Despite the impending implementation date in May 2020, many companies have not yet grasped the full impact the new EU Medical Device Regulations (MDR) will have on product labelling. Kallik’s channel marketing manager, Graham Francis offers some practical advice on the topic.
The EU’s new MDR, which will go live in May 2020, has significant implications for labelling in all its forms.
Traditionally, medical device manufacturers’ product and package labelling, Instructions-For-Use (IFU) leaflets and website content have been managed by separate teams - with a risk of discrepancies in their content, as well as inefficiencies and delays launching new products or entering new markets.
But now, prompted by MDR, device manufacturers have an opportunity to do things differently, including making more use of electronic labelling and IFUs.
The main requirements under EU MDR affecting labelling activity are summarised below:
- Product information published on the manufacturer’s website must be kept up-to-date, including labelling content
- Unique Device Identification (UDI) data needs to be uploaded to the Eudamed database for all devices by 26th May 2020, with the UDI required on materials that fall under the FDA’s definition of labelling
- IFUs can now be provided in a non-paper format for the first time, however, manufacturers must indicate by means of a new symbol on the label that the IFUs are published in electronic rather than in paper form
- Device labelling must be provided electronically via the manufacturer’s website as well as in traditional printed form
- Details of the organisation’s European authorised representatives’ symbol, name and address must be provided on the label
- A new symbol must be included on the label identifying the product as a medical device
- Additional symbols must be added relating to device reprocessing and safety
Scoping the challenge
The scale of the challenge and the number of labels affected by the new requirements are easy to underestimate.
Where there are currently multiple systems and teams involved, there will be no single place to go to get an accurate view of labelling content. Added to this, there will be product-specific variants, country-specific requirements and localised content to keep track of.
To forward-looking organisations, EU MDR presents a major opportunity to implement a digital labelling strategy, which should be another consideration as enterprise labelling management projects are drawn up. This is being prompted by the encouraged adoption of electronic IFUs under MDR, which is much easier to contemplate if content is derived from the same single source.
The upshot is that organisations need full transparency across all of their global label assets - from individual symbols and statements, to label layouts and templates, IFUs, booklets and other promotional materials – in whatever format these exist.
The process of locating and importing the latest approved versions of each of the files involved (into a new, end-to-end enterprise labelling management platform) should not be underestimated. In our experience, it can take two to three times longer than anticipated to discover and collate the materials.
In parallel, a new data governance framework will be needed, ensuring that ownership of all labelling content is clearly defined and brought under control. This will need to be a gradual transition taking several months, and will result in the accountability for all materials (including electronic versions) falling to the labelling team.
Benefits delivered
Once everything is managed and controlled within a single platform, it becomes much easier to correlate changes across labels, IFUs and booklets to ensure accuracy, alignment and consistency, and even export accurate XML content directly to the website.
A structured yet adaptable approach to managing enterprise labelling will improve healthcare provider relationships and deliver better patient outcomes. It allows for the transition from documents to data, making it much easier to deconstruct and reconstruct labels, IFUs and booklets built on shared and approved content.
All of which adds up to a more connected medical device organisation that is much better placed to handle ongoing market and regulation-driven labelling changes.