Access to Technical Documentation - MDR Chapter VI Article 61

[Chrisx]

I was wondering if anyone could provide some more clarity on the requirement below from the MDR? It was always my interpretation that the requirement regarding providing complete access to the technical documentation of equivalent devices only applies to class III and implantables. This was my interpretation because paragraph 5 references paragraph 4. Paragraph 4 only applies to class III and implantables. However, recently I have heard some individuals interpret this to apply to all devices regardless of class.

Thanks,
ChrisX

Chapter VI Article 61
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.

 

[pkost]

The purpose of Article 61 is give a situation where a clinical investigation is not required, when it would otherwise be required due to the device being implantable or class III. It is not intenteded to relate to any other part of the technical documenation

There is no requirement about access to the technical file of equivalent devices, as the manufacturer cannot be expected to ever have this. The manufacturer must however hold a complete technical file for their device regardless of classification - this has always been the case.

 

[Chrisx]

Thanks for following up so quickly. It would seem that Article 61 paragraph 5 does require access to the technical documentation. It states " 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". My question is does this apply only to class III and implants.

Thanks,
ChrisX

 

[pkost]

As I said - this only applies to the requirement to do a clinical investigation

The MDR requires that all class III and implantable devices undergo clinical investigation, Article 61(5) permits the manufacturer to forgo a clinical investigation if there is an equivalent device to which the manufacturer has access to the technical file, normally this would be your own equivalent device, but paragraph 5 recognises that there may be an occassion when the equivalent device is manufactured by another entity, therefore an agreement is put in place to access their technical file in lieu of conducting another clinical investigation. This applies to all class of devices

It is important to note that the article does not permit you to rely on a different technical file in lieu of your own - you must still have your own technical file

 

[Valerie Bennett]

Thanks @pkost. I find this to be one of the most misunderstood parts of Equivalence. I too used to think that you would be looking to ask your competitors for all of their technical documentation and correct me if I wrong, that is not the meaning of this.

Instead, it should be looked at from the manufacturing perspective where two entities have a contractual commitment. Then there is also the case of a manufacturer using their own device to demonstrate Equivalence but I think that requires caution depending upon the device.

I believe that this is similar into what the FDA is trying to eliminate aka "predicate creep" . One device claims that it is equivalent (or a predicate, then another uses the same, and so on). Pretty soon, the predicate could potentially be a legacy device.

I appreciate any feedback, corrections or perhaps a different way of stating this.