EU MDR Article 61- Clinical Evaluation

tiptoe

Starting to get Involved
#1
Hi there,

I am reviewing MDR Article 61 and I am a little confused. So for section 4 through 6 (see below), I assume these only apply to Class III and implantable devices? Will that mean then that for Class II a devices:
1) no clinical investigation is required in addition to the clinical evaluation?
2) there's no contract needed between manufacturer and the manufacturer of equivalent device in order to use their information to demonstrate equivalence?

Thanks
" 4. In the case of implantable devices and class III devices, clinical investigations shall be performed, except if:
— the device has been designed by modifications of a device already marketed by the same manufacturer,
— the modified device has been demonstrated by the manufacturer to be equivalent to the marketed device, in accordance with Section 3 of Annex XIV and this demonstration has been endorsed by the notified body, and
— the clinical evaluation of the marketed device is sufficient to demonstrate conformity of the modified device with the relevant safety and performance requirements.
In this case, the notified body shall check that the PMCF plan is appropriate and includes post market studies to demonstrate the safety and performance of the device.
In addition, clinical investigations need not be performed in the cases referred to in paragraph 6.
5. A manufacturer of a device demonstrated to be equivalent to an already marketed device not manufactured by him, may also rely on paragraph 4 in order not to perform a clinical investigation provided that the following conditions are fulfilled in addition to what is required in that paragraph:
— the two manufacturers have a contract in place that explicitly allows the manufacturer of the second device full access to the technical documentation on an ongoing basis, and
— the original clinical evaluation has been performed in compliance with the requirements of this Regulation,
and the manufacturer of the second device provides clear evidence thereof to the notified body.
6. The requirement to perform clinical investigations pursuant to paragraph 4 shall not apply to implantable devices and class III devices:
(a) which have been lawfully placed on the market or put into service in accordance with Directive 90/385/EEC or Directive 93/42/EEC and for which the clinical evaluation:
— is based on sufficient clinical data, and
— is in compliance with the relevant product-specific CS for the clinical evaluation of that kind of device, where such a CS is available; or

(b) that are sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips or connectors for which the clinical evaluation is based on sufficient clinical data and is in compliance with the relevant product-specific CS, where such a CS is available."
 
Elsmar Forum Sponsor

Marcelo

Inactive Registered Visitor
#2
Yes, 4-6 applies only to implantable devices and class II devices. In fact, it's exactly like the MDD.

What changed is that the MDD mentioned that a clinical investigation may not be performed if the was good justification based on clinical data, and most of the time clinical investigations were not performed with bad justifications. The MDR changed this "justification"with an algorithm (item 4-6) which puts several clear restrictions for not performing a clinical investigations. For example, it's basically impossible to use clinical data from an equivalent device from other companies, because of item 5.

This is in line with the hight expectation of clinical data from most regulations, in particular in the case of "high risk" devices.
 
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