Other regulatory matters carried out at JAZMP in accordance with law on the field of medical devices.
- JAZMP provides expert advice based on an application by the applicant in relation to:
• the translation of the instructions for use and labelling of medical devices.
• the differentiation between medical devices and other products.
• the classification of medical devices
More information is available on the link to Expert advice.
- Applications for national derogation procedures according to Article 59 of Regulation (EU) 2017/745 and Article 54 of Regulation (EU) 2017/746
By way of derogation from Article 52 of Regulation (EU) 2017/745 or Article 48 of Regulation (EU) 2017/746 any competent authority may authorise, on the duly request, in the territory of the Member State, placing on the market or putting into service, a specific device for which conformity assessment procedures have not been carried out but use of which is in the interest of public health or patient safety or health.
Instructions and necessary documentation for submission of an application can be found on the Non-compliant medical devices link.