smuffybuffy
Registered
Help needed:
We are trying to achieve iso 13485 certificates and this is our current set up:
We are combining a PPE 12942 certified product (main product) that consists of 4 PPE 12942 certified accessories. We have added an additional accessory to this setup that allows us to market the product as a medical device (the added product itself is not medical but it performs a medical service as it prevents the patient from being infected), under article 22 as a system. The combination of CE products have a certificate of "combination conformity"
To my question:
Q1: When combining products with different CE marks under article 22, do all requirements for the medical device also fall on the combined PPE CE marked products?
PPE CE-by notified body:
1 software -included in the PPE CE marked standard
2 battery-included in the PPE CE marked standard
3 Accessory 1-4 included in the PPE CE marked standard
4 electrical pump included in the PPE CE marked standard
- for instance- Does the software/ electrical pump need to be evaluated in the medical products risk assessment or clinical evaluation when both software/ electrical pump is handled within their own PPE CE mark? IF not then the requirements of the MDR must be applied and checked on every product that is not a medical device and evaluate as if they were medical devices, which then MDR in effect could never facilitate multiple CE marked mEdical device consisting of both PPE CE and Medical Device CE marked products placed into one system.
Q2- article 22 (2c) of MDR -"the activity of combining devices and, if applicable, other products as a system or procedure pack was subject to appropriate methods of internal monitoring, verification, and validation." Is this the answer to Q1:-
a system composed of
1-that Medical device product should be handled and validated according to MDR & iso 13485 requirements
2- the combination procedure/activity should be assessed in risk management procedure and GSPR,
3- PPE CE products validated according to ISO 12942 requirements
Q3- Does GSPR (and maybe risk assessment activity) only handle the part of the combined products in the System that pertains to the medical device?
Thank you very much for any answers given.
We are trying to achieve iso 13485 certificates and this is our current set up:
We are combining a PPE 12942 certified product (main product) that consists of 4 PPE 12942 certified accessories. We have added an additional accessory to this setup that allows us to market the product as a medical device (the added product itself is not medical but it performs a medical service as it prevents the patient from being infected), under article 22 as a system. The combination of CE products have a certificate of "combination conformity"
To my question:
Q1: When combining products with different CE marks under article 22, do all requirements for the medical device also fall on the combined PPE CE marked products?
PPE CE-by notified body:
1 software -included in the PPE CE marked standard
2 battery-included in the PPE CE marked standard
3 Accessory 1-4 included in the PPE CE marked standard
4 electrical pump included in the PPE CE marked standard
- for instance- Does the software/ electrical pump need to be evaluated in the medical products risk assessment or clinical evaluation when both software/ electrical pump is handled within their own PPE CE mark? IF not then the requirements of the MDR must be applied and checked on every product that is not a medical device and evaluate as if they were medical devices, which then MDR in effect could never facilitate multiple CE marked mEdical device consisting of both PPE CE and Medical Device CE marked products placed into one system.
Q2- article 22 (2c) of MDR -"the activity of combining devices and, if applicable, other products as a system or procedure pack was subject to appropriate methods of internal monitoring, verification, and validation." Is this the answer to Q1:-
a system composed of
1-that Medical device product should be handled and validated according to MDR & iso 13485 requirements
2- the combination procedure/activity should be assessed in risk management procedure and GSPR,
3- PPE CE products validated according to ISO 12942 requirements
Q3- Does GSPR (and maybe risk assessment activity) only handle the part of the combined products in the System that pertains to the medical device?
Thank you very much for any answers given.
