The EU Medical Device Regulation 2017/745
What is the EU Medical Device Regulation?
The new European Medical Device Regulation came into force in May 2017 with the aim of ensuring patient care with safe medical devices. The MDR primarily provides for increased requirements for the placing on the market and monitoring of medical devices in the European Union. In addition, it also defines a number of requirements for manufacturers, authorised representatives, importers and distributors of medical devices, some of which are new.
When will the new MDR come into force?
After the date of application was postponed by one year due to the Covid-19 pandemic, it is now imminent. On 26 May 2021, the MDR will replace the previously valid Medical Device Directive 93/42/EEC. However, products that were still produced in accordance with MDD 93/42/EEC can continue to be used as long as the expiry date has not been exceeded.
What impact does the MDR have on WERO products?
WERO reacted at an early stage and has already adapted its medical devices to the requirements of the MDR. We therefore continue to support our customers from industry, trade and administration with our comprehensive range of services as well as high-quality and MDR-compliant products.
