Several times per week we solve this particular problem. The diagnosis 🔍: The first user registering a company often does not have suffi...
Transition to the new “EU REP” Symbol!
The European regulatory landscape for medical devices continues to evolve. A key recent development is the formal transition from the long-esta...
EUDAMED advice for free! We bust EUDAMED myths 💡
Numerous misunderstandings exist around EUDAMED. We are happy to share and clarify them for you! Exemptions and further aspects may apply...
MDSS’ EUDAMED Updates!
EUDAMED playground: MDSS’ SRN is DE-AR-000030861 The EUDAMED playground is a useful tool for testing and training EUDAMED registration...
Selling into the EU? Understanding Packaging and EPR Obligations Under PPWR
The EU Packaging and Packaging Waste Regulation (PPWR) will become applicable on 12 August 2026 and will replace the current Packaging and Pack...
Team-NB Position Paper on the Transfer of IVDR Formal Applications and Surveillance of Legacy Devices
On 10 June 2026, the European Association of Medical Devices Notified Bodies (Team-NB) adopted a new Position Paper entitled: “Agreement Related...
🚨 Key Deadline Approaching: MHRA Annual Fee (30 June 2026)
Stay ahead and keep your UK market access uninterrupted — the MHRA Annual Fee deadline for April 2026 – March 2027 is fast approaching! &n...
📢 Pre market medical devices regulation – stakeholder impact survey
The Medicines and Healthcare products Regulatory Agency has an Open call for evidence on proposed changes to pre-market regulatory requireme...
MHRA Updates Guidance on Modifications to Clinical Trial Approvals
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance “Clinical Trials for Medicines: Modifying a Cl...
FDA Updates Guidance on Exemptions for Certain Unclassified Medical Devices from Premarket Notification Requirements
The U.S. Food and Drug Administration (FDA) has issued an updated guidance document, “Intent to Exempt Certain Unclassified Medical Devic...
