The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
Known for its relatively relaxed regulations on companion diagnostics (CDx), the European Medicines Agency (EMA) is not expected to provide guidance on the products until it has more experience in this area, an expert says. Once it does, the regulation of CDx in Europe is likely to change under an upcoming revision of the European Commission’s in vitro diagnostic (IVD) directive. The revision would make CDx Class C devices and require notified body involvement for review of technical documentation, Bruno Flamion, former chair of the EMA’s Scientific Advice Working Party, said at the Next Generation Summit in Washington, D.C., Aug. 22. Clinical Trials Advisor