Regulatory Open Forum

Dear all,

I was wondering what are your thoughts on the following: Where a product is discontinued and it was under the scope of an EU authorised rep mandate (e.g. MDD CE cert is expired and we do not wish to move this product to MDR), should we terminate the agreement once CE is expired and how would you recommend terminating it? Or should we maintain this mandate "live" until the last lot that was placed on the market for that device has expired, and then terminate it?

Thank you!

In general, an expired EC certificate is not a proper rationale for terminating the EU authorised representative (AR) mandate.  This is because for example the AR still has obligations to the national competent authorities (NCA) regarding nonconforming devices still on the market.  Thus, something like your second option (maintain the mandate until the last marketed lot has expired) is a better type of approach.  The ultimate approach needs to be fashioned commensurate with risk, where higher risk devices may require more stringent or extended attention by the AR, or perhaps a recall rather than basing the termination on an expiration date.

Dear all,

I was wondering what are your thoughts on the following: Where a product is discontinued and it was under the scope of an EU authorised rep mandate (e.g. MDD CE cert is expired and we do not wish to move this product to MDR), should we terminate the agreement once CE is expired and how would you recommend terminating it? Or should we maintain this mandate "live" until the last lot that was placed on the market for that device has expired, and then terminate it?

Thank you!

Good day Anon,

Recommend establishing an "end of life" protocol or plan for the product which is CE Marked under the EU MDD and which is not going to transition to EU MDR.  In fact, an End of Life Plan for any product being removed from the market would be necessary to define how activities occur such as inventory, distribution, Agreements, complaint handling, cancelling the Declaration of Conformity (DofC), etc.  If a product say has an expiration date of two (2) years, then the product is cancelled end of 2025, there would still be products "in service" within the European Market till end of 2027.  You and the Authorised Representative still have obligations under the EU MDD for compliance and reporting of the product until the end of 2027.  What might change is content of the Mandate (or commonly called the Authorised Representative Agreement) to clearly define what is happening in this two year period of the inventory until depleted.  In my experience, most companies do nothing to their current Agreement/Mandate or make a small change in the product listing saying 'X' product has been discontinued with an end date.  Now if the company has a durable product which has a usable life of many years, then the Agreement/Mandate between the two parties might need to change to only focusing on the post market reporting aspects, e.g. reportable events or field safety corrective actions.

In general, an expired EC certificate is not a proper rationale for terminating the EU authorised representative (AR) mandate.  This is because for example the AR still has obligations to the national competent authorities (NCA) regarding nonconforming devices still on the market.  Thus, something like your second option (maintain the mandate until the last marketed lot has expired) is a better type of approach.  The ultimate approach needs to be fashioned commensurate with risk, where higher risk devices may require more stringent or extended attention by the AR, or perhaps a recall rather than basing the termination on an expiration date.

Dear all,

I was wondering what are your thoughts on the following: Where a product is discontinued and it was under the scope of an EU authorised rep mandate (e.g. MDD CE cert is expired and we do not wish to move this product to MDR), should we terminate the agreement once CE is expired and how would you recommend terminating it? Or should we maintain this mandate "live" until the last lot that was placed on the market for that device has expired, and then terminate it?

Thank you!

In general, an expired EC certificate is not a proper rationale for terminating the EU authorised representative (AR) mandate.  This is because for example the AR still has obligations to the national competent authorities (NCA) regarding nonconforming devices still on the market.  Thus, something like your second option (maintain the mandate until the last marketed lot has expired) is a better type of approach.  The ultimate approach needs to be fashioned commensurate with risk, where higher risk devices may require more stringent or extended attention by the AR, or perhaps a recall rather than basing the termination on an expiration date.

Dear all,

I was wondering what are your thoughts on the following: Where a product is discontinued and it was under the scope of an EU authorised rep mandate (e.g. MDD CE cert is expired and we do not wish to move this product to MDR), should we terminate the agreement once CE is expired and how would you recommend terminating it? Or should we maintain this mandate "live" until the last lot that was placed on the market for that device has expired, and then terminate it?

Thank you!