The January MDEG meeting also saw a substantial revision of MEDDEV 2.
Following two years' worth of development, guidelines covering qualification and classification of software for healthcare applications related to medical devices were also released as part of the MDEG meeting; these guidelines address software for the following uses:
The MDEG meets regularly to discuss common issues and discusses the drafting of new guidance documents.
Essentially, the NBOG identifies and communicates "best practices" for notified bodies and reports on their progress at the semi-annual meeting of the Competent Authorities and the MDEG.
These items also can be elevated to MEDDEV status if they are approved by the MDEG.
After the directive was published, MDEG stakeholders realized that some points in the directive needed clarification and subsequently published a guidance document on Jan.