MEDICAL ELECTRONICS FEATURE
Compliance with new EU medical device regs is just around the corner
Last summer the new EU Medical Device Regulation and the EU In vitro Diagnostics Regulation came into force. As a result, medical device manufacturers and the businesses involved in there supply chains only have two years to comply in full to the former (26th May 2020) and four years to comply with latter (26th May 2022). Tim Congdon, European business development manager at CCL Design UKexplores
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, introduced by The European Commission 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. Most businesses aren’t aware how far reaching the new regulations will be. 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.
A good starting point is for medical
device businesses to review their product portfolios to understand which products need to comply. Also, importantly, all the factors 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 anyone that operate within the medical sector, is one of the core aims of the new regulations – to improve transparency of information for consumers.
In general, companies require either
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 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 to modify their quality management system to ensure information is not lost but stored in a proper, systematic way.
Figure 1:
Barcode label for medical drug delivery
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: 1. 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. 2. 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 has 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
Figure 1: Printed barcode
including data capture can be straight forward with proven off the shelf labels, hardware, and software. The regulatory notes also cite that there will be enhanced market and post-market surveillance, with regulatory authorities having more rights to conduct audits, including unannounced visits. At the same time manufacturers (or their authorised representatives) will need to have at least one person responsible for regulatory compliance, either within the organisation or as an available consultant.
CCL Design UK
www.ccldesignelectronics.com e:
CCLDesignelectronics@cclind.com
/ ELECTRONICS
ELECTRONICS | SEPTEMBER 2018
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