EMA Human Regulatory Update on Medical Devices

8 December 2022 – the EMA updated guidance on medical devices.

EMA has distinct regulatory responsibilities per category of medical device, including in vitro diagnostics. They are as follows:

  • Medicines used in combination with a medical device ─ EMA assesses the safety and effectiveness of medicines used in combination with a medical device. This is part of a centralized procedure application for the medicinal product.
  • Medical devices with an ancillary medicinal substance ─ the notified body must seek EMA's scientific opinion on the quality, safety, and usefulness of the ancillary medicinal substance in three cases: if the ancillary substance is derived from human blood or plasma; if it has been previously evaluated by the EMA; or if it falls within the mandatory scope of the centralized.
  • Companion diagnostics ('in vitro diagnostics') ─ the notified body must seek EMA's scientific opinion on the suitability of the companion diagnostic to the medicinal product if the latter falls within the scope of the centralized.
  • Medical devices made of substances that are systemically absorbed ─ the notified body must seek the scientific opinion of a competent authority. The EMA provides scientific opinions on the compliance of the substance with the requirements laid down in Annex I to Directive 2001/83/EC.
  • High-risk medical devices ─ EMA supports the medical device expert panels that provide opinions and views to notified bodies on the scientific assessment of certain high-risk medical devices and in vitro diagnostics.
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