Novo Nordisk A/S

We thank the Commission for the possibility to provide feedback on the targeted revision of the MDR/IVDR. We fully support the initiative to streamline and simplify the regulatory framework while preserving a high level of public health and patient safety. Please find our comments in the attached file.

Novo Nordisk appreciates the opportunity to provide feedback to the call for evidence on the targeted revision of the EU rules for medical devices and in vitro diagnostics. We support the initiative to streamline and future-proof the regulatory framework while preserving a high level of public health and patient safety.

The review of the General Pharmaceutical Legislation is an important opportunity to improve the effectiveness and efficiency of the regulatory system in Europe. Maximising patient benefit should always be the guiding principle–and the competitiveness of the system contributes to this. Enhancing competitiveness includes the flexibility to embrace new scientific and manufacturing developments, and new sources of data.

Europes competitiveness has taken a serious hit in the recent years, particularly in biotechnology. The EU Biotech Act I is a positive step towards strengthening the European biotechnology ecosystem with measures to accelerate clinical trials, reduce regulatory complexity and incentiv-ise innovation in Europe all improving patient access to best-in-class medicines.

Novo Nordisk A/S welcomes the European Commission's (EC) initiative to develop a Biotechnology and Biomanufacturing Act, aiming to transform Europe from being a regulatory leader to a global champion of biotechnology innovation.

Novo Nordisk supports strengthening early detection and action on cardiovascular disease (CVD) across the EU through systematic cardiometabolic health checks that explicitly include the major chronic conditions driving risk - i.e. obesity and type 2 diabetes (T2D).