The COVID-19 (coronavirus) outbreak has put a halt to many aspects of everyday life around the world. As infection rates and the death toll mount, people are staying indoors and businesses are being shuttered. Governments are hastening to limit the impact of the outbreak, including a new proposal to push back the deadline for the European Union (EU) Medical Device Regulation (MDR).
The regulation, which replaces the older EU Medical Devices Directive (MDD), would have require companies to recertify some existing medical devices and certify new products entering the market by May 26, 2020. The certification process is complex, requiring comprehensive technical files and large volumes of substance data.
With companies and governments putting their full efforts into containing COVID-19, few have the resources to spare to meet the incoming requirements of the regulation (both submitting technical files and approving them). The European Commission has requested that the date be postponed by one year, to allow both companies and governments to gain control of the coronavirus crisis. The proposal still needs to be ratified by the commission and passed by European Parliament.
The European Commission has said they will push to have the proposal formally submitted to parliament in early April, where they hope it will be quickly approved.
If the deadline is accepted, companies will have an additional year to acquire substance data and prepare their technical files. However, the process is time consuming and labor intensive. Companies are recommended to start the certification process as soon as they are able to ensure they meet the new deadline requirements and can maintain market access.
Assent Compliance is the industry-leading supply chain data management solution, enabling efficient and effective collection, validation and management of data related to product compliance regulations such as the EU MDR. To learn more about how Assent can help, contact us today.