Special focus
New EU medical device regs T
New regulations are set to have a major impact on manufacturers, as Tim Congdon, European business development manager CCL Design, explains
he new EU Medical Device Regulation and the EU In vitro Diagnostics Regulation came into force on 25 May
2017, and whilst there was a five-year pre- implementation period, only a few manufacturers have started 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. Specifically, this will not just impact medical
device manufacturers, but those businesses involved in these supply chains. With just over 18 months to comply in full to the EU Medical Device Regulation (26 May 2020), it is now time to start planning for this significant change. Equally, if each manufacturer meets this deadline in a pragmatic and planned way, they can then move on to complying to the EU In vitro Diagnostics Regulation (26 May 2022).
Why ThE ChaNgE? We have all witnessed the scandals of ‘PIP’ breast implants and DePuy metal hip replacements, and these high-profile incidents have highlighted weaknesses in today’s legislation. The European Commission expects the 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.
Do NoT bE CompLaCENT It is important that all businesses involved in the medical device/product supply chain are aware of these new regulations as a wider set of products will now be included by the legislation. For instance, software is included as a ‘medical device’, and products previously considered accessories to those devices (e.g. cleaning and disinfecting products). Therefore, businesses previously unregulated
may need to meet these new requirements, and medical device businesses will need to review their product portfolios to understand which products
need to comply. Importantly all the actors in the supply chain will, for the first time, have potential responsibility for defects in devices – previously the regulations focused solely on manufacturers. Equally, if you are a UK based manufacturer, do not assume that post Brexit this EU law will not impact your business. 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. At the same time, for those UK based manufacturers that do not already export to the US as they are already UDI compliant, it is even more important for these operations to start the compliance process as soon as possible.
CuTTiNg ouT CouNTErfEiTs aND improviNg proDuCT rECaLLs
The changes to enhance the traceability and transparency will mean that each device will now need to have a unique device identifier (UDI). These new labelling requirements will mean that UDI information must be placed on the label and/or package of medical devices. This means that 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. 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. This is likely to assist both with the detection of counterfeit devices and in the event of product recalls being required. At the same time, the UDI information assigned
to medical devices will need to be tracked by manufacturers, authorised representatives, importers, and distributors.
Do NoT forgET ThE WarNiNgs One of the biggest changes as a result of these new regulations, is that 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 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.
Instrumentation Monthly September 2018
firsT sTEps To CompLiaNT LabELLiNg aND TraCEabiLiTy In general, 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. 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 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. Finally, do not think that the regulator will not come knocking. 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 will need to have at least one person responsible for regulatory compliance, either within the organisation or as an available consultant.
CCL Design
ccldesignelectronics.com 27
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