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What are the New Medical Device Regulations?

by | Jan 1, 2018 | Healthcare, Technology |

What are the New Medical Device Regulations?

by | Jan 1, 2018 | Healthcare, Technology |

The EU have introduced new Medical Device Regulations which will become law in 2020. National regulators will have greater control and oversight of the medical devices industry.

In what is already a complex industry to develop new products for, what does this mean for device manufacturers?

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Devices with CE marks may have them revoked if regulators feel they should not have had the mark in the first place for medical use. Software providers will suffer too if they provide services which support clinical decision making, or monitoring software. This is because there is a risk (however small) that diagnostic and monitoring software may indirectly cause deterioration or death of a patient through the service it provides. This bumps that software into Class 2 or 3.

What are the Classes of Medical Device?

 

There are, roughly speaking, 3 different grades of medical device:

Class 1

These are devices that are non-invasive. They either do not touch skin, or only contact intact skin. Or they are only in contact with injured skin as a mechanical barrier.

Class 2

Invasive devices. Anything emitting radiation, surgical instruments etc.

Class 3

Anything that stays in the body, like implants or artificial hearts.

Why the New Laws?

 

There have been a few well reported lapses in class 2 and above devices, such as the PIP manufactured breast implants. Instead of using medical grade silicon in their implants, PIP used industrial silicone which wasn’t CE marked for medical device use. Gearing up for the changes, Class 2 medical devices now have to have clinical studies to prove their safety and efficacy. It’s cases like these and the huge surge in medical technology innovation that have fuelled the new litigation.

The new rules are likely to mainly affect manufacturers of Class 1 devices. Medical companies will have to adhere to a new ISO quality standard for medical devices. These companies will need to invest in managing device quality and working with a notified body which will likely cost thousands of pounds per device, with ongoing fees.

So, what are the overall effects of these changes on the Health Tech and Smart Health industries?

Big ripples. Some companies may have to spend significant sums to keep their products on the market, and others will lose their CE marks. Once the dust settles though, by 2020 we might see a more accountable and progressive group of technologies.

What are the Overall Effects of these Changes on the Health Tech and Smart Health Industries?

 

Big ripples!

Some companies may have to spend significant sums to keep their products on the market, and others will lose their CE marks. Once the dust settles though, by 2020 we might see a more accountable and progressive group of technologies.

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