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

New role for Clinical Research Organisations

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

Șerban Marius Roșu

University of Timişoara and Municipal Emergency Clinical Hospital of Timişoara

The MDR on medical devices and IVDR on in vitro diagnostic devices are scheduled to be fully implemented (after a transition period) from May 2020 and May 2022, respectively.

The legislation demands a mandatory conformity assessment for all devices manufactured in the EU, to prove that they meet the legal requirements, perform as claimed and are safe to use.

Clinical Research Organizations (CRO) are assigned a more important role in providing scientific evidence and regulatory assistance during the whole process of placing a medical device on the market.

The Regulations emphasise a more robust clinical evaluation process. They also require clinical evaluations to assess whether there are sufficient data to prove the compliance of the device with the requirements for safety and performance, when used according to manufacturer's instructions.

The MDR requires the generation of a Clinical Evaluation Report (CER) after the investigation of a medical device, which is part of the technical documentation for the CE-marking process. These CER-related services can be provided by CROs.

A greater volume of data will be generated by device manufacturers and their representatives, and better data interpretation will be necessary to support their safety and performance claims.

As the quantity and quality of data collection and analysis increases, the new Regulations mark the beginning of a new era for CROs.

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