Regulatory Open Forum

First, recognize that there four types of procedure pack. One type meets Art 22(1), while the other three are in Art. 22(4). The first type does not a CE Mark or NB involvement. The other three types are devices in their own right. They follow the Art. 52 conformity assessment and the natural or legal person is a manufacturer.

In all four cases the name of the natural or legal person is on the product. In the first case through Art. 22(5) and in the other cases through the manufacturer requirements.

For vigilance, Art. 87(1) applies to manufacturers, but not to any of the other five economic operators.

Good morning,

@Dan O'Leary I'm not sure if I understand correctly this interpretation of Art.22. This only confirms that there is no clear interpretation guide for Article 22.

For my understanding PPP can have the PP that meets Art.22 (1),(2) and (3) and still not follow the Art.52...means, without bear an additional CE marking on PP label.

If PPP has all components CE marked, he can create his  PP ​(Art.22 (1, 2)), sterilize (Art.22 (3)) and follow the Art.22 (5).

In the Art.22 (3) it is clearly stated that ..."application of those procedures  (Annex IX or Part A of Annex X) and the involvement of the notified body shall be limited to the aspects of the procedure relating to ensuring sterility until the sterile packaging is opened or damaged. The natural or legal person shall draw up a statement declaring that sterilisation has been carried out in accordance with the manufacturer's instructions".

For my understanding, if PPP needs to follow the component specific "manufacturer's instructions"  he can't be consider Manufacturer fully responsible as per Art.52. The PPP shall draw up a statement (formal, documented) to that effect. Alternatively, the manufacturer of component needs to confirm that the PPP sterilization parameters conform to those of the manufacturer.

PPP shall obtain certification for the sterilisation activities from a NB as per Art. 22 (3). If the responsibility of PPP is limited to the sterilization, also vigilance obligations should be limited to these aspects.

Usually, PPP has no knowledge to perform very deep root cause analysis if the incident is caused by specific CE marked component. It is obligation of component device manufacturer to follow Art.87 (bdw EUDAMED Vigilance module – VGL is available only for Manufacturers https://ec.europa.eu/health/sites/health/files/md_eudamed/docs/md_eudamed_fs_v4_1_en.pdf)
... The root cause of the incident may be with the manufacturer's device itself (component manufacturer's responsibility), or with the PPP's assembly of the PP i.e. with the  combination/configuration, processing/sterilisation etc. of the components of the pack => then the responsibility lies with the PPP.

I believe that there is not enough clarity on this topic...

Thank you again.

First, recognize that there four types of procedure pack. One type meets Art 22(1), while the other three are in Art. 22(4). The first type does not a CE Mark or NB involvement. The other three types are devices in their own right. They follow the Art. 52 conformity assessment and the natural or legal person is a manufacturer.

In all four cases the name of the natural or legal person is on the product. In the first case through Art. 22(5) and in the other cases through the manufacturer requirements.

For vigilance, Art. 87(1) applies to manufacturers, but not to any of the other five economic operators.

I find Article 22 straightforward and simple. However, there is a lot going on, so it is necessary to separate the activities. Also, I'm going to avoid PP, PPP, PPPP, ad infinitum because I think they mask the correct distinctions.

Start with the Art. 2(35) definition of economic operator. For this discussion, they are "the person referred to in Article 22(1) and 22(3)". The person in Art. 22(1) combines "devices bearing a CE marking with the following other devices or products …". The person in Art. 22(3) sterilizes Art. 22(1) procedure packs. In common practice one person combines and another person sterilizes. In other words, the person in Article 22(3) could be a contract sterilizer. The same person could have both roles. The Art. 22(3) sterilizer, requires Notified Body involvement for the sterilization aspects. The person who combines the Art. 22(1) procedure pack does not need Notified Body involvement. Some Art. 22(1) procedure packs require sterilization and some do not. Be careful to distinguish the roles.

There are, by my count, four types of procedure packs. One is from Art. 22(1) and three are from Art. 22(4).

For an Art. 22(1) procedure pack, the person prepares the Art. 22(22) statement, does not put CE Mark on the procedure pack, includes the Art. 22(1) combiner's identity, and includes the information from Annex I(23).

If the procedure pack is sterilized, then it also includes the Art. 22(3) sterilizer's identity.

For any of the Art. 22(4) procedure packs, it is a device in its own right, it follows the appropriate Article 52 conformity assessment procedure, and the natural or legal person assumes the obligations incumbent on manufacturers.

Here is my model for implementation.
Determine that the product is a procedure pack following the definition in Art. 2(10).

Classify the procedure pack as either Art. 22(1) or Art. 22(4).

Determine if the procedure pack requires sterilization and, if so, identify the Art. 22(3) sterilizer.

For an Art. 22(1) procedure pack, follow Art. 22(5).

For an Art. 22(3) procedure pack, treat is as a device, so classify it under Annex VIII, determine the Art. 52 conformity assessment path, and implement that path.

Vigilance applies to the manufacturer only, none of the other five economic operators can make vigilance reports. The Art. 22(1) procedure pack, therefore is not subject to vigilance. However, the devices in the procedure pack are subject to vigilance. If the Art. 22(1) combiner were to receive a complaint, pass it immediately to the device manufacturer.

Good morning,

@Dan O'Leary I'm not sure if I understand correctly this interpretation of Art.22. This only confirms that there is no clear interpretation guide for Article 22.

For my understanding PPP can have the PP that meets Art.22 (1),(2) and (3) and still not follow the Art.52...means, without bear an additional CE marking on PP label.

If PPP has all components CE marked, he can create his  PP ​(Art.22 (1, 2)), sterilize (Art.22 (3)) and follow the Art.22 (5).

In the Art.22 (3) it is clearly stated that ..."application of those procedures  (Annex IX or Part A of Annex X) and the involvement of the notified body shall be limited to the aspects of the procedure relating to ensuring sterility until the sterile packaging is opened or damaged. The natural or legal person shall draw up a statement declaring that sterilisation has been carried out in accordance with the manufacturer's instructions".

For my understanding, if PPP needs to follow the component specific "manufacturer's instructions"  he can't be consider Manufacturer fully responsible as per Art.52. The PPP shall draw up a statement (formal, documented) to that effect. Alternatively, the manufacturer of component needs to confirm that the PPP sterilization parameters conform to those of the manufacturer.

PPP shall obtain certification for the sterilisation activities from a NB as per Art. 22 (3). If the responsibility of PPP is limited to the sterilization, also vigilance obligations should be limited to these aspects.

Usually, PPP has no knowledge to perform very deep root cause analysis if the incident is caused by specific CE marked component. It is obligation of component device manufacturer to follow Art.87 (bdw EUDAMED Vigilance module – VGL is available only for Manufacturers https://ec.europa.eu/health/sites/health/files/md_eudamed/docs/md_eudamed_fs_v4_1_en.pdf)
... The root cause of the incident may be with the manufacturer's device itself (component manufacturer's responsibility), or with the PPP's assembly of the PP i.e. with the  combination/configuration, processing/sterilisation etc. of the components of the pack => then the responsibility lies with the PPP.

I believe that there is not enough clarity on this topic...

Thank you again.

First, recognize that there four types of procedure pack. One type meets Art 22(1), while the other three are in Art. 22(4). The first type does not a CE Mark or NB involvement. The other three types are devices in their own right. They follow the Art. 52 conformity assessment and the natural or legal person is a manufacturer.

In all four cases the name of the natural or legal person is on the product. In the first case through Art. 22(5) and in the other cases through the manufacturer requirements.

For vigilance, Art. 87(1) applies to manufacturers, but not to any of the other five economic operators.

I find Article 22 straightforward and simple. However, there is a lot going on, so it is necessary to separate the activities. Also, I'm going to avoid PP, PPP, PPPP, ad infinitum because I think they mask the correct distinctions.

Start with the Art. 2(35) definition of economic operator. For this discussion, they are "the person referred to in Article 22(1) and 22(3)". The person in Art. 22(1) combines "devices bearing a CE marking with the following other devices or products …". The person in Art. 22(3) sterilizes Art. 22(1) procedure packs. In common practice one person combines and another person sterilizes. In other words, the person in Article 22(3) could be a contract sterilizer. The same person could have both roles. The Art. 22(3) sterilizer, requires Notified Body involvement for the sterilization aspects. The person who combines the Art. 22(1) procedure pack does not need Notified Body involvement. Some Art. 22(1) procedure packs require sterilization and some do not. Be careful to distinguish the roles.

There are, by my count, four types of procedure packs. One is from Art. 22(1) and three are from Art. 22(4).

For an Art. 22(1) procedure pack, the person prepares the Art. 22(22) statement, does not put CE Mark on the procedure pack, includes the Art. 22(1) combiner's identity, and includes the information from Annex I(23).

If the procedure pack is sterilized, then it also includes the Art. 22(3) sterilizer's identity.

For any of the Art. 22(4) procedure packs, it is a device in its own right, it follows the appropriate Article 52 conformity assessment procedure, and the natural or legal person assumes the obligations incumbent on manufacturers.

Here is my model for implementation.
Determine that the product is a procedure pack following the definition in Art. 2(10).

Classify the procedure pack as either Art. 22(1) or Art. 22(4).

Determine if the procedure pack requires sterilization and, if so, identify the Art. 22(3) sterilizer.

For an Art. 22(1) procedure pack, follow Art. 22(5).

For an Art. 22(3) procedure pack, treat is as a device, so classify it under Annex VIII, determine the Art. 52 conformity assessment path, and implement that path.

Vigilance applies to the manufacturer only, none of the other five economic operators can make vigilance reports. The Art. 22(1) procedure pack, therefore is not subject to vigilance. However, the devices in the procedure pack are subject to vigilance. If the Art. 22(1) combiner were to receive a complaint, pass it immediately to the device manufacturer.

Good morning,

@Dan O'Leary I'm not sure if I understand correctly this interpretation of Art.22. This only confirms that there is no clear interpretation guide for Article 22.

For my understanding PPP can have the PP that meets Art.22 (1),(2) and (3) and still not follow the Art.52...means, without bear an additional CE marking on PP label.

If PPP has all components CE marked, he can create his  PP ​(Art.22 (1, 2)), sterilize (Art.22 (3)) and follow the Art.22 (5).

In the Art.22 (3) it is clearly stated that ..."application of those procedures  (Annex IX or Part A of Annex X) and the involvement of the notified body shall be limited to the aspects of the procedure relating to ensuring sterility until the sterile packaging is opened or damaged. The natural or legal person shall draw up a statement declaring that sterilisation has been carried out in accordance with the manufacturer's instructions".

For my understanding, if PPP needs to follow the component specific "manufacturer's instructions"  he can't be consider Manufacturer fully responsible as per Art.52. The PPP shall draw up a statement (formal, documented) to that effect. Alternatively, the manufacturer of component needs to confirm that the PPP sterilization parameters conform to those of the manufacturer.

PPP shall obtain certification for the sterilisation activities from a NB as per Art. 22 (3). If the responsibility of PPP is limited to the sterilization, also vigilance obligations should be limited to these aspects.

Usually, PPP has no knowledge to perform very deep root cause analysis if the incident is caused by specific CE marked component. It is obligation of component device manufacturer to follow Art.87 (bdw EUDAMED Vigilance module – VGL is available only for Manufacturers https://ec.europa.eu/health/sites/health/files/md_eudamed/docs/md_eudamed_fs_v4_1_en.pdf)
... The root cause of the incident may be with the manufacturer's device itself (component manufacturer's responsibility), or with the PPP's assembly of the PP i.e. with the  combination/configuration, processing/sterilisation etc. of the components of the pack => then the responsibility lies with the PPP.

I believe that there is not enough clarity on this topic...

Thank you again.

First, recognize that there four types of procedure pack. One type meets Art 22(1), while the other three are in Art. 22(4). The first type does not a CE Mark or NB involvement. The other three types are devices in their own right. They follow the Art. 52 conformity assessment and the natural or legal person is a manufacturer.

In all four cases the name of the natural or legal person is on the product. In the first case through Art. 22(5) and in the other cases through the manufacturer requirements.

For vigilance, Art. 87(1) applies to manufacturers, but not to any of the other five economic operators.