Medical device manufacturers will have to become compliant with the new requirements of EU’s MDR and IVDR, which are expected to come into effect by end of May 2021 and May 2022 respectively. One of the key aspects of the new regulations is the implementation of a European Database on Medical Devices (EUDAMED) to assure the data and information needed on economic operators, product registration, quality certificates, declaration of conformity, clinical investigations, and post-market surveillance by all stakeholders (competent authorities, notified bodies, manufacturers, healthcare providers, and consumers) are easily accessible.
In the EUDAMED, only module 1 has come into force as of now. This provides manufacturers some time to prepare for the transition. Like any other regulatory changes, the transition will take time to get accustomed to and require transforming internal processes to meet the new requirements. For non-EU manufacturers, this will also require additional steps to submit the “Mandate Summary Document”.
After EUDAMED, anybody willing to do business in the EU will be impacted. This will include all actors – economic operator (EO) like manufacturers, system/procedure pack producers, authorized representatives, importers, and non-EU manufacturers selling their products in the EEA. The EUDAMED project is expensive for companies in terms of time and resources, and it’s particularly challenging in terms of IT resources. Many companies have underestimated the size and complexity of the required projects. At the same, time those countries (eg. India, South Korea, Japan) that import medical devices at large from the EU, will have to prepare themselves to incur a higher price of devices.
This whitepaper provides you with a roadmap for your EUDAMED registration.
