The EU's Medical Device Regulation (MDR) is a directive that sets the quality standard and safety guidelines for medical devices being produced in or supplied to any country in the EU.
Similar to the FDA's unique device identification (UDI) system, EU MDR will establish a robust, transparent, predictable, and sustainable regulatory framework for medical devices to ensure high-quality and safe product packaging.
The MDR goes into effect in May 2020 and is four-times longer than the previous regulation – greatly affecting what information goes onto product labels and packaging. Until now, different European countries have interpreted and implemented the directive in different ways. But implementing the MDR directive across the EU equates to:
- transparency through an end-to-end verification system wherein unique, serialised codes are printed on every medical device and each code links back to the EU's main database
- traceability throughout the supply chain, from manufacturing, to store shelf, to end user
- consumer trust with thorough instructions for use (IFU) and universally recognised symbols on packaging.
However, the regulation presents a content and design dilemma for life sciences companies; they must meet these new regulations if they want to stay in the EU marketplace and produce error-free product packaging consistently to avoid costly fines and recalls.
What to know about MDR
MDR requires life sciences companies to display a new set of information and symbols on product labels. Specifically, labels will need to show UDI numbers – used to track devices – and IFUs.
"The MDR goes into effect in May 2020 and is fourtimes longer than the previous regulation – greatly affecting what information goes onto product labels and packaging."
IFUs will also be required on product information channels, like a company's website. IFUs must allow patients to see what the use of the device is, guidelines for reuse, warnings related to device disposal and incident reports in relation to the device.
The EU's MDR policy states that medical device labelling must be in the national language and 'clearly comprehensible to the intended user or patient'. Since people speak more than 30 languages in the EU, a number of symbols have been developed to make labels as universally comprehensible as possible:
- A crossed-out box for 'do not use if the package is damaged'.
- An umbrella with raindrops for 'keep this package dry'.
- A box containing the letters 'UDI' to be placed adjacent to the UDI number.
Under the new regulations, importers must print their name on the IFU, device or packaging, and companies that translate, relabel or repackage devices will also need to place their name on the product.
The MDR won't just affect new products. Existing medical devices will need to be recertified, and the definition of 'medical device' has changed to include products such as contact lenses and cleaning products for certain devices. This means that a lot of SKUs are about to get a packaging makeover.
What life sciences companies can do to prepare
With more than 30 languages and myriad rules to track and follow, it'll be no easy task for life sciences companies to adhere to the new MDR. However, one way to reduce the mayhem is to adopt a label and artwork management software to track all of the necessary packaging changes – and the workflows involved in each – from design brief to production.
