Pharmaceutical companies selling medical devices and pharmaceutical products in the European Union (EU) will soon need to meet a new – and complex – set of regulations.
The regulations, called Medical Device Reporting (MDR), are four-times longer than the previous European medical device regulations. They will greatly affect what information goes onto product labels and packaging.
MDR, which will go into effect in May 2020, presents both a data and design dilemma for pharmaceutical brands, as the labeling of medical devices will come under greater scrutiny in the name of patient safety. Brands selling products in the EU must meet these new regulations if they want to stay in the market.
What You Need to Know About MDR
MDR requires pharma companies to display a new set of information and symbols on product labels. Specifically, labels will need to show unique device identification (UDI) numbers—used to track devices—and instructions for use (IFU).
IFU 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.
MDR states that medical device labeling 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, re-label, or re-package devices will also need to place their name on the product.
Ready for more? 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. Translation: a lot of SKUs are about to get a packaging makeover.
And the fun doesn’t stop there. Despite a publish date of May 2017, MDR regulations are still causing confusion across country lines. For example, according to Regulatory Focus, if there’s no Brexit deal, the U.K. will likely have its own set of rules for medical devices. This means pharmaceutical companies selling products across the EU and the U.K. will have to produce different packaging for each.
What Pharma Brands Can Do to Prepare
With more than 30 languages and myriad regulations to track, it’ll be no easy task for pharma companies to adhere to the new MDR regulations. However, one way to reduce the mayhem is to adopt a packaging management system to track all of the necessary packaging changes – and the workflows involved in each – from design brief to production.
A good label and artwork management system will allow pharmaceutical companies to simplify the packaging content management process for label changes by giving brands a central repository for storing all essential data related to each medical device, with set permissions for who can view, download, and edit files. You can also track version changes, and so can outside parties such as clients, agencies, and printers.
Brands that use a label and artwork management system can also create new templates and automatically populate the templates with approved data from the repository, so packaging designers have a realistic view of the volume and types of data elements they’re organizing on the new package.
In addition, workflow management features allow all stakeholders (design, translation, regulatory agencies, printer converters, and more) to simultaneously view and collaborate on projects in progress, which improves quality control and simplifies the packaging approval process – making sure each new package is “shelf-ready” by May 2020.
Pharma companies will need to make some tough changes to meet MDR regulations, but it’s not an impossible undertaking. Esko WebCenter allows pharma companies to successfully navigate the complexities of the MDR regulations and ensure that each language is properly translated, each symbol is in its right place, and each package complies with all of the new regulations before the deadline.