Digital(AI), In-vitro & Medical Devices

Regulates products, services, or solutions that prevent, diagnose, monitor, treat, and care for people.

Regulates non-invasive tests used on biological samples (for example, blood, urine, or tissues) to determine the status of a person’s health.

Regulation (EU) 2024/1689 of the European Parliament laying down harmonized rules on artificial intelligence and amending other relevant regulations.

 In 1982, the US FDA that regulated medical devices and radiation-emitting products merged to form the Center for Devices and Radiological Health (CDRH).

Quality policy. Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization.

The agreement on mutual recognition concerning conformity assessment certificates and markings, MHRA has with the EU, US, Canada, TGA & New Zealand.

Medical devices — Quality management systems — Requirements for regulatory purposes

Quality management systems – Requirements

The Medical Device Single Audit Program allows to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.

Part 1: Evaluation and testing within a risk management process.

Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices.

Part 1: Requirements for materials, sterile barrier systems, and packaging systems.

Part 1: Classification of air cleanliness by particle concentration

Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration

General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

Application of risk management to medical devices.

Symbols to be used with medical device labels, labeling and information to be supplied - Part 1: General requirements.

General requirements for the competence of testing and calibration laboratories.

Medical device software, software life cycle processes.

Application of usability engineering to medical devices