GSPRs / Clinical Evaluation

P

Philip B

Quite Involved in Discussions
#1
#1
Does anyone know which GSPRs should specifically be supported in the clinical evaluation? MEDDEV 2.7.1 states (at least) MDD essential requirements 1, 3 and 6. Does anyone know what the expectation is for the MDR?
 
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Raisin picker

Raisin picker

Quite Involved in Discussions
#2
#2
There's no specific list, to my knowledge. I think you are expected to define yourself which GSPRs need to be supported in your CER. I've seen several variants. Minimum would be 1 and 8, but others could be argued as well.
 
Sam Lazzara

Sam Lazzara

Trusted Information Resource
#3
#3
Agreed.
For sure 1 and 8 since they are specifically mentioned in MDR Article 61.1. And via the mention of "relevant" GSPRs that leaves the door open for other GSPRs as well. So, definitely address GSPR 1 and 8, and consider others.

MDR Article 61.1 first sentence
Confirmation of conformity with relevant general safety and performance requirements set out in Annex I under the normal conditions of the intended use of the device, and the evaluation of the undesirable side-effects and of the acceptability of the benefit-risk- ratio referred to in Sections 1 and 8 of Annex I, shall be based on clinical data providing sufficient clinical evidence, including where applicable relevant data as referred to in Annex III.

Annex I. 1
Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. They shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art.

Annex I. 8
All known and foreseeable risks, and any undesirable side-effects, shall be minimised and be acceptable when weighed against the evaluated benefits to the patient and/or user arising from the achieved performance of the device during normal conditions of use.
 
R

RobertvanBoxtel

Involved In Discussions
#4
#4
In addition of the comment of @Sam Lazzara, start earlier in the MDR and read Article 5.3:
Demonstration of conformity with the general safety and performance requirements shall include a clinical evaluation in accordance with Article 61.
You determine which data in your clinical evaluation covers which GSPR's. But, in general the data should cover safety and performance aspects (lot's of those also in GSPR 10 and up), and the determination of the benefit of your device. Btw, when designing a new device, defining the benefit would be one of the first design activities you will have to do.
 
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