EUDAMED is the database developed by the European Commission for the registration of economic operators and their medical devices.
The economic operators manufacturers, importers and EU-REPs have had to register in EUDAMED since last year. Products can currently only be registered by notified bodies .
In Germany, registration in EUDAMED is the responsibility of the relevant state authorities. As part of the registration process, mandates must be issued in some cases and proof of qualifications must be provided. These company registrations and the associated allocation of the SRN (Single Registration Number) now also take place more or less quickly following a successful examination.
Another effect that we are observing is the auditing of economic operators by the state authorities. These audits also include a review of the technical documentation and pending process descriptions. According to our observations, the authorities are very thorough in this respect. They take the time to study documents such as the clinical evaluation according to MDR , or risk management files according to EN ISO 14971 in detail and, if necessary, take them apart.
It is advisable to ensure that your own Regulatory Affairs Manager is present during the audit. Many deviations can certainly be avoided with explanations from the experts.
The regulatory employees are generally very interested in constructive cooperation. However, this constructive cooperation must not be misunderstood as an opportunity to "cheat". The audits are conducted at a high professional level and MDR requirements need to be implemented.
Take the time to check and update your documentation. Observe any new deadlines for notifications and updates, as well as new procedures that are described in this form for the first time in the MDR.
If you have any questions about registration, please contact us. We are happy to help!
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