Clinical Evaluation For Instruments - Class I, Class Ir, Class Im, and Class IIa - EU MDR

[jbm12]

Hello Everyone, In regards to creating a CER for instruments I am very confused about how to obtain clinical data for instruments (Class I & Class Ir, Class Im, Class IIa). I know there is the route of write a justification for exemption under Article 61, section 10, which states "...where the demonstration of conformity with general safety and performance requirements based on clinical data is not deemed appropriate, adequate justification for any such exception shall be given based on the results of the manufacturer's risk management and on consideration of the specifics of the interaction between the device and the human body, the clinical performance intended and the claims of the manufacturer".

For example, in the case of a new product development how would a person claim equivalence to another similar device when It comes to instruments?

I know for implants we would conduct a clinical study, gather clinical literature, and PMS data (FSCA, PI and Sales, NC CAPA data). But for instruments we only have preclinical testing - mechanical testing, design validation protocols and reports, biocompatibility testing then stating our instruments clinical benefit is to help facilitate the implant during surgery.

Since there is not usually clinical studies for instruments and clinical data/literature on instruments clinical benefit how would one go about claiming equivalence to another device from an instrument perspective?

 

[Ronen E]

Following from our previous discussion, I assume we're discussing orthopedic devices and accessories. I'm not an expert in this application field, so the below is more generic. Hopefully you'll be able to find someone with MDR submission & certification experience more specific to orthopedics.

First, the statement of specific clinical benefits (see MDR Article 2(53)) can be a mine field. It seems that "help facilitate the implant during surgery" doesn't meet the definition in s. 53. Apparently you're allowed to state that the device (or accessory) doesn't have Clinical Benefits (as per the definition) - when this is actually the case - and proceed from there (I haven't gone down this path in the real world so I'm not sure how it should unfold; but I received this indication from a NB clinical reviewer - FWIW).

For determining equivalence, see MDCG 2020-5. There are more aspects to equivalence than just clinical.

 

[Raisin picker]

If you developed an implantation specific instrument in parallel with your implant, you should add the instrument to your implant trial. Especially when the instrument is required, that should be no big deal. Create a (short) questionnaire regarding the instrument use, and if you have an observer in theater, make him fill some observations on the instrument use.

I wouldn't expect a justification regarding article 61(10) or WET (MDCG 2020-6) to be accepted by the NB for a new instrument.

 

[jbm12]

@Raisin picker How about claiming article 61 (10) for general instruments we will be using for facilitation of insertion of the implant. Then I am thinking i could back it up with mechanical testing, biocompatiblity, validation lab protocols and reports.

Then gathering clinical literature, and Post Market Surveillance data in regard to the competitor/ similar equivalent devices. For example the instruments would be Lipped blades, table mount arms, fixation pin and drivers, resusable light cable adapters, sterile guidewires, dilators, ligh tip, retractor and blades, cobbs, curettes, rasps, disc wedges, trials, rasps.

 

[jbm12]

@Raisin picker & @Ronen E I also want to specifically point out retractor systems since they are inserting the implant into the body there would be direct contact, but i am assuming we could still apply article 61 (10) since there is no clinical claim? For example i understand if there is a claim such as the instrument will help reduction in surgery time but in this case we do not have that.