PICKERING INVESTS £5M IN UK AND CZECH REPUBLIC


FACILITIES TO MEET GROWING DEMANDS


Now in its 50th year, The Pickering Group is undergoing a significant expansion in order to support excellent growth and new product development. In addition to redeveloping


its global headquarters and manufacturing centre in the UK, Pickering is investing in an additional 3000m2


NEW EU MEDICAL DEVICE REGULATIONS: BE AWARE OF THE CHANGES by Tim Congdon, european business development manager at CCL Design UK


On May 25th 2017, the new EU Medical Device Regulation and the EU In Vitro Diagnostics Regulation came into force. Now, medical device manufacturers (and businesses involved in these supply chains) have less than two years to comply in full to the former (26th May 2020) and four years to comply with the latter (26th May 2022). 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. It’s important that all business involved in the medical device/product supply chain are aware of these new


regulations as a wider set of products will now be included. For instance, software is included as a ‘medical device’, and products previously considered accessories to those devices (e.g. cleaning and disinfecting products). This means that 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’re a UK based manufacturer, don’t assume that post Brexit this EU law will not impact your


facility in the


Czech Republic. This Czech facility is already producing many of Pickering Interfaces’ vast array of switching and simulation products in the industry for PXI, LXI, and PCI applications, including value add assembly such as cable and connector solutions. In total, the investment in the UK and Czech is expected to reach £5M. CEO, Keith Moore, said: “Despite


predictions as far back as the 1970s that our relay business would have a limited lifetime, we have seen exactly the reverse. We are challenged by our customers – including our sister company Pickering Interfaces – to deliver ever-higher performance in miniature packages, and that means that demand for our reed relays has never been higher. “Similarly, demand for our


simulation, test and verification products is also increasing, thanks to the complexity of today’s automotive and semiconductor manufacturing systems and the need for automated test processes. Therefore, we needed to streamline our manufacturing operations and add more capacity.” www.pickeringrelay.com


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. The changes to enhance the traceability and transparency will mean that each device will now need to have a


unique device identifier (UDI), and the information 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. 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. From our experience of developing traceability products and systems for over 35 years for both small


businesses and large global corporations, we have found that, 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. 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. www.ccldesignelectronics.com


BEARING COMPETITION: MANUS AWARDS 2019 NOW OPEN FOR ENTRIES


igus has announced that the manus awards 2019 – the competition for plastic plain bearing applications – is now open for entries. The three winning applications at the last awards were an exoskeleton, an articulated robotic arm and a research project on space debris. To enter the latest competition, engineers need to apply online and present their designs to the jury with short texts, photos and videos. Whether


D


Innovative Enclosure Solutions for Industrial & Electronic Applications


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Standard | Modified | Special Tel: 01709 386630


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production applications for the industry or individual pieces, each entry is treated equally, the only condition is that at least one built prototype of the presented application exists. The deadline for entries is 22 February 2019 and the winners will be announced at the Hannover Fair 2019. The winners can look forward to prize money of up to 5,000 euros. www.igus.eu/info/manus-award


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