Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear community,

this is an open question regarding the interpretation of Article 22 of the MDR and more in particular the 22(3). See below a case study and thx in advance for you comments and thoughts.

I'm the Legal Manufacturer of a Class III, Sterile Medical Device (MD-A). For the conformity assessment, i've validated my device for 1-year Shelf-Life after 1x Cycle of Sterilization (Gamma irradiation). My device is CE-mark per EU MDR. I've been approached by a Procedure Pack Producer (PPP), because they are willing to place my device (MD-A) as part of a Procedure Pack, with other medical devices. All other medical devices are also CE-marked.

The PPP is willing to Sterilize the Procedure Pack (meaning double sterilization for my device MD-A). Per MDR 22(3) the PPP shall draw-up a statement declaring that sterilsation has been carried out in accordance with the manufacturer's instructions. 

Questions:

Q1) If, as the Legal manufacturer of MD-A, I'm NOT providing the sterilisation details/ instructions/ specifications of my medical device to the PPP, can the PPP apply Article 22(3)?  or the Procedure Pack manufacturer should follow Art 52, as my device will be "double sterilized" following their validated sterilization process and parameters?

Q2) If i'm willing to provide the sterilsation instructions/ specs/ of my device (MD-A) to the PPP and the PPP is willing to sterilise the whole procedure pack (total 2 sterilization cycles), Am I (as the legal manufacturer of MD-A) responsible to "validate the dual sterilization" and shelf life before placing the device as part of the Procedure Pack? 

Thanks in advance for your thoughts.

BR

Q1: As I understand it, if the Article 22 Procedure Pack Producer (PPP) doesn't carry out the sterilization in accordance with the Procedure Pack (PP) constituent device manufacturer's instructions, then the PPP is not allowed to apply Article 22(3).  A key reason for this is that, without consulting the manufacturer(s) of the PP constituent device(s) and thereby not following the constituent device manufacturer's sterilization instructions, the constituent device integrity or other constituent device GSPR conformity could be adversely affected.  This is because the Article 22(3) route doesn't involve assuring full GSPR conformity of the PP constituents.  Instead, the Article 22(3) route and the PPP's corresponding Annex IX or XI conformity assessments made thereunder are for the procedure pack as a whole and limited only to assuring sterility.  Thus, while a PPP's Article 22(3) route may indeed assure sterility, it doesn't involve assuring the maintenance of various other GSPR requirements (e.g., constituent device stability/reliability, constituent device performance, constituent device labeling integrity/readability, etc.) for the resterilized PP constituent devices.

Q2) The reason the Article 22(3) route allows an abbreviated conformity assessment (focusing only on sterility) is because it is presumed that the PP constituent device manufacturers have assured that the full GSPR conformity of their constituent device(s) will be maintained upon repeated sterilization.  If the constituent device manufacturers don't provide such assurance, then it leaves a profound gap in GSPR conformity assurance of the PP's constituent devices.  Thus, either the constituent device manufacturers must fill that gap in support of the PPP's Article 22(3) route, or else the PPP is required to instead apply Article 22(4) so as to assure full GSPR conformity of the Procedure Pack and all of its constituents by applying a full Article 52 conformity assessment that is not limited to just sterility. 

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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 06-Feb-2024 05:00
From: Anonymous Member
Subject: Procedure Pack Producer & Article 22 MDR.

This message was posted by a user wishing to remain anonymous

Dear community,

this is an open question regarding the interpretation of Article 22 of the MDR and more in particular the 22(3). See below a case study and thx in advance for you comments and thoughts.

I'm the Legal Manufacturer of a Class III, Sterile Medical Device (MD-A). For the conformity assessment, i've validated my device for 1-year Shelf-Life after 1x Cycle of Sterilization (Gamma irradiation). My device is CE-mark per EU MDR. I've been approached by a Procedure Pack Producer (PPP), because they are willing to place my device (MD-A) as part of a Procedure Pack, with other medical devices. All other medical devices are also CE-marked.

The PPP is willing to Sterilize the Procedure Pack (meaning double sterilization for my device MD-A). Per MDR 22(3) the PPP shall draw-up a statement declaring that sterilsation has been carried out in accordance with the manufacturer's instructions. 

Questions:

Q1) If, as the Legal manufacturer of MD-A, I'm NOT providing the sterilisation details/ instructions/ specifications of my medical device to the PPP, can the PPP apply Article 22(3)?  or the Procedure Pack manufacturer should follow Art 52, as my device will be "double sterilized" following their validated sterilization process and parameters?

Q2) If i'm willing to provide the sterilsation instructions/ specs/ of my device (MD-A) to the PPP and the PPP is willing to sterilise the whole procedure pack (total 2 sterilization cycles), Am I (as the legal manufacturer of MD-A) responsible to "validate the dual sterilization" and shelf life before placing the device as part of the Procedure Pack? 

Thanks in advance for your thoughts.

BR

I agree with Kevin Randall that the PPP cannot sterilize the Class III device, unless you, the manufacturer, take specific measures. You can tell the PPP that their use of your device is not according to the manufacturing procedure and therefore not allowed. However, if you want to sell your device, you may have to become a bit more creative. I see two options:

1. You verify that the sterilization procedure of the PPP does not affect the quality of your device AND adds prolongued shelf life to your device. This may require additional certification testing.
2. You supply your device unsterilized and you make sure the sterilization is done according to your own process. In that way, you will outsource the sterilization to this PPP. However, this will bring their sterilization process under the scope of your quality management system. This may at least require additional auditing by the notified body. 

Maybe someone else in our community has other suggetions.

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Ronald Boumans
MDR Expert
Super PRRC
Netherlands
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Original Message:
Sent: 06-Feb-2024 05:00
From: Anonymous Member
Subject: Procedure Pack Producer & Article 22 MDR.

This message was posted by a user wishing to remain anonymous

Dear community,

this is an open question regarding the interpretation of Article 22 of the MDR and more in particular the 22(3). See below a case study and thx in advance for you comments and thoughts.

I'm the Legal Manufacturer of a Class III, Sterile Medical Device (MD-A). For the conformity assessment, i've validated my device for 1-year Shelf-Life after 1x Cycle of Sterilization (Gamma irradiation). My device is CE-mark per EU MDR. I've been approached by a Procedure Pack Producer (PPP), because they are willing to place my device (MD-A) as part of a Procedure Pack, with other medical devices. All other medical devices are also CE-marked.

The PPP is willing to Sterilize the Procedure Pack (meaning double sterilization for my device MD-A). Per MDR 22(3) the PPP shall draw-up a statement declaring that sterilsation has been carried out in accordance with the manufacturer's instructions. 

Questions:

Q1) If, as the Legal manufacturer of MD-A, I'm NOT providing the sterilisation details/ instructions/ specifications of my medical device to the PPP, can the PPP apply Article 22(3)?  or the Procedure Pack manufacturer should follow Art 52, as my device will be "double sterilized" following their validated sterilization process and parameters?

Q2) If i'm willing to provide the sterilsation instructions/ specs/ of my device (MD-A) to the PPP and the PPP is willing to sterilise the whole procedure pack (total 2 sterilization cycles), Am I (as the legal manufacturer of MD-A) responsible to "validate the dual sterilization" and shelf life before placing the device as part of the Procedure Pack? 

Thanks in advance for your thoughts.

BR

Hi Anon,

I agree with Kevin in Ronald: To avoid a full conformity assessment Article 22 assumes that the device (or product) is used "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 consequence the manufacturer must have considered the (additional) sterilization of the device within its conformity assessment.

With respect to the scenarios Ronald mentions:

I think scenario 1 works as described. The manufacturer makes the additional sterilization of the finished device part of its intended purpose and prescribes how this needs to be done and what consequences this might have with respect to shelf life.

I think scenario 2 does not work if you consider the sterilization process as an outsourced manufacturing step of the manufacturer: In this case the PPP would not handle a finished device (since it is missing the final sterilization), but would be part of the manufacturing process and the resulting procedure pack would be the fnished device (which as far as I can see does not work because it contains additional devices). For this to work the manufacturer would in my opinion have to change the status and intended purpose of the device in a way that the finished device is delivered non-sterile and meant to be sterilized by the user in a specified way (that could include integrating it into a sterile procedure pack). I think this would be closer to the scenario that this part of Article 22 is aimed at: You have devices that are meant to be sterilized by the user in a validated procedure (prescribed by the manufacturer and for the specific case validated by the end user, e.g. reusable surgical instruments, or non-sterile implants) and these are combined into a procedure pack for a defined surgical procedure by a third party, sterilized accordingly and then delivered to e.g. a hospital ready for use.

Both options would include changes that are significant and would as far as I can see require a review and an approval by the NB.

A third option might be to split the procedure pack into a part that is sterilized by the PPP (in accordance with the intended purpose of the included individual devices) and add the sterile class III device in a second step without the additional sterilization to form the final procedure pack. In this case no changes to the class III device would be required (assuming that the original packaging is maintained. If the device is repackaged in some way this would either have to be already be considered by the manufacturer or could maybe be done in a way that is compatible with Article 16's requirements for repackaging).

Best regards, Christoph

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Christoph Kiesselbach
Schrack & Partner
Reutlingen
Germany
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Original Message:
Sent: 06-Feb-2024 05:00
From: Anonymous Member
Subject: Procedure Pack Producer & Article 22 MDR.

This message was posted by a user wishing to remain anonymous

Dear community,

this is an open question regarding the interpretation of Article 22 of the MDR and more in particular the 22(3). See below a case study and thx in advance for you comments and thoughts.

I'm the Legal Manufacturer of a Class III, Sterile Medical Device (MD-A). For the conformity assessment, i've validated my device for 1-year Shelf-Life after 1x Cycle of Sterilization (Gamma irradiation). My device is CE-mark per EU MDR. I've been approached by a Procedure Pack Producer (PPP), because they are willing to place my device (MD-A) as part of a Procedure Pack, with other medical devices. All other medical devices are also CE-marked.

The PPP is willing to Sterilize the Procedure Pack (meaning double sterilization for my device MD-A). Per MDR 22(3) the PPP shall draw-up a statement declaring that sterilsation has been carried out in accordance with the manufacturer's instructions. 

Questions:

Q1) If, as the Legal manufacturer of MD-A, I'm NOT providing the sterilisation details/ instructions/ specifications of my medical device to the PPP, can the PPP apply Article 22(3)?  or the Procedure Pack manufacturer should follow Art 52, as my device will be "double sterilized" following their validated sterilization process and parameters?

Q2) If i'm willing to provide the sterilsation instructions/ specs/ of my device (MD-A) to the PPP and the PPP is willing to sterilise the whole procedure pack (total 2 sterilization cycles), Am I (as the legal manufacturer of MD-A) responsible to "validate the dual sterilization" and shelf life before placing the device as part of the Procedure Pack? 

Thanks in advance for your thoughts.

BR