First Aid Kit Compliance advice - Registered assembler with the MHRA

controlz

Starting to get Involved
#1
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
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
Hi,

I'd be glad to assess your situation and provide the advice you're looking for. Please send me a private message and we'll take it from there.

To your questions:

1. If we are a registered UK assembler, does this void the need for an EU representative?
Yes, until Brexit takes place.

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?
See #1. In principle there's no requirement for addresses on the components. With you being the official Manufacturer (for MDD purposes), your address is required on the kit as a whole. The Chinese adress is not required on the product, and it's also not forbidden as long as it's clear that their address is just a manufacturing site and you are in fact the responsible Manufacturer.

3. Does the overall kit require a printed instruction manual if each individual component has instructions printed on it?
Maybe not. It needs a more detailed review.

4. Must the instructions be written in every European language the kit is sold in, or is English acceptable?
In principle yes, but again it needs a careful, detailed review of the specifics. The official requirement is for an official EU language (an official language of an EU member state) that is acceptable to the state in which the device is made available ("sold").

General note: Please take into account that by 26 May 2020 most of the MDR (new EU regulation) will come into force, and most of the MDD will become superseded. There is some overlap but in some aspects the MDR is more demanding, so it may be a good idea to start building up towards the change-over rather than leaving it to the last moment.

Cheers,
Ronen.
 
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