CE Certification

Post Brexit MHRA Requirements

As a result of Brexit the UK Medicines and Healthcare products Regulatory Agency (MHRA) now manages the medical device regulatory environment for the UK and has made 2 key changes:

1. UK Responsible Person (UKRP): Anser Medical Ltd acts as the UK responsible person for the medical device manufacturers whose products we supply. These products have all been registered with the MHRA and can legally be sold within the UK.
2. UK Conformity Assessment (UKCA) Mark: Whilst devices with CE Certification under MDD can be registered and sold in the UK up we are working with our suppliers to be ready to issue product with the UKCA mark as and when required.
   

As a requirement to supply medical devices through public contracts participating organisations need to have in place a certified ISO9001:2015 or equivalent Quality Management System (QMS).

Anser Medical's ISO9001:2015 QMS is audited annually by bsi and certified compliant (certificate reference number FS 656377).

Our Quality Policy in Brief: It is the objective of our quality policy to deliver onsite within 4 days from receipt of a customer order, fit for purpose medical devices with a shelf life of not less than 24 months.

To view the full company quality management policy click here

Controlled Stock Storage

As a requirement of the EU MDR, which we were working towards before Brexit, and as part of our ISO9001:2015 quality management plan-do-check-act processes all stock storage environments are continually monitored to ensure compliance with manufacturers specification and the monthly data is documented.

The temperature/humidity sensors are annually calibrated and certified against a National Standard.

Automatic Identification and Data Capture

As a requirement for the EU MDR and NHS's Scan4Safety we have been working with our suppliers to ensure they provide stock with the correct GTIN 14 bar codes on all packaging levels as well as enhanced 2D bar code labels containing the GTIN 14, Lot or Batch Numbers and Expiry Date.

We are also working with our suppliers to ensure they register their products with a Global Data Synchronization Network (GDSN) provider as soon as possible.

DATA Security

To ensure our IT infrastucture is resilient to any cyber attack and that our data remains secure we annually review are hardware and software against a rigourous criteria as defined by the National Cyber Security Centre and assessed by Assure Technical.

Anser Medical complies with the requirements of the cyber essentials scheme and holds a certificate of assurance with ref No: IASME-CE-013474

We regularly review our compliance wthin the General Data Protection Regulations (GDPR) and have registered the organisation with the Information Commissioner's Office. Certificate No: ZA476228

NHS Access Credentials

Anser Medical representatives have membership of both credentialling organisations to facilitate access to customers.

For MIA we are Tier 3 Approved and for Intellicentrics we hold Premium Membership.

Both memberships are renewed annually.

Environmental & Sustainability

Anser Medical understands its corporate social responsibility is to achieve net zero carbon footprint as soon a possible and partner with the NHS in helping it reach net zero as per the NHS Net Zero Report.

Our current environmental policy is driven by and through the  ISO9001:2015 Quality Management System. This includes monitoring the firm’s annual carbon footprint and with the help of an external provider (Carbon Footprint Ltd) complete a self-certifying calculation to arrive at an annual value which is then offset through a verified carbon reduction project.

We have now started implementing ISO14001 and will run this in parallel with ISO9001 and anticipate obtaining certification by mid to late 2022.

To access our latest Carbon Reduction Plan click here

To access our latest Sustainability Report click here

Anser Medical's Modern Slavery Policy Statement

Modern slavery is a crime and a violation of fundamental human rights. It takes various forms, such as slavery, servitude, forced and compulsory labour and human trafficking, all of which have in common the deprivation of a person's liberty by another in order to exploit them for personal or commercial gain. We have a zero - tolerance approach to modern slavery and we are committed to acting ethically and with integrity in all our business dealings and relationships to ensure modern slavery is not taking place anywhere in our own business or our supply chain; furthermore, we expect all organisations we do business with both internationally and within the UK to adherence to local and national laws and allow their employees:

-      the freedom to terminate their employment.

-      the freedom of movement to seek employment elsewhere.

-      the freedom of association.

-      to be free from any threat of violence, harassment

        and intimidation.

-      to be free to choose to do overtime and it not be

         compulsory.

-      to be free from any form of discrimination.

-      not to be liable to worker-paid recruitment fees.

-      not to be subject to confiscation of their original 

        identification documents. 

Anser Medical will not knowingly use unlawful child labour or forced labour in any of the products and/or services it provides, nor will it accept commodities, products and/or services from suppliers that employ or utilize child labour or forced labour.

We are also committed to ensuring there is transparency in our own business and in our approach to tackling modern slavery throughout our supply chain. We expect the same high standards from all our contractors, suppliers, and other business partners. This policy applies to all persons working for us or on our behalf in any capacity, including employees at all levels.

Anser Medical’s recognises that our supply chain contributes the greatest risk for Slavery and Human Trafficking since we source medical devices from both Europe and Asia. To mitigate this risk, we undertake due diligence when taking on all new suppliers and require them to adhere to this policy, and annually review our existing supply chain using the following key performance indicators (KPIs):

1.   Ensure we pay our suppliers promptly at or around 30 days.

2.   Ensure all existing and new suppliers confirm in writing their

      adherence to this policy.

This policy does not form part of any employee’s contract of employment and is updated each financial year. 

For the full details of our policy click here.