EU Authorised Representative (MDR)

Last updated: 18 May 2026.

This page identifies the EU Authorised Representative for medical device products sold by Toolsmith Ltd into the European Union, as required by EU Regulation 2017/745 (Medical Device Regulation, "MDR"), Articles 11 and 13.

EU Authorised Representative

Name: Pik Pak Industries via IBC Sweden

Authorised representative registration: IBC 02502141A

Validity: 13 February 2026 to 12 February 2027

Scope: Acts as Authorised Representative for medical-device-adjacent precision instruments (dental, surgical, ophthalmic and veterinary instruments) supplied by Toolsmith Ltd, in line with EU MDR 2017/745 and (where applicable) UK MDR 2002 + Northern Ireland Protocol arrangements.

Manufacturer

Manufacturer of record: Pik Pak Industries (supplier consortium of forged stainless and tungsten precision-tool manufacturers).

UK Importer / Distributor: Toolsmith Ltd, Company No. 16520777, 39 Heather Road, Birmingham B10 9TE, United Kingdom.

Contact for adverse event or vigilance reporting

If you are an EU/EEA-resident healthcare professional, distributor, or patient and you wish to report an adverse event, malfunction, or product safety concern related to a Toolsmith / Pik Pak medical-device-adjacent instrument, you can contact us in two ways:

  • Toolsmith Ltd (UK): info@toolsmithltd.co.uk · +44 (0)78 4949 5050
  • IBC Sweden (EU Authorised Representative): we will forward the report to the rep and confirm receipt within 5 business days. Where the device is regulated as a medical device, vigilance reports are also notified to the relevant Competent Authority under MDR Article 87.

UK General Data Protection (UK GDPR Article 27)

For EU/EEA-resident data subjects exercising rights under UK GDPR Article 27, Pik Pak Industries via IBC Sweden also serves as our EU/EEA-side contact point for data-protection enquiries. UK ICO complaints may also be raised directly: ico.org.uk/make-a-complaint (Toolsmith Ltd ICO registration: ZC147961).

Renewal & ongoing compliance

The IBC 02502141A registration is reviewed annually. Next scheduled renewal: 5 January 2027 (target completion before 12 February 2027 lapse).

This page satisfies our public disclosure obligations under MDR Art. 11 and 13 and is referenced from the storefront footer and the contact information policy.