For each device, the manufacturer shall confirm conformity with relevant General Safety and Performance Requirements (GSPR) under the normal conditions of the intended use of the device, and the evaluation of the undesirable side-effects and of the acceptability of the benefit-risk ratio. This confirmation shall be based on clinical data providing sufficient clinical evidence, including where applicable relevant data as referred to in Annex III of MDR. For in vitro diagnostic devices, confirmation is based on performance data.

The clinical data is collected and compiled in the scope of a clinical evaluation, which follows a rigorous clinical plan. Clinical Evaluation Reports are required for all medical devices in Europe. Likewise, Performance Evaluation Reports are required for in vitro diagnostic medical devices. The regulatory unit supports the manufacturers by elaborating Clinical Evaluation Reports and Performance Evaluation Reports to demonstrate conformity to the GSPR, according to devices’ intended use.

A medical device or material that comes in contact with the patient is expected to perform its intended function without resulting in any adverse effect. For this reason, medical devices are typically subject to biological evaluation and biocompatibility testing to assess the interaction between a device and a tissue, cells or body fluids of the patient. The primary purpose of a device biocompatibility assessment is to protect the patient from potential biological risks.

The biological evaluation consists of a continuous process to identify specific biological hazards associated with the devices, estimate and evaluate its risks, and monitor control effectiveness.

The ISO 10993 series provides guidelines and requirements for manufacturers to appropriately mitigate the biological risks to an acceptable benefit/risk level, including testing to confirm biocompatibility. The biological evaluation of any material or medical device intended for use in humans shall be a part of a structured biological evaluation plan within a risk management process in accordance with ISO 14971.

Finally, all relevant evidence is summarized in a biological evaluation report (BER), where a final conclusion and a statement on biocompatibility and safety is provided for the use of the device within its intended purpose in the intended patient population. The regulatory unit assists in the collection of all the data to compile the BER, including the definition of necessary tests and selection of adequate laboratories. If applicable, our unit also assists with the elaboration of a BER based on equivalence.

Registration of manufacturers, authorized representatives and importers

According to Article 31 of Regulation 745/2017 and Regulation 746/2017, economic operators must register with EUDAMED in order to obtain a Single Registration Number (SRN) by submitting information via the appropriate database module.

What are economic operators?

According to the definitions in Regulation 2017/745 (MDR) and Regulation 2017/746 (IVDR), an “economic operator” is a manufacturer, authorized representative, importer, distributor or producer (or persons who sterilize) of systems or kits for interventions.

According to the European Commission, an actor is a natural or legal person (organization) with a specific role in the manufacture and marketing of devices and who must be registered with EUDAMED. Thus, each economic operator is an actor for the purposes of using EUDAMED.

The economic operator will obtain a unique SRN for each actor role. If the economic operator has several roles, separate registration applications are required to obtain a different and specific SRN for each actor role.

*Importers are companies that purchase medical devices directly from manufacturers outside the European Union.

Please note: Distributors must not register with EUDAMED. For distributors, the national rules of each Member State apply.

How is registration processed?

The information relating to each economic operator, as defined in Annex VI, Part A, Section 1 of the Regulations described above, is entered into EUDAMED and, once validated by the corresponding national competent authority, the economic operator receives an SRN following an email notification. The validation time depends on the authorized representative (where applicable) and the competent authority.

What information is needed for registration?

• Information on the organization to be registered;
• Identification of the Competent Authority related to the manufacturer or authorized representative;
• Declaration of the authorized representative and details of the authorized representative, if applicable (EUDAMED specific template);
• Declaration regarding responsibilities for information security (EUDAMED-specific template);
• Identification of the Person Responsible for Regulatory Compliance (PRRC)

What is the importance of SRN?

• Traceability and transparency
• Access for registration of devices with EUDAMED
• Identification of the operator for the purposes of submitting requests for assessment by Notified Bodies
• Identification in the EU Declaration, CE certificates, Safety and Performance Summaries
• Identification in Technical Documentation, Reports and other post-market monitoring and surveillance documents

The regulatory support unit team can help you with EUDAMED registration and help your company register its products.