Article:

Agreement Annex Eudamed: What You Need to Know

On May 27, 2021, the European Union released the final version of the agreement annex for the European Database on Medical Devices (Eudamed), which is expected to go live on May 26, 2022. This marks a major milestone for medical device manufacturers, importers, and distributors that sell their products in the EU, as they will have to comply with new regulatory requirements and submit data to Eudamed.

Here`s a breakdown of what the Agreement Annex Eudamed entails and how it will impact your business:

Background

Eudamed is a central repository of information on medical devices that are placed on the EU market. It was first introduced in 2011 as a part of the Medical Devices Regulation (MDR) and the In-Vitro Diagnostic Regulation (IVDR), which aim to strengthen the safety and performance requirements for medical devices and IVDs in the EU.

The new MDR and IVDR regulations have been in effect since May 26, 2021, but the launch of Eudamed was delayed due to technical issues and the COVID-19 pandemic. The new system will replace the existing national databases and provide a single, searchable, and secure platform for various stakeholders to access and exchange information on medical devices, including:

– Manufacturers (including authorized representatives)

– Importers

– Distributors

– Notified Bodies

– Competent Authorities

Agreement Annex Eudamed

The Agreement Annex Eudamed is a legal document that defines the technical specifications and data elements that must be included in Eudamed. It also sets out the procedures for data submission and the governance of the system.

According to the annex, there are six modules in Eudamed, each with different functions and data requirements:

1. UDI-DI (Unique Device Identifier – Device Identifier): This module includes information on the device identifier and its associated product information.

2. Actors Registration: This module contains the registration data of various stakeholders involved in the medical device lifecycle, such as manufacturers, authorized representatives, importers, and distributors.

3. Certificates: This module includes certificates issued by notified bodies, which indicate that a medical device meets the safety and performance requirements of the MDR/IVDR.

4. Notified Bodies: This module contains the registration data of notified bodies, which are responsible for assessing the conformity of medical devices with the MDR/IVDR.

5. Vigilance & Post-Market Surveillance: This module includes data on adverse events and incidents related to medical devices that have been reported by patients, healthcare professionals, or other sources.

6. Clinical Investigations & Performance Studies: This module contains data on clinical investigations and performance studies of medical devices, including the study design, results, and conclusions.

Impact on Businesses

The launch of Eudamed will have significant implications for medical device businesses that sell their products in the EU. They will have to comply with new regulatory requirements and submit data to Eudamed, which may involve additional costs, resources, and expertise.

Some of the key impacts of Eudamed on businesses include:

– Compliance with MDR/IVDR: Businesses will have to comply with the new MDR/IVDR regulations and ensure that their medical devices meet the safety and performance requirements. This may require them to conduct additional tests, clinical studies, or redesign their products.

– Data Submission: Businesses will have to submit various data elements to Eudamed, depending on their roles and responsibilities. For example, manufacturers will have to provide information on their UDI-DI, product information, and clinical investigations. Importers will have to submit the registration data of their suppliers, while distributors will have to provide the registration data of their customers.

– Technical Expertise: Businesses will have to ensure that they have the technical expertise to submit data to Eudamed in the required format and comply with the technical specifications. This may require them to hire new staff or train their existing staff.

– Additional Costs: Businesses will have to bear the additional costs of complying with the new regulations and submitting data to Eudamed. This may include the cost of hiring consultants, upgrading their IT systems, or paying fees to Notified Bodies.

Conclusion

The Agreement Annex Eudamed marks a significant step towards establishing a centralized and transparent system for managing medical devices in the EU. However, it also presents challenges and opportunities for businesses that operate in this space. By preparing early and investing in the necessary resources and expertise, businesses can ensure that they comply with the new regulations and leverage the benefits of Eudamed to enhance their competitiveness and reputation.