Does someone have an example of a procedure pack statement persuant to article 22 to share?
We're going to EU market with a procedure pack containing 2 of our own devices and one device CE marked by another manufacturer. We have verified the mutual compatibility in verification and validation activities. Now we're wondering about the extensiveness of the statement that we must draw up. Could it be a simple statement or should it contain references to verification and validation activities?
Article 22
Systems and procedure packs
1. Natural or legal persons shall draw up a statement if they combine devices bearing a CE marking with the
following other devices or products, in a manner that is compatible with the intended purpose of the devices or other
products and within the limits of use specified by their manufacturers, in order to place them on the market as a system
or procedure pack:
(a) other devices bearing the CE marking;
(b) in vitro diagnostic medical devices bearing the CE marking in conformity with Regulation (EU) 2017/746;
(c) other products which are in conformity with legislation that applies to those products only where they are used
within a medical procedure or their presence in the system or procedure pack is otherwise justified.
2. In the statement made pursuant to paragraph 1, the natural or legal person concerned shall declare that:
(a) they verified the mutual compatibility of the devices and, if applicable other products, in accordance with the manufacturers'
instructions and have carried out their activities in accordance with those instructions;
(b) they packaged the system or procedure pack and supplied relevant information to users incorporating the
information to be supplied by the manufacturers of the devices or other products which have been put together;
(c) 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.
We're going to EU market with a procedure pack containing 2 of our own devices and one device CE marked by another manufacturer. We have verified the mutual compatibility in verification and validation activities. Now we're wondering about the extensiveness of the statement that we must draw up. Could it be a simple statement or should it contain references to verification and validation activities?
Article 22
Systems and procedure packs
1. Natural or legal persons shall draw up a statement if they combine devices bearing a CE marking with the
following other devices or products, in a manner that is compatible with the intended purpose of the devices or other
products and within the limits of use specified by their manufacturers, in order to place them on the market as a system
or procedure pack:
(a) other devices bearing the CE marking;
(b) in vitro diagnostic medical devices bearing the CE marking in conformity with Regulation (EU) 2017/746;
(c) other products which are in conformity with legislation that applies to those products only where they are used
within a medical procedure or their presence in the system or procedure pack is otherwise justified.
2. In the statement made pursuant to paragraph 1, the natural or legal person concerned shall declare that:
(a) they verified the mutual compatibility of the devices and, if applicable other products, in accordance with the manufacturers'
instructions and have carried out their activities in accordance with those instructions;
(b) they packaged the system or procedure pack and supplied relevant information to users incorporating the
information to be supplied by the manufacturers of the devices or other products which have been put together;
(c) 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.
