Clinical Investigations under MDR

lisasolo

Starting to get Involved
#1
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!
 
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Marcelo

Inactive Registered Visitor
#2
I think you are confusing a lot of things here. It's in reality really simple.

The Article that governs the application of most of the regulations is:

Article 123
Entry into force and date of application
1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
2. It shall apply from 26 May 2020.
That's it. So the clinical investigation portion of the MDR is applicable on the day of application.

Article 123 3d) is only related to the obligations of transmission of electronic information in Eudamed:

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:
So only these parts of Articles 70 to 77 (the Eudamed requirements) are affect by Article 123 3d).
 

lisasolo

Starting to get Involved
#3
OK thank you for the reply.

I just would have expected to see clinical investigations listed in this statement, if the requirements apply even while our device is still governed by an MDD certificate:

"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."

I was under the impression that only the items listed here are required as of the date of application, until your device is certified under the MDR. Thanks!
 

Marcelo

Inactive Registered Visitor
#4
"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."

I was under the impression that only the items listed here are required as of the date of application, until your device is certified under the MDR. Thanks!
This is true, but only for one of the aspects of the scope of MDR.

The MDR has two aspects in scope:

This Regulation lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such devices in the Union.
This Regulation also applies to clinical investigations concerning such medical devices and accessories conducted in the Union.
The topic you mentioned is applicable to the first aspect.

The second aspect (application to clinical investigations) is a separate one.
 
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