New executive orders and guidelines on medical devices

For instance, medico companies should be aware of the following executive orders and guidelines which are either updated or have been issued as new legislation/new guidelines.

• Executive order on medical devices and products without an intended medical purpose
• Executive order on importers and distributors of medical devices and products without an intended medical purpose
• Executive order on the scientific and ethical principles of clinical testing of medical devices, etc.
• Executive order on fees for medical devices and products without an intended medical purpose
• Executive order on fees for importers and distributors of medical devices and products without an intended medical purpose
• Guidelines on the labelling and instructions for medical devices
• Guidelines for manufacturers about reporting incidents regarding medical devices
• Guidelines for manufacturers about software and apps for medical devices and in vitro diagnostic medical devices
• Guidelines for newly established manufacturers of medical devices
• Guidelines for applying for authorisation for clinical testing of medical devices
• Guidelines for importers and distributors of medical devices
• Guidelines for distributors of medical devices

Plesner will continue to keep an eye on the interpretation of the obligations under the new regulation on medical devices. Please contact us if you need advice on what the new regulation means for your company.

You can read more about the new regulation on medical devices here.