Combined advanced therapy medicinal products
Article 4
1. Where an application for certification relates to combined advanced therapy medicinal products, the additional requirements set out in paragraphs 2 and 3 shall apply. 2. The application for certification of data related to a combined advanced therapy medicinal product may include evidence of conformity with the essential requirements referred to in Article 6 of Regulation (EC) No 1394/2007. 3. The application for certification of data related to a combined advanced therapy medicinal product shall include, where available, the results of the assessment by a notified body in accordance with Directive 93/42/EEC or Directive 90/385/EEC of the medical device part or active implantable medical device part. The Agency shall recognise the results of that assessment in its evaluation of the data concerning the medicinal product concerned. The Agency may request the relevant notified body to transmit any information related to the results of its assessment. The notified body shall transmit the information within a period of one month. In that case, the period referred to in Article 2(3) shall be suspended until the information requested has been provided. 4. If the application does not include the results of the assessment, the Agency may (a) seek an opinion on the conformity of the device part with Annex I to Directive 93/42/EEC or Annex 1 to Directive 90/385/EEC from a notified body identified in conjunction with the applicant, unless the Committee for Advanced Therapies advised by its experts for medical devices decides that involvement of a notįfied body is not required; or (b) exclude from the evaluation the check of conformity of the medical device with the essential requirements referred to in Article 6 of Regulation (EC) No 1394/2007. In the case referred to in point (a), the period referred to in Article 2(3) shall be suspended until the opinion requested has been provided. In the case referred to in point (b), the evaluation report and any certificate provided shall record the fact that the evaluation excludes the check of conformity of the medical device with the essential requirements. The evaluation report and any certificate provided may also conclude that the interaction and compatibility between the cells or tissues and the medical device cannot be evaluated in the absence of the results of the assessment by a notified body.