European Handbook of Medical Devices Regulatory Affairs 2019 –

Handbook of Medical Devices Regulatory Affairs 2019”
has been added to’s offering.

As medical device quality assurance and regulatory affairs
professionals, it can be challenging to stay on top of changes happening
in our industry. Few people have the time to read lengthy articles these
days and although many online newsletters exist, they are often packed
with PR releases, ads or unrelated information. That is why we started
this Handbook for QA/RA professionals in the medical device and IVD

Medical device regulation around the world has gained more importance
than ever. Governments and regulatory bodies across the region have put
in place new regulatory systems or refined the existing ones. A
registered product requires a lot of technical documentation to prove
its efficacy, safety, and quality. A smooth and successful registration
process demands soft skills for dealing with various key stakeholders in
the government, testing centres, and hospitals and among doctors.

This Handbook is an excellent reference for understanding what is
required to bring medical devices to market under the many different
regulatory systems in this important region. It begins by providing a
solid background to concepts such as device classification, clinical
trials, and labelling. Detailed information is then provided for each
country. It is a useful tool as companies and innovators are
increasingly looking worldwide to market existing products but also
provide a launching pad for new technologies.

This comprehensive Handbook is essential for researchers in medical
devices who want to get early exposure to safety and efficacy issues,
and for marketing/sales personnel who need to know the various
institutions that approve regulatory matters for market accessibility.
The contacts listed in the chapters are valuable and will lead readers
to have their first approach in understanding the dynamic process
involved in regulatory affairs.


  • Covers medical device regulatory system in different countries, ISO
    standards for medical devices, clinical trial and regulatory
    requirements, and documentation for application
  • Provides substantial background materials relevant to the particular
    area to have a better understanding of regulatory affairs
  • Presents contributions from authors working in regulatory organizations

The European Handbook of Medical Device Regulatory Affairs is a trusted
and increasingly valuable resource. The medical device industry will
find this book immensely useful to understand the regulatory
environment. Additionally it can used to better understand and access
the European market. Industry professionals will find it very useful for
their research and development projects, and it will ensure that the
product developed by them adheres to the regulatory environment.

For more information about this directory visit

Laura Wood, Senior Press Manager
E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call
For GMT Office Hours Call +353-1-416-8900
Topics: Medical