Advertising and promotion of reimbursement for medical devices

On Tuesday 22 February I delivered this presentation at the Q1 2nd Annual European Medical Devices Reimbursement Conference.

My presentation addressed the question of what constraints there are on companies providing information with respect to coverage and reimbursement to customers. There are many, both contained in mandatory law and self-regulatory rules.

It was remarkable to hear how similar and at the same time different national reimbursement systems are in the EU, as for medical devices no harmonisation has taken place yet in the field of reimbursement. For pharmaceuticals there is some in the form of the Transparency Directive. However, the upcoming Cross-Border Healthcare Directive is expected to lead to de facto harmonisation in the field of medical devices as it provides for a legal basis for HTA cooperation, as you will also see explained in brief in my presentation.

Navigate through our knowledgebase

Related articles


Regulatory pathways for clean meat in the EU and the US – differences & analogies

Now that the US regulatory framework is shaping up, the analogies and differences with the European regulatory framework for market access for clean meat becomes more and more clear. This blogpost reports these analogies and differences, based on the agreement that the FDA and USDA recently concluded on their cooperation in the field of clean […]


Cannabis derived food products – what’s the current state of play?

Recently, CBD food products were qualified as Novel Foods requiring a market authorization. The lively trade in these products therefore currently seems to be at risk. However, not all cannabis derived products…

Read more


What to expect for 2019 with MDR and IVDR implementation?

Remember the CAMD Roadmap (dating back to end 2017) that promised us a roll-out of MDR and IVDR items that were sometimes even marked ‘high priority’ and how that lifted our spirits (at the time)? Remember how this was supplemented with the Rolling Plan, which promised the roll-out of all roll-outs for 2019? I have […]