last update 2021-06-25

Medical devices

are in many countries of Europe and the United States regulated through laws and rules which are not always clear and therefore there is room for interpretation.

The reason is not always product specific - for example a specific technique - but often based on economical reasons which are not only influenced by politicians but also by health insurances.   

Product specific requirements are in most cases harmonized on the basis of DIN norms.  But between the countries there are often big differences in the areas of the proof of detectable effects, specific indications, declarations, claims, etc.  Country specific product compliance needs local expertise which is acquired and maintained locally.

Different

Reimbursement is almost always the most important common denominator in the identification of those countries which are chosen for the registration of medical devices.  As soon as the countries are identified, the process of registration plus the process to reach reimbursement brings special challenges for the registrar.


Not only for the United States, also for big parts of Europe it’s true, complete or partial reimbursement is just a part of the health market.  Only the very detailed knowledge of country specific markets give the ability to make all of the given chances transparent.


Our consulting within the area of medical devices goes far behind the registration of products.  We provide specifically for each country and product all the necessary information about existing markets, relevant laws and rules and often as one of the most important things, all the facts about reimbursement in private and government regulated health markets.

 

In Belgium, France, Ireland, Italy, The Netherlands, Portugal, Switzerland, Cyprus, Denmark, Finland and Baltic States, Greece, Hungary, Iceland, Spain, Sweden, Turkey and United Kingdom we recomment to work with our Agora Partners. www.agora-consulting.org


We have often proven in Germany and the United States, we can open doors which cannot be opened without local presence, specific knowledge and the necessary connections.
You profit from the difference.