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.
The MDR (IVDR) provide an exclusion for micro and small enterprises. The Regulation text states: ‘micro and small enterprises… shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person permanently and continuously at their disposal’. Priory Analysts offers this service to such enterprises, although the words ‘permanently and continuously’ are taken not to mean a contract of infinite duration… (‘permanently’).