Distributor control for MDR / ISO 13485 / MDSAP

[Ed Panek]

Your sales channel for one. A sudden loss of a distributor could cost a lot of $.

An agreement could augment that but since we already have a system to check on the performance of a partner I’d be ok using it however the MDR does not prescribe any type of relationship. Agreed.

 

[TorstenKn]

I always enjoy discussions about the role of distributors. Being based in Germany, I often pose the following question: Assume the manufacturer sells directly to public pharmacies, which are clearly acting as distributors. We have around 17,000 pharmacies in Germany. Would an auditor now expect you to establish up to 17,000 agreements, conduct up to 17,000 audits, etc.? And if these pharmacies were considered critical subcontractors, would they really expect to audit all of them? Clearly not.

One of the newer aspects of the MDR is that distributors now have a distinct role with legal responsibilities. However, this does not mean they require additional control beyond their standard duties.

There is one exception: if certain tasks, such as complaint processing, training, or maintenance, are delegated to your distributor, then the situation changes. In such cases, I believe it’s important to differentiate between roles. If you outsource any activities to your distributor, they are performing distribution in one role and providing services in another. These roles should be treated separately.

 

[QuinnM]

In our QMS distributors are part of the supply chain because they provide a service. As explained from others above.

 

[SeanN]

it was mentioned that under MDR, distributors may need to be treated as critical suppliers. Could you please confirm if there is a specific regulatory section addressing this requirement?

Additionally, how do other standards like ISO 13485 and MDSAP view the control and management of distributors?

I do not know your products and any special requirements about preservation.

For example, 7.5.9.2 Implantable "... The organization shall require that suppliers of distribution services or distributors maintain records of the distribution of medical devices to allow traceability and that these records are available for inspection." or 7.5.11 "The organization shall document procedures for preserving the conformity of product to requirements during processing, storage, handling, and distribution. The organization shall protect product from alteration, contamination or damage when exposed to expected conditions and hazards during processing, storage, handling, and distribution", and more.

In my opinion, there is nothing wrong when your auditor says "distributors may need to be treated as critical suppliers", and not like what you wrote in your second post ("but he said it has to be critical supplier"). Imagine your product is an IVD reagent which needs to be preserved at -80C. it would be totally different from TorstenKn's example, and not many distributors can meet this requirement. In this case, your distributor is a critical supplier. More accurately, they are a critical quality partner and your QMS has to address this. There is nothing wrong with the wrote "critical" because it's about the level of risk involved. There may be no need for you to find a specific paragraph in certain regulations unless the auditor gives you an NC. If it's the case, s/he will give you the paragraph.

 

[Ed Panek]

I always enjoy discussions about the role of distributors. Being based in Germany, I often pose the following question: Assume the manufacturer sells directly to public pharmacies, which are clearly acting as distributors. We have around 17,000 pharmacies in Germany. Would an auditor now expect you to establish up to 17,000 agreements, conduct up to 17,000 audits, etc.? And if these pharmacies were considered critical subcontractors, would they really expect to audit all of them? Clearly not.

One of the newer aspects of the MDR is that distributors now have a distinct role with legal responsibilities. However, this does not mean they require additional control beyond their standard duties.

There is one exception: if certain tasks, such as complaint processing, training, or maintenance, are delegated to your distributor, then the situation changes. In such cases, I believe it’s important to differentiate between roles. If you outsource any activities to your distributor, they are performing distribution in one role and providing services in another. These roles should be treated separately.

Curious what would a competent authority do in the event of the following: A distributor has not controlled the environment for device storage and has received number complaints on the product but failed to act on them or forward them to the manufacturer.

As the manufacturer I would be very upset. With my next distributor we would make sure we check their performance ongoing. An audit would be a suitable format to check them.

 

[Ronen E]

I always enjoy discussions about the role of distributors. Being based in Germany, I often pose the following question: Assume the manufacturer sells directly to public pharmacies, which are clearly acting as distributors. We have around 17,000 pharmacies in Germany. Would an auditor now expect you to establish up to 17,000 agreements, conduct up to 17,000 audits, etc.? And if these pharmacies were considered critical subcontractors, would they really expect to audit all of them? Clearly not.

One of the newer aspects of the MDR is that distributors now have a distinct role with legal responsibilities. However, this does not mean they require additional control beyond their standard duties.

There is one exception: if certain tasks, such as complaint processing, training, or maintenance, are delegated to your distributor, then the situation changes. In such cases, I believe it’s important to differentiate between roles. If you outsource any activities to your distributor, they are performing distribution in one role and providing services in another. These roles should be treated separately.

Bravo!!!

 

[Ronen E]

failed to act on them or forward them to the manufacturer.

As the manufacturer I would be very upset.

If these led (or could have led) to serious medical outcomes you'd have been informed through other channels, as there are reporting obligations other than the distributor's.

An audit would be a suitable format to check them.

As above, what if you had thousands of distributors? Would you go out and audit all of them as part of your corrective action? Or "just" every new distributor from now on?

A more measured response would be to fully investigate what happened and THEN decide what corrective action is called for. You have to understand the circumstances and factors that led to the failure if you want to be effective about preventing recurrence.

 

[Ed Panek]

If these led (or could have led) to serious medical outcomes you'd have been informed through other channels, as there are reporting obligations other than the distributor's.

As above, what if you had thousands of distributors? Would you go out and audit all of them as part of your corrective action? Or "just" every new distributor from now on?

A more measured response would be to fully investigate what happened and THEN decide what corrective action is called for. You have to understand the circumstances and factors that led to the failure if you want to be effective about preventing recurrence.

After the fact is too late. I suggest being proactive and not waiting till it falls apart to investigate

If you have thousands of distributors this may not be feasible. But if you have a few it’s possible

This explains my perspective. Medical device manufacturers: control your supply chain for MDR and IVDR requirements

And here.

Strategies for managing regulatory risk with third-party distributors

In today@s global healthcare distribution market, an increasing number of medical device and in vitro diagnostic medical device (IVD) companies are aspiring to market globally. One of the main challenges these manufacturers face is how to register and distribute their products internationally...

www.raps.org

 

[Edward Reesor]

It was suggested that we should evaluate our distributors as suppliers so we use the same paperwork as the "traditional" suppliers, and mention them as a line item in our management meetings. Once I even added the auditing body as a critical supplier (using the same logic), but was told that it wasn't necessary.

 

[Ronen E]

It was suggested that we should evaluate our distributors as suppliers so we use the same paperwork as the "traditional" suppliers, and mention them as a line item in our management meetings. Once I even added the auditing body as a critical supplier (using the same logic), but was told that it wasn't necessary.

Who told you it "wasn't necessary"? The auditing body?

The auditing body IS a supplier - you pay them and in return they provide a service (auditing).

Regarding "Critical", it's typical to have no clarity or consistency. I once applied a NB's written definitions and came up with a list of several suppliers, only to be told by the account leader that none of them were "critical", except the EU rep. No rationale was provided. It was one of the leading NBs.