You might have noticed that issues discussed in Brussels, seem at a good distance from daily practice in Orthopaedic and Traumatology. This perception is often shared by many medical specialists.
Still, many issues debated and discussed in Brussels have an impact on daily practise, however indirect one. For instance, the discussions over the Medical Device Regulation reflects the challenges in the implementation of this piece of complex legislation and resulted in reduction of availability of some orthopaedic devices. It also resulted in a shift in industry’s strategies to develop or maintain medical devices on the market.
Discussions in Brussels on health-related issues have therefore an indirect impact on daily practice or sometime a deferred impact (i.e. when a piece of legislations starts its implementation phase).
At present, there are a number of issues discussed in Brussels that already have or will have a direct or an indirect impact on medical practise such as the revision of the Medical Device Regulation, the new pharmaceutical package, the AI act or the multiannual financial framework.
EU Biotech Act
On 16 December 2025, the European Commission proposed the EU Biotech Act to strengthen Europe’s biotechnology and biomanufacturing sectors. It proposes to amend specific parts of EU health and food regulations, to adapt the whole ecosystem to the needs of modern society and this fast-growing sector. The proposal include revising EU rules on clinical trials, advanced therapy medicinal products, substances of human origin, veterinary medicinal products, general food law, human organs and genetically modified organisms.
The Biotech Act intends to:
v Accelerate and enable EU-clinical trials authorisations.
v Encourage innovation with increased support, one regulatory pathway and regulatory sandboxes.
v Support funding, investment and access to capital, in a pilot together with the EIB Group.
v Boost bio-manufacturing capacity.
v Foster the use of artificial intelligence (AI) in health biotechnology.
v Enhance EFSA’s capacity to provide scientific advice to companies.
v Incentivise human and veterinary biotech medicine with high added value.
v Reinforce security by preventing the misuse of biotech and strengthen biodefence.
The EU Pharmaceutical Package
Last December, the Council and Parliament reached an agreement on the pharma package. Both institutions still need to formally endorse the deal, before it will be formally adopted.
The key features of this package are:
- 8 years data-exclusivity.
- Additional year of market protection for:
– Products addressing unmet medical needs,
– Products using comparative clinical trials in several countries,
– Products with new active substances. - AMR Voucher system is maintained, with a 12 month transferable exclusivity voucher.
- Broadening of the Bolar exemption (for generic manufacturers).
Medical Device Regulation
The European Commission issued a Proposal for a regulation to simplify rules on medical and in vitro diagnostic devices which will amend the Medical Devices Regulation, the In Vitro Diagnostics Regulation and its Annexes. Last December, the Commission published a proposal to revise the Medical Devices (MD) and In Vitro
Diagnostics (IVD) Regulations, aiming to simplify requirements and reduce costs while maintaining patient safety.
The Commission expects to have:
- Reduced administrative burden.
- More proportionate and targeted requirements.
- Support for innovation.
- Enhancing the legal certainty, predictability and cost-efficiency.
- Increased digitalisation.
- Improved coordination.
- Reinforcing international cooperation.
The new measures are:
- Enhanced digitalisation.
- Possibility to establish regulatory sandboxes.
- Definition and recognition of well-established technologies.
- New legal basis for notified bodies and manufacturers to conduct structured dialogue pre-and post-submission.
- 10a: Special IT Tool for reporting of interruption of supply or discontinuation, methodology to identify likely shortages.
The Digital Omnibus
On 19 November 2025, the European Commission has published a Digital Omnibus introducing targeted changes to the EU’s digital regulatory framework, including amendments of a number of digital legislations including General Data Protection Regulation (GDPR) and the ArtificiaI Intelligence (AI) Act.
The initiative aims to reduce administrative burdens, improve coherence across EU rules, and support innovation, but has also attracted criticism from a range of actors that question whether it sufficiently preserves strong protections for safety, fundamental rights, and cybersecurity.
Several actors have been calling for reform, as the EU digital legislation remains fragmented. BioMed Alliance has also raised concerns that the GDPR is still interpreted differently across Europe, putting in place concrete barriers to the sharing of data. However, the right balance has to be struck to ensure that safeguards are upheld and the privacy of citizens is protected. While the proposal claims to address these issues, some stakeholders have expressed concern that it may afford too much weight to industry perspectives.
At EFORT, we consider that it is our responsibility to operate at the European level and engage into those discussions, though they seem far from daily practice, in order to contribute and shape the policies. We do this through direct involvement in expert groups or through the Biomedical Alliance.
Interested to join? A question? Contact us at eu@efort.org
