Medical Electronics
Manufacturers need to act now to comply to EU medical device regs
The clock started ticking on the 25th May last year to comply to new EU Medical Device Regulation and the EU In vitro Diagnostics Regulation, and whilst there was a five-year pre-implementation period, this is already down to three and a half years, with only a handful of manufacturers starting to take action. This is despite many industry experts recognising that this new regulation will have major implications for the labelling operations of every manufacturer across the EU. Tim Congdon, European business development manager at CCL Design UK tells us what companies need to do to make sure they are compliant
T
hese regulations are being introduced because of a number of scandals that has hit the industry. For instance, most of us have all witnessed the ‘PIP’ breast implant and DePuy metal hip replacements scandals, and these high-profile incidents have highlighted weaknesses in today’s legislation. The European Commission therefore introduced these regulations 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 are far reaching and will not just impact medical device manufacturers, but those businesses involved in these supply chains. It is my view that now is the time to start planning for EU Medical Device Regulation, so your business complies by 20th May 2020.
Don’t be complacent Businesses shouldn’t assume that they won’t be impacted by the new legislation as a wider set of products will now be included. Software is just one such example of a product that will be included as a ‘medical device’, and products previously considered accessories to those
devices (e.g. cleaning and disinfecting products) will also feature. Businesses should therefore review their product portfolios to understand which products need to comply.
Importantly all those involved in the supply chain will, for the first time, have potential responsibility for defects in devices – previously the regulations focused solely on manufacturers. This will therefore need a greater level of collaboration between manufacturers and all actors in the supply chain.
Compliance after Brexit? Many legal experts are advising that regulatory alignment between the UK and the EU in respect of medical regulatory matters still appears the most likely outcome of the current Brexit process. This will mean that these new regulations will remain in force even after we leave the EU.
Unique Device Identifier (UDI) One of the key requirements of the new regulations, is that each device will now need to have a Unique Device Identifier (UDI) to enhance both traceability and transparency. The UDI information must be placed on the label and/or package of medical devices, and at the same time, it will need to 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. This will help detect counterfeit devices and product recalls, as the UDI will be logged on
EUDAMED, so it will also be tracked
20 October 2018 Components in Electronics
by manufacturers, authorised representatives, importers, and distributors. 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 requires a specialist manufacturer.
A warning
Because of all of these changes, manufacturers will not only need to re- design their label templates they will also need think about the impact this will have on the device as naturally more data, will mean a larger label. This will be more challenging on smaller medical devices as 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).
At the same time, all warnings related to the device must now be printed on the label – when it was previously included on the IFU. Although the regulators say that this information can be kept to a minimum (with more detail in the IFU), manufacturers will need to think about which warnings to include, and if the product is a global one, the impact that producing this information in different languages will have on the product label.
Compliant labelling and traceability We have been developing traceability products and systems for over 35 years for both small businesses and large global corporations, and in general, we have found that, companies require either printed products pre-printed 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. Choosing the correct materials – 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 information for the label – 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. Finally, be aware that the regulator may come knocking It has been announced 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. Although regulatory compliance comes at a cost, it is my view that this cost is far outweighed by the benefits to the global manufacturing industry, and the billions of consumers that value both quality, safety, and reliability above anything else.
www.ccldesignelectronics.com
www.cieonline.co.uk
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