The Medical Device Coordination Group (MDCG), an advisory body of the European Commission in the sphere of medical devices, has published a Q&A document dedicated to the regulatory requirements for registration in EUDAMED, the new EU-wide database, of actors other than manufacturers, authorized representatives and importers.
It is important to mention that due to the legal nature of the document the provisions thereof are not binding and are intended only to provide additional recommendations and clarifications on the matter.
The present document is intended to provide additional clarifications regarding the registration in EUDAMED of actors other than manufacturers, authorized representatives, and importers in accordance with the rules set forth under the new regulatory framework for medical devices introduced by the Medical Devices Regulation 2017/745 (MDR) and the In Vitro Diagnostic medical devices Regulation 2017/746 (IVDR). Additionally, the document provides information on situations when an Actor ID should be used instead of an SRN.
First, the document provides definitions of the most important terms and concepts used in the applicable regulations, including the following:
- Actor ID – the identifier issued to all actors registered in EUDAMED for their identification in the system. This element will be issued immediately after the approval of the request for registration.
- SRN – the Single Registration Number that is issued through EUDAMED to manufacturers, authorized representatives and importers by the competent authority in accordance with Article 31 MDR and 28 IVDR.
- Old devices – ones placed on the market according to the medical devices Directives or the in vitro diagnostic medical devices Directive before the date of application of the MDR and IVDR or placed on the market before the Directives entered into force.
Regulatory Approach in Detail
Further, the document provides detailed answers to the most common questions regarding how the new database should be used. The questions cover such aspects as the registration procedure, the scope of entities subject to registration, applicable timelines, the scope of devices covered by the new regulation, and also the main points related to the respective regulating authorities and their functions.
1. Actor registration procedure. At the moment, the final document that will describe in detail the registration procedure for actors is still under development. According to the present guidance, the related matters would be addressed by a Commission Implementing Regulation on EUDAMED. The rules and procedures to be described therein will be applicable for any and all parties involved in operations with medical devices, including both natural and legal persons. As mentioned, the request for registration should be subject to approval by the relevant authority. The MDCG additionally emphasizes that if an actor who, under the general rule, is not subject to mandatory registration in EUDAMED, applies for such registration in order to be able to notify about a serious adverse event or a field safety corrective action (FSCA), the appropriate report should be directly filed to the national competent authority together with the request for registration in EUDAMED. The aforementioned request should also contain the indication of the actual reason for applying – the adverse event to be reported. However, once the approval is granted, the responsible party will have to submit information about an adverse event or FSCA to EUDAMED despite the fact such information has already been communicated directly to the competent authority.
2. Special rules for custom-made medical devices. In the case of custom-made medical devices, their manufactures are not required to apply for registration before the device has been placed on the market. At the same time, they are still obliged to submit certain information to EUDAMED, and registration is required to be able to do this. Under the general rule, notified bodies conducting conformity assessment of Class III custom-made implantable medical devices are obliged to upload information associated thereto to the new database. The reporting obligations of manufacturers of custom-made medical devices also cover serious incidents, FSCAs, and notices associated thereto, as well as non-serious incidents occurring several times. Thus, according to the document, the manufacturer that produces only custom-made medical devices will have to apply for the registration in EUDAMED only for submitting the reports as described above. Additionally, they are allowed to register to provide information about their Class III custom-made medical devices. The rules described herein should also be applied in the case of foreign medical device manufacturers based outside the EU, as well as their authorized representatives. In such a case, the identification element to be assigned will be an Actor ID, and not an SRN.
3. Special rules for legacy devices. According to the present MDCG guidance, the manufacturers of legacy devices are also obliged to apply for registration as actors. The particular timelines for such registration could be prescribed by the applicable national regulations related to the transitional period. As with the previous one, this rule applies not only to the EU-based manufacturers but also to those based outside the EU, as well as their authorized representatives. The identification element to be assigned will also be an Actor ID.
4. Special rules for “old” devices. The document also describes the rules and procedures to be applied in the case of medical devices placed on the market under the previous frameworks – under the Directives or even before. The manufacturers of such products would also have to register in EUDAMED as actors only in case this will be needed to submit the appropriate adverse event report or notification on FSCA. This also applies to foreign medical device manufacturers and their authorized representatives unless they are no longer active. The same as in previous cases described hereabove, the identification number to be assigned will be an Actor ID.
5. Special rules for systems and procedures. The guidance provides clarifications regarding special rules to be applied in the case of system and procedure pack producers (SPPP). It is stated that according to Article 29 (2) MDR, before placing a system or procedure pack on the market, the natural or legal person responsible (SPPP) has an obligation to assign a basic UDI-DI to be provided to the UDI database, together with the other data referred to in Part B of Annex VI MDR. Thus, under the applicable regulations, such entities shall register before placing their products on the market. In certain cases, such registration could also be required under the applicable national legislation. Since they should register as actors, the appropriate Actor ID should be duly assigned upon approval of the registration request.
6. Determination of the competent authority. According to the present MDCG guidance, the determination of competent authority to be responsible for the registration of an actor should be based on the jurisdiction where an SPPP will be placed on the market for the first time.
In summary, the present questions and answers document issued by the MDCG covers the most important aspects related to the registration of actors in EUDAMED. In particular, the document addresses the regulatory matters related to the custom-made, legacy and old medical devices, as well as systems and procedure packs.
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