With 100 days to go until the EU Medical Devices Regulations (EU MDR) come into effect, is your business ready for the change? Richard Castle, Global Account Manager Medical Device, sets out some of the challenges ahead for medical device manufacturers.
Groundhog Day may have passed, but many medical device firms will be feeling déja-vu as we head closer to the delayed introduction of the EU MDR on 26th May 2021. So what are the key things to look out for as these new regulations finally arrive, and how can you make sure your business operations are fully compliant from day one?
Based on our experience of working with a number of medical device firms, here are five key pieces of advice on how best to prepare for the change.
- Appreciate the scale of impact – it’s widely accepted that the new EU regulation will have major implications on labeling operations for every manufacturer. Many will need to rethink both their label designs and the systems as every single label being produced will need to be changed. Individual products need to be married with the right label at the right time, requiring a data-led label management to ensure critical data from across the globe is glued together whenever and wherever it’s required. So, this isn’t a regulatory tweak – it’s a genuinely radical shift in expectations, likely to have considerable impact across your business processes.
- Grasp the design challenge – we operate at a time when all medical products are facing heightened scrutiny due to their importance in the fight against COVID-19 . The new regulations play to this agenda by outlining several key elements that must be included on all labels – including warnings, additional serial numbers and lot numbers. For many smaller devices, this leaves little space to juggle essential elements. It is therefore a significant design challenge and will force organizations to create new label templates that make room for data not previously part of the label or underlying labeling system.
- Engage wider across the organization – many elements of the EU MDR, such as the introduction of UDIs, will touch upon multiple aspects of a business, so it’s vital to keep all relevant stakeholders in mind when developing your approach to compliance. Consider building integrated teams which include stakeholders from across and outside the organization to ensure you’re delivering the breadth as well as depth of solution required. A collaborative approach will be important.
- Data is key – reliable, connected data has never been more important since EU MDR compliance will increase the need for all areas of enterprise data to be integrated into packaging and labeling. Understanding and trusting your data model is essential: you need to know where your data is stored, how it’s maintained and what controls are in place to assure quality. Solutions that allow users to capture compliant data in a way that meets all needs will be the most effective and efficient way to crack the EU MDR challenge.
- Use the opportunity to innovate and future-proof your operations – the EU MDR also brings opportunities to do things differently. One example is that Instructions For Use (IFUs) can now be provided to the user electronically if the manufacturer clearly indicates this clearly on the packaging of each unit or device – which may offer newfound flexibility. Equally, while it may be possible to meet the EU MDR requirements through existing systems, if you do need new implementations, then think and plan carefully for the long term: go with a solution that gives you the agility to meet future regulatory challenges not just the present ones.
To find out more about EU MDR and how PRISYM ID can help your business, click here.
About the author
Richard Castle, Global Account Manager Medical Device, PRISYM ID
Having spent most of his career working within the print sector and enterprise level labeling software, Richard is always keen to learn about the regulatory labeling changes the industry faces, like EU MDR, and share his gained knowledge.
Richard is aware of the complex selection process for labeling solutions that customers experience, and he has a proven ability to align their requirements to solutions that are not only valid for today but aligned to any future impact of regulatory changes.