MedTech Week Magazine 2019 At a glance

Highlights from the 5th Edition of the Award-Winning MedTech Week Magazine

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I am particularly pleased to see so many examples of companies reaching out to their communities and engaging with employees – after all, medtech is really about people rather than technology.

Serge Bernasconi
Chief Executive, MedTech Europe
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Perspectives New role for Clinical Research Organisations
Regulations and legal, Expert

New role for Clinical Research Organisations

Two new EU Regulations will require the collection and analysis of more data during clinical investigations

Perspectives Green is the new black
Value of medtech, Expert

Green is the new black

Climate action is rightfully gaining space on the policy agenda. Healthcare is part of the problem and must become part of the solution.

Perspectives Improving the lives of people living with diabetes
Diabetes, Expert

Improving the lives of people living with diabetes

It is incredible when I think that nearly 100 years have passed since the discovery of insulin. Since then, insulin has saved the lives of millions of people living with diabetes around the world.

Perspectives What do patients want
Diagnostics, Expert

What do patients want?

Patients don’t care about technology – they care about the quality of life

Perspectives Career inspiration My journey in biomedical engineering
Career and education, Expert

Career inspiration: My journey to biomedical engineering

At the age of seventeen, I was good at maths and sciences, but I did not know what to study after secondary school.

Perspectives Are you ready for Eudamed
Regulations and legal, Expert

Are you ready for Eudamed?

One of the biggest changes on the healthcare horizon will be new EU requirements for product information. If you are not already preparing for this, start now – the clock is ticking.

Perspectives Changing health changing lives
Value of medtech, Expert

Changing health, changing lives

Our sector has changed a great deal in the last decade, but there is much more innovation to come – notably in customisation and data.

Perspectives Incontinence  Breaking the taboo
Value of medtech, Expert

Incontinence: Breaking the taboo

The condition can be treated, often cured, and always managed

Perspectives Will it make the boat go faster
Value of medtech, Expert

‘Will it make the boat go faster?’

We need to work in partnership with healthcare providers to understand the true value of technologies.

Perspectives The future of medicine is personal
Value of medtech, Expert

The future of medicine is personal

We must all play our part in embedding personalised medicine into Europe’s healthcare systems

Are you ready for Eudamed?

One of the biggest changes on the healthcare horizon will be new EU requirements for product information. If you are not already preparing for this, start now – the clock is ticking.

Lionel Tussau

Director of Business Development, atrify GmbH

Today’s patients, clinicians and savvy consumers demand access to trusted product information to make informed decisions about healthcare. This means companies must spend more time collecting and validating data about their products which is then provided to regulators and/or uploaded to databases. 

The new European Medical Device Regulation (EU 2017/745) established Eudamed, the European UDI database which will soon be full of information about medical technologies. When it is up and running, manufacturers will be required to enter new or modified data about their products in Eudamed on an ongoing basis.

From speaking to manufacturers, large and small, I know some will be ready for this transition – but others need help. The new requirements, coupled with existing regulatory and compliance responsibilities, can seem overwhelming.

For medical device manufacturers, there are several agencies globally that require updated information on the safety and performance of products. I see opportunities for manufacturers to find efficient ways of complying without reinventing the wheel.

The key to meeting obligations is to leverage data prepared for existing databases to comply with the new responsibilities that Eudamed brings. This will give companies more time to focus on producing the high-quality products that their customers and patients love.

2020 is fast approaching. The best advice I can offer is to start thinking – and acting – now to ensure you are ready for Eudamed.

What is Eudamed?

Eudamed is the European Databank on Medical Devices. It’s a secure, web-based portal that acts as a central hive for the exchange of information between national competent authorities and the European Commission. Eudamed was created with the purpose of strengthening market surveillance and transparency with regards to medical devices placed on the European market, by ensuring the effective collection and visualisation of all relevant information.

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