MDEGMedical Devices Expert Group
MDEGMedium-Duty Engine Generation (automotive industry)
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deg[disjunction] [ek.sup.(n)] = deg[and] [ek.sup.(n)] = 1 , deg [ek.sup.(n)] = k and mdeg [ek.sup.(n)] = n.
The simplicity of the chosen elements bi,j for these bases has two major advantages: the fact that mdeg [b.sub.i,j] = 1 (the minimum possible) and the fact that, as we will see in the next chapter, [b.sub.i,j]* [member of] {-1*, 1*}.
The January MDEG meeting also dealt with amendments to post-market clinical follow-up (PMCF) that were stipulated by Directive 2007/47/EC.
Also issued during the MDEG meeting were finalized guidelines (MEDDEV 2.5.10, Rev.
The January MDEG meeting also saw a substantial revision of MEDDEV 2.14.1 dealing with IVD classification--now a 21-page document, from eight pages in its previous iteration.
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 Clinical Evaluation Task Force (CETF), a sub-group of the MDEG Committee, composed of representatives from member states, notified bodies and industry, was established and charged with addressing these issues.
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. One member of the NBOG usually produces a written guidance, which is then circulated to the other members for comment.
These items also can be elevated to MEDDEV status if they are approved by the MDEG. An example of a NB-MED guidance document is NB-MED/2.5.2/Rec 2, titled Reporting of Design Changes and Changes of the Quality System.
After the directive was published, MDEG stakeholders realized that some points in the directive needed clarification and subsequently published a guidance document on Jan.