How to survive the new Medical Device Regulations - InnoBrain

by Maria Pelagia
8 months ago
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On the 26th of May 2020, new compliance laws and regulations will be introduced to Medical Device manufacturers to improve the safety of patients and to ensure a sustainable regulatory framework amongst medical device providers.

The New MDR will bring EU legislation into line with technical advances, changes in medical science, and progress in lawmaking. The regulations aim to ensure that medical devices are safer and perform well, improving their quality, safety and reliability.

What do you need to know as a Medical Device Professional?

The new MDR will place more emphasis on a life-cycle approach to safety, backed up by clinical data and by increased control and monitoring by national competent authorities and by the EU Commission. If you are a medical device manufacturer, The Factsheet for Manufacturers of Medical Devices provided by the European Commission advises that:

  1. All your products ought to be classified appropriately
  2. All product documentation and evidence of compliance ought to be available in a timely fashion and should conform with the MDR 
  3. Lastly, ensure that you have the necessary systems in place to handle clinical evaluation, quality management, post-market surveillance, and liability for defective devices.
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Increased Responsibility to Ensure Patient Safety

In addition, stricter measures will take place to ensure the quality of medical devices that will be introduced or already are in the market. Medical device manufacturers will need to have systems of risk management, quality management, ought to conduct clinical evaluations and compile technical documentation.

Medical Device manufacturers will be called to assume more responsibility once their devices are on the market, and must ensure that they can cover financially any damages caused by medical devices.

Furthermore, regulatory compliance persons should be appointed by manufacturers. Tighter controls will be introduced on high-risk devices, awaiting consultation from experts at the EU level before market introduction.

Some “bad” news…

Quality assurance, product development and data reporting ought to be changed to conform to the new MDR. This can bring as a result higher costs and more time to ensure that a medical device is developed efficiently before it is launched to the market.

 In addition, since the classification of Medical Devices will be modified, some devices might be classified as riskier for patients than they were before, meaning that the process of certification can become more expensive and time-consuming. This can as a consequence slow down the process of medical device production.

Because of reclassification, many medical devices that did not have to go through clinical trial testing before will have to go through that process from now on. For medical devices that already are in the market, there will be a new reevaluation of clinical data and if they do not comply with the new regulations, manufacturers will have to carry out additional testings.

That’s not just it, because as a result of the new MDR post-market surveillance, intense monitoring and reporting for safety will add extra pain to medical device manufacturers who will have to extend their resources to comply.

Some good news…

You can test the usability and performance of the medical device, early on during the development process by using an innovative usability testing platform that allows you to cut down on costs and provide accurate results.

Estimates suggest that up to 70% of a product’s cost is determined at the design stage, and thus it would seem important to concentrate attention on hammering out any likely problems in manufacturing at this stage (Tidd et al. 2005).  Many companies spend less than 5% of their product budget on design and push instead for manufacture as soon as possible. (Tidd et al. 2005). 

Whilst this may reduce the time to market, it can also have a major effect upon costs. A variety of studies have consistently shown that attention to product simplification and design for manufacture can make substantial savings at later on.

Innovate the Usability testing of Medical Devices to avoid extra costs and reduce the time of certification

Usability testing of medical devices with a Brain-Computer Interface platform will allow medical device manufacturers to derive fast, reliable and objective results in an efficient and cost-effective manner.

By using the latest innovative technology in usability testing, you can prevent usability failures early on during the development process, while including people with communication problems, the elderly and children to make sure that the device is easy to use. In addition, with a BCI platform, you can see what your users feel and think when using your device because data is analysed with the help of AI algorithms and Neuroscience.

InnoBrain has developed a Brain-Computer Interface platform that will help you to:

  • Get diverse and inclusive data
  • Unbiased and objective results
  • Reduce evaluation time while increasing accuracy
  • Suitable for complex products and scenarios
  • Reduce the evaluation time using a real-time analysing process and a quickly adaptable platform to customer needs during the certification process.

Our Process

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Contact us today to hear how we can help you!

Sources:

European Commission (2020).Internal Market, Industry, Entrepreneurship and SMEs, Sectors, Medical Devices, New Regulations, viewed 31st of March 2020, https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/spread-word_en

Tidd Joe, Bessant John, Pavitt Keith (2005). Managing Innovation: Integrating Technological, Market and Organizational Change, Wiley: 3rd edition

Laege Middle Styrelsen (2019). New medical devices regulations, viewed 31st of March 2020, https://laegemiddelstyrelsen.dk/en/devices/legislation-and-guidance/new-regulations/

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