AXREM Host Barcoding Workshop for Members
14 February 2020
Following feedback at an AXREM Supply Chain Collaboration meeting and a subsequent member survey that took place, we established that members required more information about barcoding and the requirements of the new Medical Device Regulations which come into force in May.
Working with NHS Supply Chain and GS1 UK colleagues AXREM hosted a Barcoding Workshop on Wednesday 12th February when we welcomed members and representatives from supporting organisations. The day covered what NHS Supply Chain expectation of member companies are including information such as timelines, a compliance road map and information about how and what information NHS Supply Chain are capturing from companies to ensure they are complaint. It was refreshing to hear that NHS Supply Chain can offer industry help and assistance with the process.
GS1 UK were able to give an overview of their work and developments within the healthcare sector and covered MHRA recommendations to be compliant with the new Medical Device Regulations. There was interesting content around GTINs, application identifiers and data matrix.
Barcoding has come to the forefront for health technology companies following the new Medical Device Regulation (EU) 2017/745, Article 27 – Unique Device Identification – paragraph 9 which states:
- Health institutions shall store and keep preferably by electronic means the UDI of the devices which they have supplied or with which they have been supplied, if those devices belong to class III implantable devices.
- For devices other than class III implantable devices, Member States shall encourage, and may require, health institutions to store and keep, preferably by electronic means, the UDI of the devices with which they have been supplied.
- Member States shall encourage, and may require, healthcare professionals to store and keep preferably by electronic means, the UDI of the devices with which they have been supplied with.
This was an informative day and AXREM wishes to thank all those involved and those members who attended.
More information about GS1 UK can be found here: https://www.gs1uk.org/our-industries/healthcare More information about the new Medical Device Regulations can be found here: https://www.gov.uk/guidance/medical-devices-eu-regulations-for-mdr-and-ivdr