Micronclean transitioned to the EU Medical Device Regulation and certified under the UK Medical Devices Regulation

7-Jun-2022

Micronclean are pleased to announce a successful transition to the EU Medical Device Regulation. Additionally, they have also obtained certification under the UK Medical Devices Regulation and can now also place the UKCA mark on devices

Micronclean’s Medical Device Technical Specialist Philip Borrington commented: “We are delighted to obtain the two new certifications. The EU Regulation in particular is much more extensive and stringent than the old Medical Device Directive and this award marks the conclusion of a two-year project to upgrade our processes to meet the new requirements”. The UKCA mark has been obtained over a year before it is legally required in the UK

Micronclean established its MicronDevices business in 2007 (then known as ‘Sterile Packs’) and throughout that time has developed expertise and knowledge supplying the drug compounding market.

Within our dedicated Class 6 cleanroom we have the capability to rapidly develop custom packs to meet customer specific requirements and our in-house software BRC (Batch Record and Control) provides full traceability.

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To ensure continuity of supply to our customers at all times Micronclean does not operate a just in time policy for either its components or finished goods in our warehouse. We have substantial stocks of both to enable immediate order fulfilment.

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