I am having a bit a trouble identifying in the MDR when the requirements for clinical investigations are effective.
Article 120 (transitional provisions) says:
" By way of derogation from Article 5 of this Regulation, a device with a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and which is valid by virtue of paragraph 2 of this Article may only be placed on the market or put into service provided that from the date of application of this Regulation it continues to comply with either of those Directives, and provided there are no significant changes in the design and intended purpose. However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives."
So this does not mention clinical investigation requirements in the list of requirements to be met as of the date of application, even with an MDD certificate. But it also says:
"Clinical investigations which have started to be conducted in accordance with Article 10 of Directive 90/385/EEC or Article 15 of Directive 93/42/EEC prior to 26 May 2020 may continue to be conducted. As of 26 May 2020, however, the reporting of serious adverse events and device deficiencies shall be carried out in accordance with this Regulation."
Does this imply that any clinical investigations that start after May 26 2020 must meet all MDR requirements for clinical investigations, even if our device certificate is still under the MDD? Or are the clinical investigation requirements only effective once we obtain an MDR certificate?
Article 123 says:
"without prejudice to the obligations on the Commission pursuant to Article 34, where, due to circumstances that could not reasonably have been foreseen when drafting the plan referred to in Article 34(1), Eudamed is not fully functional on 26 May 2020, the obligations and requirements that relate to Eudamed shall apply from the date corresponding to six months after the date of publication of the notice referred to in Article 34(3). The provisions referred to in the preceding sentence are: Articles 70-77"
This lumps clinical investigation requirements in with the requirements that are only effective 6 months after Eudamed is fully functional. But again, is this if our device certificate is still under the MDD, or only once we have an MDR certificate?
If anyone knows, please advise!
Article 120 (transitional provisions) says:
" By way of derogation from Article 5 of this Regulation, a device with a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and which is valid by virtue of paragraph 2 of this Article may only be placed on the market or put into service provided that from the date of application of this Regulation it continues to comply with either of those Directives, and provided there are no significant changes in the design and intended purpose. However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives."
So this does not mention clinical investigation requirements in the list of requirements to be met as of the date of application, even with an MDD certificate. But it also says:
"Clinical investigations which have started to be conducted in accordance with Article 10 of Directive 90/385/EEC or Article 15 of Directive 93/42/EEC prior to 26 May 2020 may continue to be conducted. As of 26 May 2020, however, the reporting of serious adverse events and device deficiencies shall be carried out in accordance with this Regulation."
Does this imply that any clinical investigations that start after May 26 2020 must meet all MDR requirements for clinical investigations, even if our device certificate is still under the MDD? Or are the clinical investigation requirements only effective once we obtain an MDR certificate?
Article 123 says:
"without prejudice to the obligations on the Commission pursuant to Article 34, where, due to circumstances that could not reasonably have been foreseen when drafting the plan referred to in Article 34(1), Eudamed is not fully functional on 26 May 2020, the obligations and requirements that relate to Eudamed shall apply from the date corresponding to six months after the date of publication of the notice referred to in Article 34(3). The provisions referred to in the preceding sentence are: Articles 70-77"
This lumps clinical investigation requirements in with the requirements that are only effective 6 months after Eudamed is fully functional. But again, is this if our device certificate is still under the MDD, or only once we have an MDR certificate?
If anyone knows, please advise!