FEATURE TEST & MEASUREMENT IDENTIFYING WAYS TO ENSURE COMPLIANCE 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. A recent report stated that only nine
Matt Surgeon, UK sales director at CCL Design, asks if you are prepared for the May 2020 EU MDR deadline, and offers advice on complying with the unique device identifier (UDI) requirement
M
edical device manufacturers (and the businesses involved in their supply
chains) now only have two months (26th May 2020) to comply in full to the EU Medical Device Regulation (MDR). So, the clock is well and truly ticking, but
what makes matters worse is that despite awareness of the new regulations being relatively high, there has been a lot of uncertainty and medical device companies have reported that they have a 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. 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 Design, we’re advising our
medical device clients that a good starting point is to review their product portfolios to understand which products need to
16 MARCH 2020 | PROCESS & CONTROL
comply. Also, 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 with 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 in the medical sector, is one of the core aims of the new regulations – to improve transparency of information for consumers. 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).
The MDR changes will 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
Notified Bodies have received accreditation under the MDR to assess the conformity of medical devices, but the EC has indicated that further accreditation announcements are under way. Despite this, it is CCL Design’s view that gaining full compliance for the deadline is still critically important. From our experience of developing traceability products and systems 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: 1. Determining the right base material to
The UDI information assigned to medical devices will also need to be tracked by manufacturers, authorised representatives, importers, and
distributors, so systems may need to be modified to ensure information is not lost
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. 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 crucial, and our advice would be to speak to a specialist manufacturer, such as CCL Design, as we can deliver both off-the- shelf and bespoke solutions.
CCL Design
www.ccldesignelectronics.com
/ PROCESS&CONTROL
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