EUDAMED launch postponed!
The new European regulations for the development, manufacture, marketing and surveillance of medical devices within the EU, in the form of the MDR und IVDR, require manufacturers to enter data relating to products and producers into the EUDAMED database. Industry experts see EUDAMED as a key element of the new regulatory framework, which is designed to improve market surveillance, ensure the exchange of information relating to clinical investigations and help ensure that the rules are applied consistently.
Under the original plan, manufacturers and other economic operators were to be required to enter their data into the EUDAMED database once the MDR takes effect, i.e. as of 26 May 2020. The MDR provides for an 18-month transitional period during which manufacturers are to collect all relevant data about their products (including those marketed under the MDD).
As of this week, we received confirmation of something that has long been evident and feared: EUDAMED's "go-live" date will be delayed by two full years.
The reason cited for postponement of the planned start date was the need for improvements to the database. Because of the planned improvements, the database cannot go online until the entire system and all its modules have attained full functionality and have been subjected to an independent audit, so that individual modules will not be activated separately. EUDAMED is now scheduled to launch for both medical devices and in-vitro medical devices on the date originally set for the IVDR, on 26 May 2022.
Impact of the delay on manufacturers
Despite its significance within the context of the rules established by the MDR, the postponement of EUDAMED's start date will have no impact on the effective date of the MDR itself. That Regulation is still slated to take effect on 26 May 2020 despite calls from companies to postpone the effective date. As a result, manufacturers would still be well-advised to ensure that their business and products comply with the MDR so that they will be prepared when the MDR takes effect and will be able to continue marketing their products. Registration in Germany will continue to be handled through the DIMDI database for the time being.