EU

EU medical device consultant Trevor Lewis takes note of the recent, if belated, progress towards the building of the post-MDR playing field for medical device companies in Europe, but calls political decision-makers and economic operators to account: getting it right is nothing short of a matter of life and death, he tells In Vivo.

When a medtech regulatory consultant receives some 500 requests in a single month on LinkedIn for a guide he has spent 300 hours writing, you know it is a critical topic.

At last, there is more transparency for medtech manufacturers about testing and certification costs. But BSI is still the only notified body to have published lead times under the medtech regulations.

Without new tools, cyber security risks related to the increasing digitization of healthcare will remain unmonitored and under-researched, a new report warns.  

With the latest ruling in Germany, there is speculation that the Medical Device Regulation’s confusing Article 11 on software or the device’s timing of gaining its class I category may be to blame for the invidious position Dermanostic has found itself in.

Harmonization through increased centralization was a key theme that ran through a recent discussion between Erik Vollebregt and Tom Melvin about the MDR. Both agreed that far-reaching short-term changes are not only possible but vital.

In this third article of a series on new drug reimbursement recommendations by the HTA body NICE, the Pink Sheet finds that fewer innovative medicines are reimbursed in England than in eight other European nations.

The need for the EU to foster the development of orphan devices, intended for smaller patient populations with less commercial promise, is well documented. At last, action is starting.

Many in the EU will be taking their traditional summer break in August. They will be leaving much in the political and regulatory melting pot as they go.

England’s NICE has “misclassified” HER2-low metastatic breast cancer as a medium severity disease, say AstraZeneca and Daiichi Sankyo, the co-developers of Enhertu. NICE said it would consider a rapid re-appraisal if the companies offered a “fair price” for the drug.

Having already voiced their commitment to working to resolve issues with the implementation of the MDR and IVDR, the national competent authorities for medical devices around the EU are now also calling for a longer-term view.

Dr Peter Liese and Dr Vytenis Andriukaitis, both familiar names when it comes to the regulation of medical technology in the EU, have been elected as MEPs at a time when the EU’s medtech regulations are being targeted for urgent change.

The implementation phase of the European Health Data Space is an opportunity to address “critical aspects” of the new regulation that require clarification, says pharmaceutical industry federation EFPIA.

In the EU, developers struggle to tell potential investors how many trials a device might require, the potential duration or associated costs. Tom Melvin explains how to tackle these issues in a third piece* based on a recent interview.

The draft guidance addresses specific requirements for oligonucleotide-based medicines that are not answered in existing guidance documents, and has been two years in the making.

The EU needs to conduct a deeper, more decisive analysis of its medtech regulatory problems before it decides how to adopt elements of MEP Peter Liese’s proposed amending regulation, regulatory expert Tom Melvin told Medtech Insight.

Evidence generated through an EU public-private funding initiative has resulted in a new biomarker method for measuring the level of Alzheimer’s disease in a person’s brain, which drug developers can use during clinical trials.

Medical device regulatory reliance and recognition of third-party regulators’ approvals have been making news in the UK, but in certain other markets the practice is well established. International regulatory experts explained their experiences at the MedTech Forum 2024.

With the axe falling on a growing number of essential legacy products, Tom Melvin explains why a plan around derogations for devices falling through the regulatory crack is now critical.

Early and comprehensive reform of the MDR and IVDR is critical to address overregulation and unpredictable medtech regulatory processes, medtech tells reelected Commission President.