Hi all, I was hoping to get your thoughts on the definition of a distributor under MDR and how that relates to the definition of a 'distributor' vs 'fulfilment service provider' in terms of the Market Surveillance Regulation EU 2019/1020 (MSR)?
We are currently using the services of a company to warehouse and pick, pack & ship product for us on the continent. Per the MDR I believe that this company meets the definition of a distributor i.e. they are a part of the supply chain that makes medical devices available on the market. This company however is wanting to reclassify themselves as a 'fulfilment service provider' as defined in the MSR.
As I understand it, this company wanting to call themselves a 'fulfilment service provider' under a different regulation has no bearing on the fact that they are a 'distributor' as defined in the MDR, and therefore obliged to meet all of the obligations of a distributor as defined in the MDR.
Furthermore, MSR (4) states "However, in accordance with the principle of lex specialis, this Regulation should apply only in so far as there are no specific provisions with the same objective, nature or effect in Union harmonisation legislation. The corresponding provisions of this Regulation should therefore not apply in the areas covered by such specific provisions, for instance those set out in Regulations (EC) No 1223/2009 ( 3 ), (EU) 2017/745 ( 4 ) and (EU) 2017/746 ( 5 ), including as regards the use of the European database on medical devices (EUDAMED), and (EU) 2018/858 ( 6 ) of the European Parliament and of the Council".
Doesn't this mean that the provisions of the MDR trump any provisions of the MSR?
If there's anyone out there who has had experience with this I'd love to hear your thoughts.
Thanks so much.
L
We are currently using the services of a company to warehouse and pick, pack & ship product for us on the continent. Per the MDR I believe that this company meets the definition of a distributor i.e. they are a part of the supply chain that makes medical devices available on the market. This company however is wanting to reclassify themselves as a 'fulfilment service provider' as defined in the MSR.
As I understand it, this company wanting to call themselves a 'fulfilment service provider' under a different regulation has no bearing on the fact that they are a 'distributor' as defined in the MDR, and therefore obliged to meet all of the obligations of a distributor as defined in the MDR.
Furthermore, MSR (4) states "However, in accordance with the principle of lex specialis, this Regulation should apply only in so far as there are no specific provisions with the same objective, nature or effect in Union harmonisation legislation. The corresponding provisions of this Regulation should therefore not apply in the areas covered by such specific provisions, for instance those set out in Regulations (EC) No 1223/2009 ( 3 ), (EU) 2017/745 ( 4 ) and (EU) 2017/746 ( 5 ), including as regards the use of the European database on medical devices (EUDAMED), and (EU) 2018/858 ( 6 ) of the European Parliament and of the Council".
Doesn't this mean that the provisions of the MDR trump any provisions of the MSR?
If there's anyone out there who has had experience with this I'd love to hear your thoughts.
Thanks so much.
L