With the EU MDR looming, medical device organisations have an opportunity to improve organisation-wide best practice, rather than seeing achieving compliance as a short-term business overhead. Enforced compliance such as this gives medical device organisations the chance to organise and cleanse their labelling data and in turn create downstream value now rather than later.

Many organisations lack corporate oversight of their labelling estate and there are many reasons why this is the case. Whilst there is no quick fix to the discovery, audit and update of labelling artworks dispersed across multiple sites, we see EU MDR as an opportunity to put things right. Implementing a cloud-based solution to ‘connect the disconnected’ is the approach we would recommend to take control of your labelling data now ahead of the next wave of regulatory changes.

Failing to comply with EU MDR regulations can have huge consequences on your medical device organisation, which may result in costly product recalls, and delays in the distribution of products in Europe.

Bob Tilling, New Business Development Manager at Kallik says, “The most important thing to ensure compliance is to ensure you have a thorough understanding of the requirements. The biggest challenge is the scale of the task – you must investigate how many pieces of artwork you have to change and then create a plan to move through them. Once you’ve identified these, you need a project to make these changes, approve them, and pass them out to subject experts for verification that the changes are correct.”

Employing a joined-up, cloud-based labelling and artwork management solution therefore, can ensure you are using the changing regulations to your advantage. As we mentioned in our previous blog, the time to act is now.

This approach has a number of benefits:

  • It connects historically disconnected people and processes: a cloud-based solution makes storing, versioning, and modifying existing label layouts to accommodate new symbology and statements required for EU MDR a much simpler task.
  • Increases traceability: each label is visible to all stakeholders and simplifies collaboration, change, and compliance.
  • Reduces the impact of future regulatory and organisational-driven labelling changes: each impacted label can now be quickly identified, updated and re-printed along with a complete audit trail of changes making it easy to demonstrate due diligence to regulatory bodies when requested.

Adopting a cloud-based approach better equips medical device organisations to respond quickly and efficiently to future changes in legislation, new market opportunities, and simply the daily labelling challenges in bringing new products to market.

“It’s all about connecting the disconnected. You’ll have master labelling and artwork assets in a variety of artwork management systems – all of which are disconnected. By having a joined-up, cloud-based artwork management system all of these things get joined up, from their very creation, to the changes required for MDR, right up to the label being attached to the product in the factory,” Bob explains.

At Kallik, we have responded to this challenge with our, cloud-based solution – AMS360. Once brought under control, AMS360’s ‘where-used’ capability makes it quick and easy to identify and update individual labelling assets and to produce time-stamped audit reports at the touch of a button. The cloud-based nature of the solution means it is quick to adopt across the broader organisation and by manufacturing partners. This means that in times of uncertainty, revisions and updates can be made in confidence as and when is needed.

Plan and prepare for the impact and uncertainty of the EU MDR with Kallik’s AMS360 solution. Get in touch with the team to find out how your organisation can benefit here.