Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

We recently had our CE certificate suspended, but are in the process of addressing the NC's in order to bring our product back into compliance. Prior to the suspension, we sold quite a bit of class IIa and class IIb medical devices to one of our distributors and now they are having a hard time selling the CE marked product even though it was still under compliance when he purchased the product. Is there anything we can provide to our distributor to show his customers the items were in compliance when he purchased them?

​Good morning

There is a very good interpretative document of the European Commission which provides good guidance (see attachment). This may be a good document to hand over to your distributor.

Some of the important sections for your case:

• Legal definition: "'placing on the market' means the first making available in return for payment or free of charge of a device […], with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished" (Article 1(2)(h) of Council Directive 93/42/EEC)
• Consequently, a finished medical device (even if it is put in the warehouse of the manufacturer) is not considered "placed on the market" because it is not sufficient for a product to be placed on the market (it lacks the "distribution piece")
• The Guide to the implementation of directives based on the New Approach and the Global Approach ("Blue Guide")  states that the placing on the market takes place when the product is transferred from the stage of manufacture with the intention of distribution or use on the Community market.
• The transfer can consist in a physical hand-over and/or be based on a legal transaction. It can relate to the ownership, the possession or any other right transferred from the manufacturer to a distributor or to the end user. A transfer of a product is considered to have taken place, e.g., when it is sold, leased, given as a gift, rent out or hired. Where a manufacture operates an own distinct distribution chain, the transfer can also occur to that distribution chain.
• In certain circumstances, a device which physically is still in the manufacturer's warehouse can be considered as placed on the market. For example, this may be the case where the ownership or another right of a certain product has already been transferred to either a distributor or the end user but the product is still stored by the manufacturer on their behalf. A case-by-case assessment is required and the manufacturer would have to be able to demonstrate that the product is singled out for being distributed.

Hope this helps!

Best regards
Beat

------------------------------
Beat U. Steffen
confinis ag
Founder & CEO
Düdingen
Switzerland
------------------------------

Original Message:
Sent: 11-Jun-2018 11:49
From: Anonymous Member
Subject: Suspended CE Certificate

This message was posted by a user wishing to remain anonymous

Hello,

We recently had our CE certificate suspended, but are in the process of addressing the NC's in order to bring our product back into compliance. Prior to the suspension, we sold quite a bit of class IIa and class IIb medical devices to one of our distributors and now they are having a hard time selling the CE marked product even though it was still under compliance when he purchased the product. Is there anything we can provide to our distributor to show his customers the items were in compliance when he purchased them?

Hire a good public relations firm ... while your products may have been legally able to be placed on the market a few weeks or months ago when you sold to the distributor originally, having a suspended certificate is perceived for all products.  No matter the time placed on the market.  Think about a consumer: if I see something posted about a product in the store, an electronic product I currently own, or any other CE Marked product, I would question whether my product is still "ok" to use if the manufacturers CE certificate was suspended.  Suggest also getting 'Ps and Qs' in order for whatever NCs you were issued because it is only going to get worse in the future.

------------------------------
Richard Vincins RAC
Vice President Regulatory Affairs
------------------------------

Original Message:
Sent: 12-Jun-2018 02:36
From: Beat Steffen
Subject: Suspended CE Certificate

​Good morning

There is a very good interpretative document of the European Commission which provides good guidance (see attachment). This may be a good document to hand over to your distributor.

Some of the important sections for your case:

• Legal definition: "'placing on the market' means the first making available in return for payment or free of charge of a device […], with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished" (Article 1(2)(h) of Council Directive 93/42/EEC)
• Consequently, a finished medical device (even if it is put in the warehouse of the manufacturer) is not considered "placed on the market" because it is not sufficient for a product to be placed on the market (it lacks the "distribution piece")
• The Guide to the implementation of directives based on the New Approach and the Global Approach ("Blue Guide")  states that the placing on the market takes place when the product is transferred from the stage of manufacture with the intention of distribution or use on the Community market.
• The transfer can consist in a physical hand-over and/or be based on a legal transaction. It can relate to the ownership, the possession or any other right transferred from the manufacturer to a distributor or to the end user. A transfer of a product is considered to have taken place, e.g., when it is sold, leased, given as a gift, rent out or hired. Where a manufacture operates an own distinct distribution chain, the transfer can also occur to that distribution chain.
• In certain circumstances, a device which physically is still in the manufacturer's warehouse can be considered as placed on the market. For example, this may be the case where the ownership or another right of a certain product has already been transferred to either a distributor or the end user but the product is still stored by the manufacturer on their behalf. A case-by-case assessment is required and the manufacturer would have to be able to demonstrate that the product is singled out for being distributed.

Hope this helps!

Best regards
Beat

------------------------------
Beat U. Steffen
confinis ag
Founder & CEO
Düdingen
Switzerland

Original Message:
Sent: 11-Jun-2018 11:49
From: Anonymous Member
Subject: Suspended CE Certificate

This message was posted by a user wishing to remain anonymous

Hello,

We recently had our CE certificate suspended, but are in the process of addressing the NC's in order to bring our product back into compliance. Prior to the suspension, we sold quite a bit of class IIa and class IIb medical devices to one of our distributors and now they are having a hard time selling the CE marked product even though it was still under compliance when he purchased the product. Is there anything we can provide to our distributor to show his customers the items were in compliance when he purchased them?