Regulatory Open Forum

Hi All,
I am wondering if someone can please shed light on the (mandatory) request by EU Importer that the UK Manufacturer's insurer should include the EU Importer as "additional insured" to cover any product liabilities in relation to the activities of the importer on behalf of the UK manufacturer in the EU? Is this the norm and any idea how this can be achieved particularly if manufacturer's insurer is reluctant to provide the cover?
Many thanks for your insight.
Abi.

------------------------------
Abi Bamigbade
Head of Quality and Regulatory Affairs
Kays Medical Ltd, UK.
------------------------------

Well it's not a requirement for starters. The importer for MDR / IVDR may well also qualify as the first reseller in the EU for the purpose of the Product Liability Directive (PLD), in which case they are product liable for defects causing damage in the EU (since the manufacturer (who may or may not be producer in the meaning of the PLD) is not in the EU. So in that light the importer definately would want this because just a contractual indemnity is not as good as being additional insured.
In my experience adding the EU importer as additional insured is certainly not the norm in international distribution agreements although I can see why the importer would ask for this.
If the manufacturer insurance is reluctant to provide the cover: not suprised because they are reluctant about anything that does not fit generally outdated risk perception. And usually they're also reluctant relative to how much premium increase they can ask. You could consider sharing the increased costs with the importer in exchange for better protection on their side. It is a costly ask from them after all.

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands
------------------------------

Original Message:
Sent: 19-May-2022 11:30
From: Abiola Bamigbade
Subject: Product Liability Insurance coverage for EU Importer by UK Manufacturer

Hi All,
I am wondering if someone can please shed light on the (mandatory) request by EU Importer that the UK Manufacturer's insurer should include the EU Importer as "additional insured" to cover any product liabilities in relation to the activities of the importer on behalf of the UK manufacturer in the EU? Is this the norm and any idea how this can be achieved particularly if manufacturer's insurer is reluctant to provide the cover?
Many thanks for your insight.
Abi.

------------------------------
Abi Bamigbade
Head of Quality and Regulatory Affairs
Kays Medical Ltd, UK.
------------------------------

Thanks Erik for the response.
The way around it that was found was about the change of text, in agreement with the insurance underwriters; added the EU Importers as "Interested Parties" under the product liability cover, rather than "additional insureds". #win-win!​

------------------------------
Abi Bamigbade
Head of Quality and Regulatory Affairs
Kays Medical Ltd, UK.
------------------------------

Original Message:
Sent: 20-May-2022 02:28
From: Erik Vollebregt
Subject: Product Liability Insurance coverage for EU Importer by UK Manufacturer

Well it's not a requirement for starters. The importer for MDR / IVDR may well also qualify as the first reseller in the EU for the purpose of the Product Liability Directive (PLD), in which case they are product liable for defects causing damage in the EU (since the manufacturer (who may or may not be producer in the meaning of the PLD) is not in the EU. So in that light the importer definately would want this because just a contractual indemnity is not as good as being additional insured.
In my experience adding the EU importer as additional insured is certainly not the norm in international distribution agreements although I can see why the importer would ask for this.
If the manufacturer insurance is reluctant to provide the cover: not suprised because they are reluctant about anything that does not fit generally outdated risk perception. And usually they're also reluctant relative to how much premium increase they can ask. You could consider sharing the increased costs with the importer in exchange for better protection on their side. It is a costly ask from them after all.

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands

Original Message:
Sent: 19-May-2022 11:30
From: Abiola Bamigbade
Subject: Product Liability Insurance coverage for EU Importer by UK Manufacturer

Hi All,
I am wondering if someone can please shed light on the (mandatory) request by EU Importer that the UK Manufacturer's insurer should include the EU Importer as "additional insured" to cover any product liabilities in relation to the activities of the importer on behalf of the UK manufacturer in the EU? Is this the norm and any idea how this can be achieved particularly if manufacturer's insurer is reluctant to provide the cover?
Many thanks for your insight.
Abi.

------------------------------
Abi Bamigbade
Head of Quality and Regulatory Affairs
Kays Medical Ltd, UK.
------------------------------

That's certainy a win for you if the importer accepted that, because an interested party is not an insured party but only a party kept informed about the status of your insurance cover. Did the importer ask for additional indemnification language in the agreement with the manufacturer?

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands
------------------------------

Original Message:
Sent: 26-May-2022 10:11
From: Abiola Bamigbade
Subject: Product Liability Insurance coverage for EU Importer by UK Manufacturer

Thanks Erik for the response.
The way around it that was found was about the change of text, in agreement with the insurance underwriters; added the EU Importers as "Interested Parties" under the product liability cover, rather than "additional insureds". #win-win!​

------------------------------
Abi Bamigbade
Head of Quality and Regulatory Affairs
Kays Medical Ltd, UK.

Original Message:
Sent: 20-May-2022 02:28
From: Erik Vollebregt
Subject: Product Liability Insurance coverage for EU Importer by UK Manufacturer

Well it's not a requirement for starters. The importer for MDR / IVDR may well also qualify as the first reseller in the EU for the purpose of the Product Liability Directive (PLD), in which case they are product liable for defects causing damage in the EU (since the manufacturer (who may or may not be producer in the meaning of the PLD) is not in the EU. So in that light the importer definately would want this because just a contractual indemnity is not as good as being additional insured.
In my experience adding the EU importer as additional insured is certainly not the norm in international distribution agreements although I can see why the importer would ask for this.
If the manufacturer insurance is reluctant to provide the cover: not suprised because they are reluctant about anything that does not fit generally outdated risk perception. And usually they're also reluctant relative to how much premium increase they can ask. You could consider sharing the increased costs with the importer in exchange for better protection on their side. It is a costly ask from them after all.

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands

Original Message:
Sent: 19-May-2022 11:30
From: Abiola Bamigbade
Subject: Product Liability Insurance coverage for EU Importer by UK Manufacturer

Hi All,
I am wondering if someone can please shed light on the (mandatory) request by EU Importer that the UK Manufacturer's insurer should include the EU Importer as "additional insured" to cover any product liabilities in relation to the activities of the importer on behalf of the UK manufacturer in the EU? Is this the norm and any idea how this can be achieved particularly if manufacturer's insurer is reluctant to provide the cover?
Many thanks for your insight.
Abi.

------------------------------
Abi Bamigbade
Head of Quality and Regulatory Affairs
Kays Medical Ltd, UK.
------------------------------