OBJECTIVES: The Medical Device and In vitro Diagnostics Regulation (MDR/IVDR), imposes significant challenges on HTA and reimbursement for medical devices/in vitro diagnostics in addition to requirements on the regulatory side. This includes new software used to take decisions for diagnostic or therapeutic purposes (so-called e-health/digital health products). The analysis shows how the assessment of authorities will differ when products are classified differently and what the impact on existing technologies will be.

METHODS: Impact analysis of sample products newly classified in high risk class according to MDR/IVDR on HTA requirements and reimbursement decisions in Germany, France and Switzerland.

RESULTS: In Germany, medical devices of high "risk class" will be assessed in an HTA which increases with the higher number of high-risk products. The current approach is slow as only 13 procedures (06/2018) have been evaluated, majorly negative. Existing medical devices can be invoked for an HTA anytime. In France, the "forfait innovation" is an accelerated procedure for promoting the reimbursement of innovations initially only temporary/conditional with evidence development and may be evaluated in a full HTA process later. 13 positive opinions (2007-2018) have been published. In Switzerland, according to the ‘principle of trust’ it is assumed by default that for MDs/IVDs no formalised HTA process is necessary. However, anyone with a legitimate interest (e.g. physicians, hospitals or health insurances) can request it from authorities. Positive decisions are finally published in the procedures ordinance (152 benefits currently).

CONCLUSIONS: There is a risk that products may disappear due to immense administrative burden and requirements. Manufacturers might not be ready to be compliant with MDR/IVDR and HTA requirements. Further innovation backlog - neither notified bodies are yet ready to certify MDs/IVDs nor national HTA bodies are ready to adopt. Access to new and innovative devices for patients will take longer.