From 13 December 2024, the EU Regulation on General Product Safety 2023/988 (GPSR) applies in European Union (EU) Member States. Please visit the Europa website for full details of the regulation. For products regulated by the GPSR to be placed on the EU market, there must be a responsible economic operator or authorised representative in place.

Due to Brexit and the end of the UK’s post-Brexit transition period many UK small businesses are ceasing selling to the EU as the requirements will make trade unviable. However, we will continue to supply all our products to our European distributors. This does not affect sales worldwide.

Unfortunately for us, we will no longer offer direct sales to EU states where we don’t have representation. Instead we’ll ask buyers from those EU states to contact one of our authorised EU representatives.

As importers of our products into the EU, distributors can act as authorised representatives, fulfilling the requirements of article 16 of the GPSR. This does place certain obligations on Cantium Scientific Limited as the manufacturer, and our distributors as authorised representatives. In summary…

Distributor obligations as an Authorised Representative

Article 16.1

Cantium Scientific Limited will continue to support distributors with all information needed in relation to their requirements under Article 4(3) of Regulation (EU) 2019/1020 for market surveillance and compliance of products.

Article 16.2

The authorised representative must

a) check the product complies with manufacturer’s documentation under article 9(2) (see below);

b) check the product complies with requirements in article 9(5) (see below).

To support this, every product (excluding spare parts) is factory calibrated and supplied with a certificate. Every product has full traceability.

Article 16.3

The distributor (authorised representative) name needs to be on the product or product packaging. The MB2 already displays the distributor name (for EU and some other states) on its screen at start-up. We will modify our packaging labels to show your name. This will be done for distributors worldwide, not just EU.

Cantium Scientific Limited’s obligations as a Manufacturer

Articles 9(1) to 9(4)

All Cantium Scientific Limited’s products are designed and manufactured to comply with existing and new versions of the GPSR requirements, meeting all relevant technical standards. We keep documentation in accordance with the GPSR and are working to make this available online to our distributors.

Article 9(5)

Product serial numbers includes the product article number, lot number and sequential number so that it can be traced to date of manufacture, manufacturing processes and persons, place of manufacture, individual components and raw materials used with details of suppliers and origins for those materials. Spare parts that cannot be marked with a serial number are traceable to source materials and manufacture via lot numbers that will be shown on delivery notes. We use a Manufacturing Resource Planning (MRP) system to manage all purchasing, materials processing, manufacturing, quality control and sales, linking all information together.

Article 9(6)

Our company details are contained on the product packaging and documentation that accompanies the products.

Article 9(7)

We provide a printed instruction manual in English, but will be moving this to an online multi-lingual manual in the near future. Full printed manuals in English will be available if required.

Article 9(8) to 9(10)

This is covered by our existing MRP system’s traceability features and QMS Product Recall procedures. We do not sell our products to consumer markets, so recalls are normally handled via distributors. If appropriate, we will additionally use the Safety Business Gateway.

Article 9(11)

For users of our products to communicate issues, provisions are already available on our website and our technical support portal.

Article 9(12)

Investigation of any product issue is covered by our existing QMS procedures. Details of our procedures are available upon request.

Article 9(13)

Information is kept confidential in accordance with GDPR requirements. We are registered in the UK with the Information Commissioners Office as a data controller, registration number: Z8296383. Our certification is available upon request.