23. May 2019
The EU Commission posted a new version of the Borderline Guidance with revision 1.22 New Amendments in the current version are: Automated external defibrillator storage units If it is intended to be used with an individual AED to store it in the environmental conditions It should be considered an accessory Lubricants intended for alleviation of vaginal dryness According to Rule 5, these lubricants should be classified in class IIa Medication decision support software The software is intended to...
07. December 2017
The Borderline Working group chaired by the EU Commission published the updated Version 1.18 of the "MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES". The document is intended to act as a guidance for the interpretation of the MDD and IVD. The new paragraphs introduced by the update are identified by the pictogram "New" and include the products: Products intended to reduce the effect of alcohol Radiation shields D-mannose for the prevention of...