The document addresses a crucial issue, often confusing for manufacturers, authorized representatives, importers and distributors, the applicability of MDR requirements to legacy devices and ‘old’ devices.
Check out it here: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2021_25_en.pdf
If you are a US manufacturer and need help with the EU Market, do not hesitate in contacting us for being your Authorized Representative in the European market. We work with medical devices, cosmetics and nutraceuticals products. Also, if you need Regulatory advice, documents review, or importation services, do not hesitate in contact us! We will match any quotation you bring us and give you 100% off the competitor´s rate.
Comments