As you know, placing a new medical device on the market is the end result of long and laborious team work.
A medical device team can vary depending on the product type but it will almost always, without exception, include an innovator, an IP lawyer, a regulatory affairs and quality specialist, an R&D expert, a formulator, an engineer and a preclinical, clinical, marketing and business development expert.
To provide the best solution for clients, BioReg collaborates with top-quality, experienced and trusted partners and associates who have been carefully chosen over the years.
In this blog, we are delighted to present to you our long-term service partner – EU Authorized Representative, mdi Europa GmbH.
If I had to summarize in just one sentence the work that mdi Europa undertakes led by Michael Sander, I would probably say: ‘You always get more than you expect in a professional, thoughtful, timely and friendly manner. Thank you, Michael!’
More about the company
mdi Europa GmbH was founded in March 2000 to provide medical device manufacturers world-wide with flexible and well-adjusted service packages to assist clients to comply with EU legislation. mdi Europa GmbH acts as a European Authorized Representative (as defined in the Medical Devices Regulation (EU) 2017/745 (MDR), the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), the Medical Devices Directive 93/42/EEC (MDD) and the In Vitro-Diagnostic Medical Devices Directive 98/79/EC (IVDD)) for a wide range of companies – from start-ups to established corporations throughout the world.
The role of an EU Authorized Representative
European medical devices legislation stipulates the necessity of a European Authorized Representative, also known as EU Auth. Rep., EC Rep or AR, for manufacturers who don’t have their own location in Europe. EU Authorized Representatives act on behalf of manufacturers to undertake, among other matters, communication with the competent authorities.
See also mdi Europa’s new article on Clinical evaluation and equivalence – using literature under the MDR using this link: https://mdi-europa.com/clinical-evaluation-and-equivalence-using-literature-under-the-mdr/
Article Summary: Using literature for clinical evaluation was a common approach for setting up clinical evaluations under the MDD. This article discusses the new MDCG 2020-5 guidance document which illustrates to what extent clinical data from equivalent devices may be used for clinical evaluations under the MDR.
Please feel free to contact us directly – email@example.com – if you wish to learn more about the role of an AR or you have any other MDR–related question.