What effects do the extended MDR deadlines have on the registration of medical devices?
The European Commission and Member State representatives recently announced a change to the MDR registration deadlines: The revised deadline for the registration of medical devices (including legacy devices) in EUDAMED is now November 2021 and no longer May 2020, but it should be noted that products must be registered before a manufacturer can submit an MIR (Manufacturer Incident Report) in EUDAMED.
In order to avoid duplicate processes within a company - such as tracking which devices have already been registered in EUDAMED and which have not - it is recommended to start registering all products as soon as possible. This is particularly important in order to comply with MDR requirements as quickly as possible in the event of an incident. In exchange with our customers, we are being informed that, as a rule, we would like to register all products in EUDAMED as soon as possible and no later than 2020.
atrify is confident to soon complete the M2M test process of the EUDAMED Connector with the EU Commission. We will help all medical device manufacturers to adapt their product content to MDR requirements as early as 2019 and to register their products with EUDAMED from March 2020.
To provide manufacturers with a comprehensive solution that fully complies with EUDAMED requirements and to simplify the handling of manufacturer incident reports, we will offer the upload of documents to EUDAMED, e.g. for manufacturer incident reports.
Our experts can help you assess your EUDAMED readiness and support you in evaluating and testing EUDAMED data models. Please contact us at info@atrify.com.
Find out more about our EUDAMED solution.
