9. In relation to its responsibilities under this Article and the processing of personal data involved therein, the Commission shall be considered to be the controller of Eudamed and its electronic systems. Article 34 Functionality of Eudamed 1. The Commission shall, in collaboration with the MDCG, draw up the functional specifications for Eudamed. The Commission shall draw up a plan for the implementation of those specifications by … [12 months after the date of entry into force of this Regulation]. That plan shall seek to ensure that Eudamed is fully functional at a date that allows the Commission to publish the notice referred to in paragraph 3 of this Article by … [two months before the date of application laid down in this Regulation] and that all other relevant deadlines laid down in Article 123 of this Regulation and in Article 113 of Regulation (EU) 2017/… are met. 2. The Commission shall, on the basis of an independent audit report, inform the MDCG when it has verified that Eudamed has achieved full functionality and Eudamed meets the functional specifications drawn up pursuant to paragraph 1. 3. The Commission shall, after consultation with the MDCG and when it is satisfied that the conditions referred to in paragraph 2 have been fulfilled, publish a notice to that effect in the Official Journal of the European Union.
4. A clinical investigation as referred to in paragraph 1 may be conducted only where all of the following conditions are met: (a) the clinical investigation is the subject of an authorisation by the Member State(s) in which the clinical investigation is to be conducted, in accordance with this Regulation, unless otherwise stated; (b) an ethics committee, set up in accordance with national law, has not issued a negative opinion in relation to the clinical investigation, which is valid for that entire Member State under its national law; (c) the sponsor, or its legal representative or a contact person pursuant to paragraph 2, is established in the Union; (d) vulnerable populations and subjects are appropriately protected in accordance with Articles 64 to 68; (e) the anticipated benefits to the subjects or to public health justify the foreseeable risks and inconveniences and compliance with this condition is constantly monitored; (f) the subject or, where the subject is not able to give informed consent, his or her legally designated representative has given informed consent in accordance with Article 63; (g) the subject or, where the subject is not able to give informed consent, his or her legally designated representative, has been provided with the contact details of an entity where further information can be received in case of need; (h) the rights of the subject to physical and mental integrity, to privacy and to the protection of the data concerning him or her in accordance with Directive 95/46/EC are safeguarded; (i) the clinical investigation has been designed to involve as little pain, discomfort, fear and any other foreseeable risk as possible for the subjects, and both the risk threshold
* Regulation (EU) 2017/… of the European Parliament and of the Council of … on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L …, …, p. …).++'. Article 118 Amendment to Regulation (EC) No 178/2002 In the third subparagraph of Article 2 of Regulation (EC) No 178/2002, the following point is added: '(i) medical devices within the meaning of Regulation (EU) 2017/… of the European Parliament and of the Council*+. __________________ * Regulation (EU) 2017/… of the European Parliament and of the Council of … on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L …, …, p. …).'. Article 119 Amendment to Regulation (EC) No 1223/2009 In Article 2 of Regulation (EC) No 1223/2009, the following paragraph is added: '4. The Commission may, at the request of a Member State or on its own initiative, adopt the necessary measures to determine whether or not a specific product or group of products falls within the definition 'cosmetic product'. Those measures shall be adopted in accordance with the regulatory procedure referred to in Article 32(2).'. Article 120 Transitional provisions 1. From … [date of application of this Regulation], any publication of a notification in respect of a notified body in accordance with Directives 90/385/EEC and 93/42/EEC shall become void.
(d) In the case of devices containing CMR or endocrine-disrupting substances referred to in Section 10.4.1 of Annex I, the justification referred to in Section 10.4.2 of that Annex. (e) In the case of devices placed on the market in a sterile or defined microbiological condition, a description of the environmental conditions for the relevant manufacturing steps. In the case of devices placed on the market in a sterile condition, a description of the methods used, including the validation reports, with respect to packaging, sterilisation and maintenance of sterility. The validation report shall address bioburden testing, pyrogen testing and, if applicable, testing for sterilant residues. (f) In the case of devices placed on the market with a measuring function, a description of the methods used in order to ensure the accuracy as given in the specifications. (g) If the device is to be connected to other device(s) in order to operate as intended, a description of this combination/configuration including proof that it conforms to the general safety and performance requirements when connected to any such device(s) having regard to the characteristics specified by the manufacturer.
(b) The UDI carrier shall be readable, or, in the case of AIDC, scannable, whether placed on the outside of the packaging of the system or procedure pack or inside transparent packaging. 6.4. Configurable devices: 6.4.1. A UDI shall be assigned to the configurable device in its entirety and shall be called the configurable device UDI. 6.4.2. The configurable device UDI-DI shall be assigned to groups of configurations, not per configuration within the group. A group of configurations is defined as the collection of possible configurations for a given device as described in the technical documentation. 6.4.3. A configurable device UDI-PI shall be assigned to each individual configurable device. 6.4.4. The carrier of the configurable device UDI shall be placed on the assembly that is most unlikely to be exchanged during the lifetime of the system and shall be identified as the configurable device UDI. 6.4.5. Each component that is considered a device and is commercially available on its own shall be assigned a separate UDI. 6.5. Device Software 6.5.1. UDI assignment Criteria The UDI shall be assigned at the system level of the software. Only software which is commercially available on its own and software which constitutes a device in itself, shall be subject to that requirement. The software identification shall be considered to be the manufacturing control mechanism and shall be displayed in the UDI-PI. 6.5.2. A new UDI-DI shall be required whenever there is a modification that changes: (a) the original performance;
ANNEX XII CERTIFICATES ISSUED BY A NOTIFIED BODY Chapter I General Requirements 1. Certificates shall be drawn up in one of the official languages of the Union. 2. Each certificate shall refer to only one conformity assessment procedure. 3. Certificates shall only be issued to one manufacturer. The name and address of the manufacturer included in the certificate shall be the same as that registered in the electronic system referred to in Article 30. 4. The scope of the certificates shall unambiguously identify the device or devices covered: (a) EU technical documentation assessment certificates, EU type-examination certificates and EU product verification certificates shall include a clear identification, including the name, model and type, of the device or devices, the intended purpose, as included by the manufacturer in the instructions for use and in relation to which the device has been assessed in the conformity assessment procedure, risk classification and the Basic UDI-DI as referred to in Article 27(6); (b) EU quality management system certificates and EU quality assurance certificates shall include the identification of the devices or groups of devices, the risk classification, and, for class IIb devices, the intended purpose. 5. The notified body shall be able to demonstrate on request, which (individual) devices are covered by the certificate. The notified body shall set up a system that enables the determination of the devices, including their classification, covered by the certificate.