fact not factoid

Let me Google this for you!


A. (from BSI Website) “MEDDEV 2.4/1 Classification of Medical Devices” is the guidance document for classification.

Section 3.5 Handling of Interpretational problems: “In case the manufacturer is unsure how its devices should be classified, it should first consult a Notified Body.
In case doubts remain or there is a disagreement with the Notified Body, the relevant Competent Authority (i.e. the Competent Authority to which the notified body is subject) should be approached in accordance with Article 9 of Directive 93/42/EEC.”


B. (from EU Commission website) 93/42/EEC is the EC Directive for Medical Devices
Article 9, bullet point 2: “In the event of a dispute between the manufacturer and the notified body concerned, resulting from the application of the classification rules, the matter shall be referred for decision to the competent authority to which the notified body is subject.”




C. 93/42/EEC Annex I at 7.4 paragraph 1 and 2: “Where a device incorporates a substance which may be considered........action ancillary.........the notified body shall........seek a scientific opinion from EMA......on the quality and safety..........when issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.


Looks like its set in stone!!!