The European Commission’s new health package, announced end of December 2025, sets out an ambitious vision for a more innovative, competitive, and resilient EU health ecosystem. Centred on the Biotech Act, revised Medical Device Regulations, and the Safe Hearts Plan, it promises to boost innovation, streamline regulation, and improve cardiovascular health.

However, beneath the rhetoric, implementation challenges loom large. The Biotech Act aims to accelerate biotech innovation and market access, yet persistent fragmentation, funding gaps, and weak translational frameworks raise doubts about its real-world effect. Without structural alignment across Member States, ambition may outpace feasibility.

The Medical Device reform seeks efficiency and regulatory coherence, projecting significant savings. Still, simplification within complex oversight systems seldom comes easily, and smaller firms may face additional compliance pressures despite the intended relief.

The Safe Hearts Plan finally acknowledges cardiovascular disease as a critical EU priority. While its focus on prevention, data and AI is timely, Europe’s limited interoperability and uneven trust in digital health suggest a cautious outlook.

Together, these initiatives mark a necessary step forward—but without stronger coordination, resources, and pragmatic execution, their impact may remain more visionary than transformative.

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Fine-Tuning the MDR? What the New Article 74 Proposal Means for PMCF Investigation

The latest proposal to amend Regulations (EU) 2017/745 and 2017/746 aims to recalibrate how evidence under Art. 74  is generated for medical devices, with a particular focus on clinical data and post-market activities.

Such a proposal from the European Commission marks the formal start of an EU legislative amendment process, signalling a clear political and regulatory intention to adjust and clarify how the MDR and IVDR are to be applied in practice.

A recent clarification of the MDR rules for PMCF investigations shows how precisely the Regulation is being fine-tuned. For regulatory and clinical teams, it is worth taking a closer look at the detailed changes.    

Clearer link to the PMCF plan    

In the revised wording, PMCF investigations must now be conducted “in accordance with its PMCF plan”. This makes it more explicit that additional invasive or burdensome procedures cannot be planned in isolation but must be consistently embedded within the PMCF plan.    

More precise documentation requirements    

Instead of referring broadly to “Chapter II of Annex XV”, the new text narrows the required documentation down to “Chapter II, Sections 1, 3 and 4, of Annex XV”. This sharpens the focus of the submission: not the entire chapter, but clearly defined parts are required for the notification of PMCF investigations.    

More accurate allocation of legal provisions    

The references to applicable articles are now more granular: Article 62(4), points (b) to (k) and (m), Article 75(1), Articles 76 and 77, and Article 80(5) and (6). At the same time, it is clearly stated that these requirements apply specifically to PMCF investigations involving additional invasive or burdensome procedures. This improves legal certainty for sponsors planning such studies.    

In practice, this means that while the legal text appears more precise on paper, it still leaves manufacturers navigating an unresolved tension between the MDR’s wording and evolving guidance, with the actual level of evidence expected by notified bodies remaining opaque.    

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MEDIACC is also involved in the group that is authorised to propose further optimisations and close the remaining regulatory gap for clinical investigations of medical devices.

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They have done it!! EU Commission's new proposal for MDR

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As promised and in time, the latest proposal to amend Regulations (EU) 2017/745 and 2017/746 aims to recalibrate how evidence is generated and used for medical devices, with a particular focus on non-clinical data and post-market activities.    

Such a proposal from the European Commission marks the formal start of an EU legislative amendment process, signalling a clear political and regulatory intention to adjust and clarify how the MDR and IVDR are to be applied in practice. We will have to read the text carefully and find the way from interpretation.    

For many devices that are not classified as high risk, safety and performance may be demonstrated adequately on the basis of non-clinical data, including new approach methodologies (NAMs). In this context, the proposal seeks to give greater prominence to the possibility of relying on such non-clinical evidence within the conformity assessment under Regulation (EU) 2017/745.    

Clinical data are frequently available for devices that are equivalent to the product undergoing conformity assessment. To make it easier for manufacturers to rely on equivalence, the current requirement in Regulation (EU) 2017/745 for a contractual agreement with the manufacturer of the equivalent device, granting access to its technical documentation, is to be removed and the equivalence criteria adjusted accordingly.    

Post-market clinical follow-up (PMCF) remains a key obligation under Regulation (EU) 2017/745, as it is essential for detecting safety issues that may arise during real-world use. In order to reduce the reporting burden, the proposal allows manufacturers to integrate PMCF findings directly into the updated clinical evaluation, rather than preparing additional, separate reports. It remains unchanged that post-marketing surveillance may only be waived in justified cases.   

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The Evaluation of the Medical Device Regulation (MDR), published yesterday, the 16.12.2025, spans nearly 200 pages — a reflection of both progress and complexity.

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The MDR was introduced to address key issues: insufficient safety of medical devices, barriers within the EU internal market, and fragmented or incomplete data.

Over the years, the number of clinical investigation applications has remained stable, with around 85% approved. However, variations between countries persist, prompting calls for a central EU structure to coordinate multi-national clinical investigations and improve transparency. Encouragingly, research-related studies and post-market clinical follow-ups have increased, signalling ongoing innovation and stronger clinical evidence.

While the new post-market surveillance and vigilance systems have enhanced coordination and safety monitoring, gaps remain. Resource constraints and uneven implementation still limit the full potential of the MDR framework — but the direction of travel is clearly positive.

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We are proud to announce that Caroline Schmidt-Lucke has been appointed as an expert on the international committees ISO/TC 194 and NA 027-07-20 AA for “Clinical Investigations” (ISO 14155). Our goal is to open doors for innovative clinical trials based on established standards.

The updated ISO 14155:25 standard sets the global standard for clinical investigations of medical devices and digital health applications. ISO/TC 194 standardizes the approach for the biological and clinical evaluation of medical and dental materials and products, including the development of biological testing methods for these products, and the establishment of principles of good clinical practice for clinical trials of such products in humans. It plays a key role in ensuring high-quality clinical data and supporting secure and reliable market access in Europe.

Working closely with global experts will help drive innovation and consistency on the European market as well and strengthen trust and cooperation between manufacturers, partners and regulators worldwide.

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The digital transformation in European healthcare is progressing at very different speeds. As the Deutsche Ärzteblatt points out, “other European countries are significantly ahead of Germany in digitizing their healthcare systems. Estonia has had a functional electronic health record for years, and in Finland, the population regularly uses digital health applications. ”

In Finland, patients routinely receive digital medical advice, and health data is stored electronically. One specific example is the EMOM app for gestational diabetes, which combines blood sugar measurement, activity tracking and a digital food diary. Clinical studies have shown that the app can improve fasting blood sugar, increase physical activity, and reduce both pregnancy weight gain and the rate of macrosomic babies, while saving clinical resources. AI is currently being developed to further improve these results.

Estonia's electronic health record, which has been available to all citizens since 2008, requires hospitals and practices using public health insurance to share important information via the system. Emergency personnel can access patients' medical history in real time. The system has been further developed to focus less on free text and more on structured data and supports both healthcare and research.

Countries such as Estonia and Finland show that digitization is successful when robust governance, interoperability, and evidence-based digital tools are a priority. As Germany moves forward with its own digital health strategy, it will be crucial to learn from these pioneers in order to exploit the full potential of digital medicine.

The promise of decentralised and hybrid clinical trials is no longer speculative—it is here, and it is reshaping how medical device studies are designed, conducted, and monitored. Yet for many sponsors, the leap from traditional site-centric models to AI-enabled, patient-centric designs remains a daunting regulatory and operational puzzle. At MEDIACC, we are closing that gap.

Under the Medical Device Regulation (MDR) and ISO 14155:2020, clinical investigations must demonstrate robust performance and safety data, often requiring adaptive, real-world evidence generation. The EU AI Act Adds another layer: AI systems used in trial conduct—whether for automated monitoring, risk-based quality assurance, intelligent visit scheduling, or continuous analysis of wearable-generated data—are now classified by risk. High-risk AI demands conformity assessment, human oversight, and transparent governance before deployment. This is not a barrier; it is a framework for trustworthy innovation.

We currently translate these complex requirements into actionable strategy. Sponsors need support transitioning from classical trials to decentralised models, ensuring MDR compliance while integrating AI-driven efficiencies. Designing fully digital or hybrid protocols leverage remote monitoring and digital endpoints without sacrificing data integrity or patient safety.

But technology alone is insufficient. Sites must be equipped to interpret AI-generated signals, distinguish meaningful anomalies from noise, and maintain ISO 14155-compliant oversight. That is why tailored training concepts are needed: teaching investigators and clinical research staff how to read, evaluate, and act upon AI-augmented monitoring outputs within a robust quality management system. And additionnally, all results must be measurable.

The future of clinical research is decentralised, digital, and intelligently automated. As CRO Partner, MEDIACC ensures that transition is not merely theoretical but routine, compliant, and scientifically rigorous. Let us discuss how your next study can move from Blueprint to Breakthrough.

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Imagine this: A diagnosis that changes your life forever. But what if there was soon a weapon against cancer that doesn't just protect — it heals?

💉 The good news is here: Research into Cancer Vaccinations is making giant leaps. Not the classic vaccination to prevent disease — but personalised therapies that mobilise the body's own immune system against already existing tumours. That's revolutionary.

The Breakthrough with mRNA Technology

🧬 The same technology that saved lives during the COVID-19 pandemic is now showing impressive results in oncology. mRNA vaccines “train” the immune system to specifically recognize and fight cancer cells. Particularly exciting: early clinical trials show that patients whose immunotherapy is combined with mRNA vaccines live significantly longer — even with tumours that have been difficult to treat so far. Even if the term vaccination is commonly used, one would prefer to speak of antigen-based immunotherapies rather than vaccines in order to avoid confusion with vaccinations against infectious diseases and with vaccines against cancer-inducing viruses. Furthermore, “cancer vaccines” do not protect against cancer, but rather combat it when it is already present.

Personalized Rather Than One-Size-Fits All

🎯 The future thinks individually. Scientists are developing bespoke vaccines specifically adapted to the unique mutations of a tumor. The potential: more effective treatments, fewer side effects, better quality of life.

A Beacon of Hope for Millions

💪 Cancer vaccinations could fundamentally redefine oncology — from fighting recurrence to preventive applications. Whilst research continues intensively and regulatory hurdles remain to be overcome, one thing is clear: we are at the beginning of a new era in cancer treatment.

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The new Prognos study commissioned by the Federation of German Industries (BDI) presents impressive figures: Innovations in the area of medical devices can save up to 9 billion euros annually in the German healthcare sector — through outpatient care, AI-based diagnostics, robot-assisted systems and intelligent materials such as 3D printing.

That is more than just cost efficiency. It is a signal to health policy: Innovation is not a luxury, but a necessity. The question is not whether we can afford innovations in medical devices — but whether we can afford to block them. The highest savings potential lies in outpatient care, where almost 3 million cases could generate savings of over 6 billion euros.

Where is the challenge?

While the economic potential is clear, the complexity of regulation is growing with strict requirements for transparency, safety, and clinical evidence. High-risk medical devices require robust data quality, documented human monitoring, and continuous performance monitoring.

This is not an obstacle, but the basis for trust.

Manufacturers who see these requirements not as hurdles but as quality features will establish themselves on the market. They will win over patients, doctors and payers because their products are not only innovative, but also evidence-based and trustworthy.

At MEDIACC, we support manufacturers in exactly this: from study planning to generating clinical evidence to conformity assessment in accordance with the Medical Device Regulation (MDR), the In Vitro Diagnostics Regulation (IVDR) and the Artificial Intelligence Regulation (AI Regulation). Because solid regulation and innovation go hand in hand.

The message is clear: The future of healthcare lies in the intelligent combination of regulatory excellence and economic efficiency.

❓ How do you navigate your path to regulatory compliance with innovative medical devices?

#Innovation #Medizinprodukte #Medizinprodukteindustrie #ZukunftderMedizin #KlinischeStudien

COVID-19 is no longer the monster of 2020 — but it's not a harmless cold either. 🦠 The level of danger is now at the level of influenza. Why should we take them both seriously?

Here are the facts:

 🔹 Similar risks: Both viruses affect similar risk groups. COVID-19 is just as dangerous as the flu today.

 🔹 STIKO recommendation: Booster vaccinations for everyone aged 60 and over, previous patients and nursing staff. Why Because vaccination protects against severe cases!

 🔹 Study document: A Danish study involving almost 900,000 people over 65 years of age shows that booster shots work!

 🔹 Current data: Hospitalizations and deaths from COVID-19 and influenza are comparable. (data up to week 35, season 2024/2025)

 🔹 Vaccination quotas: Only 20.9% of people over 60 years of age have been vaccinated against COVID-19 — compared to 38.2% for the flu vaccination. Too little! 😮

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Conclusion: COVID-19 and influenza are both dangerous. Particularly important for risk groups. 💪

 #Gesundheit #Impfen #COVID19 #Influenza #KlinischeWissenschaft

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