The new EU Medical Device Regulation (MDR) and the EU In vitro Diagnostics Regulation has come into force, and medical device manufacturers (and the businesses involved in their supply chains) now only have 18 months to comply in full to the former – the EU MDR (26th May 2020).
So, the clock is well and truly ticking, but what makes matters worse is that despite awareness to the new regulations being relatively high, a survey published in October by KPMG and the Regulatory Affairs Professionals Society (RAPS) found that four-fifths of regulatory and quality leaders at medical device companies lack understanding of the EU MDR.
Why do we have new regulations?
You need to look no further than the ‘PIP’ breast implants and DePuy metal hip replacement scandals for evidence of why new regulations needed to be introduced, as both these events highlighted weaknesses in today’s legislation. The new regulations aim to improve the quality, safety, and reliability of medical devices, while also strengthening the transparency of information for consumers and enhancing the vigilance and market surveillance.
Don’t assume that your business won’t be impacted
The new regulations will be far reaching. For instance, software is included as a ‘medical device’, and products previously considered accessories to those devices such as cleaning and disinfecting products. The regulations also encompass products without an intended medical purpose such as contact lenses, dermal or other fillers, and equipment for liposuction to name but a few.
At CCL we’re advising our medical device clients that a good starting point is to review their product portfolios to understand which products need to comply. Also, importantly, all the actors in the supply chain will now have potential responsibility for defects in devices – previously the regulations focused solely on manufacturers.
At the same time, don’t assume that Brexit will mean that you won’t need to comply to this new EU law as legal experts are advising that regulatory alignment between the UK and the EU in respect of this medical regulatory matter is likely to continue.
Of particular interest to our business and our customers that operate within the medical sector, is one of the core aims of the new regulations – to improve transparency of information for consumers.
The introduction of UDIs
The changes will also mean that each device will now need to have a unique device identifier (UDI) that must be placed on the label and/or package of medical devices. The UDI produced for a device comprises of a UDI-DI (device identifier – specific to a manufacturer and device) and a UDI-PI (production identifier – identifies unit of device production).
This UDI will then be logged on the European database for medical devices (EUDAMED), and the records will be updated to give a living picture of devices as they move through the supply chain, which will help detect and reduce counterfeiting.
The UDI information assigned to medical devices will also need to be tracked by manufacturers, authorised representatives, importers, and distributors. Therefore, it is very likely that all these parties will need modify their quality management system to ensure information is not lost but stored in a proper, systematic way.
The path to compliant labelling and traceability
From our experience of developing traceability products and systems for over 35 years for both small businesses and large global corporations, at CCL we have found that, in general, companies require either printed products direct for their application, or digital printing systems so they can print on demand. Providing the best solution that fits the requirements can be split into two elements.
- Determining the right base material to provide the carrier of information requires durable flexible substrates that retain the information under stringent environmental testing. It is also necessary to combine the substrate with specialised adhesives to ensure the information is adhered to the product for its lifetime which may include washing cycles, high temperatures, and humidity. This must take into account the composition of the material it is being applied to, the surface texture, and surface energy.
- The second consideration is how the information is printed. This needs to be compatible with the label substrate to ensure it provides a high quality print that is durable and readable both electronically and by eye. By developing specialised topcoats, CCL have been able to provide a wide range of materials and printing systems that meet the harshest environments a product can be subjected to.
Implementing a traceability system including data capture can be straight forward with proven off the shelf labels, hardware, and software. But, ensuring that the system lasts the test of time and is individually customised to the particular product and environment is critical, and our advice would be to speak to a specialist manufacturer, such as CCL, as we understand both the technical aspects and we can deliver both off the shelf and bespoke solutions.
The writer is Tim Congdon, European Business Development Manager at CCL Design UK. For further information on CCL Design’s brand protection and security technology, email CCLDesignelectronics@cclind.com
