Regulatory Affairs & MDR for medical devices

Regulatory affairs is the discipline that turns a working product into a marketable one. Under the MDR it begins with classification per Annex VIII — which determines effort, cost and whether a notified body is involved at all. Then follow technical documentation per Annexes II and III, clinical evaluation, risk management to ISO 14971, conformity assessment, and post-market obligations: surveillance, trend reporting, PSUR, vigilance.

The effort has grown since 2021, and unevenly. Products that passed class by class under the old directive are now classified higher; clinical data based on equivalence is scrutinised more closely; and there are fewer notified bodies than demand requires, which creates waiting times. Anyone planning certification as the final step is planning wrongly.

The providers listed here cover different roles: consulting and authoring technical documentation, clinical evaluation, acting as the person responsible for regulatory compliance under Article 15, or serving as authorised representative. When filtering, check whether someone advises or actually assumes responsibility — those are two very different contracts.