Posts in Knowledge Base

The MDR raised the bar on clinical evidence sharply. “It worked under the old directive” is no longer enough — every device now needs a[…]

The technical documentation is the evidence file that proves a device is safe and performs as intended. It is what a notified body assesses, what[…]

Under the EU Medical Device Regulation, everything starts with classification. Get the risk class right and the whole route to market follows logically; get it[…]

For any company bringing a medicine to Europe, one of the earliest and most consequential decisions is procedural rather than scientific: which marketing authorisation route[…]

The Pharmacovigilance System Master File is the single document that describes how a company keeps its medicines safe. When an inspector arrives, it is often[…]

What began as an urgent, industry-wide safety review of nitrosamine impurities has settled into a permanent feature of pharmaceutical quality management. The call-for-review deadlines have[…]

Cell and gene therapies are among the most promising — and most complex — medicines in development. Advanced therapy medicinal products follow a dedicated regulatory[…]

Every prescription pack in Europe now carries a unique code and a tamper-evident seal. For companies supplying Greece, the country’s late arrival to this system[…]

Pricing a medicine in Greece is not a negotiation in the usual sense — it is largely a calculation, driven by the prices of other[…]

The randomised controlled trial remains the gold standard — but it no longer stands alone. Real-world evidence is increasingly shaping both regulatory approval and reimbursement[…]