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controlz
Hi All,
We are a seller of first aid kits across the UK and EU. Our bags and components are manufactured in China, but since we are selling the kit under our own brand, we are a registered assembler with the MHRA.
As part of our due diligence, we are looking to seek advice from an expert who is able to assess our documents, component labelling and confirm overall compliance with the Medical Devices Directive. if there are any gaps, we want guidance on how to resolve these as quickly as possible. If anybody has any contacts or recommendations of somebody/a firm that could help, I would appreciate being put in touch.
I also have some more general queries that I hope you may be able to help with:
1. If we are a registered UK assembler, does this void the need for an EU representative?
2. If not, which components need to be marked with EU representative address (e.g. all components or sterile only) and which require only the Chinese manufacturer's address?
3. Does the overall kit require a printed instruction manual if each individual component has instructions printed on it?
4. Must the instructions be written in every European language the kit is sold in, or is English acceptable?
Many thanks
We are a seller of first aid kits across the UK and EU. Our bags and components are manufactured in China, but since we are selling the kit under our own brand, we are a registered assembler with the MHRA.
As part of our due diligence, we are looking to seek advice from an expert who is able to assess our documents, component labelling and confirm overall compliance with the Medical Devices Directive. if there are any gaps, we want guidance on how to resolve these as quickly as possible. If anybody has any contacts or recommendations of somebody/a firm that could help, I would appreciate being put in touch.
I also have some more general queries that I hope you may be able to help with:
1. If we are a registered UK assembler, does this void the need for an EU representative?
2. If not, which components need to be marked with EU representative address (e.g. all components or sterile only) and which require only the Chinese manufacturer's address?
3. Does the overall kit require a printed instruction manual if each individual component has instructions printed on it?
4. Must the instructions be written in every European language the kit is sold in, or is English acceptable?
Many thanks