In the MDR iceberg (3)
210 days for an opinion on device-drug products
Under the MDR as under the MDD, Products which are device-drug combinations (whatever the proportion of the drug) must obtain an ‘opinion’ from a medicinal products authority designated by a Member State or the European Medicines Agency. No change here from MDD to MDR.
Verification and Validiction
Are you confused?
You are in good company: so are many others. ISO 9000 (the bit not read by many) defines: Verification: confirmation, through the provision of objective evidence, that specified requirements have been fulfilled Validation: confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled
In the MDR iceberg (2)
Person responsible – a job for life?
Manufacturers small and large must have a ‘person responsible’ (with a variation for micro and small enterprises). This person needs to know the legal requirements and the technology of the product being manufactured. Many manufacturers have such a person, but for those who do not, their head count could rise by one.