New EU Regulations Place the Spotlight on Medical Device Manufacturers
Four years of political negotiations are expected to reach a conclusion in the coming months as the European Council finalises its position on reforming legislation surrounding medical devices . For the hospitals and providers like the NHS and other medical institutions , the impact is likely to be significant due to the introduction of second-level checks . This extra layer of quality control will extend the time it takes for potentially life-saving devices to reach patients .
The new regulations will subject medical device manufacturers to increased scrutiny and and an increase in the cost of development and market vigilance .
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According to Martyn Gill , Managing Director for EMEA at InfinityQS International , it has never been more critical for medical device manufacturers to have an effective quality system to adhere to these new standards . In line with the Council ’ s proposals , software , physical instruments , apparatuses , appliances , and implants would all qualify as medical devices and fall subject to new safety and performance requirements . Gill suggests that these universal standards , more stringent than many of the current standards in place with individual EU countries , will force many manufacturers to adapt to higher standard of quality control .
“ The most important feature of the new legislation for manufacturers is the introduction of the new expert group ( the Medical Device Coordination Group ), which will have the power to review and comment on medical devices before they are put on the market . Every component of a device will be checked , requiring increased visibility across the entire enterprise and supply chain .”
Gill continued : “ Medical device manufacturers will have to register themselves , and the devices they place on the EU market , in a central database and fit their products with a unique device identifier to ensure traceability . This new , post-market surveillance system holds manufacturers responsible for ensuring the quality , performance , and safety of all of their devices . Beyond this approval process , the new regulations create complications for medical organisations ’ preferred supplier agreements . In the event that suppliers are unable to reach the level of quality / consistency that the new body demands , medical organisations will be forced to cancel these preferential arrangements and look elsewhere for their components .
“ Fortunately , the new regulations would go into effect three years after the entry into force , so manufacturers have time to prepare . The best approach is to implement a more effective quality management system , which can , among other things , track exactly where errors occur so they can be resolved quickly . In addition , the new standardised regulations will require quality across the supply chain to be monitored . By using a centralised quality control system , medical device manufacturers can attain full visibility across all production facilities and into supplier operations . This prevents situations in which errors in one plant cause an entire line of devices to be subject to review .”
Gill concluded : “ Though the adoption of the new standards will likely be arduous , medical device manufacturers can address and overcome the challenges that arise with the right technology and processes . End-to-end visibility of the product lifecycle will be the key to confidently complying with the new requirements .” •
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