Has there been formal agreement by the Commission Working Group Pressure of the design of the PMA Form and its contents?
No. The UK Notified Bodies Group are drafting a standard form for submission to the European Notified Bodies Forum meeting in September 2001 and then to the Commission Working Group Pressure. There is currently no standardised format for a PMA form, therefore at the present time it is by agreement between the manufacturer and the notified body. Question BVAMA 7/F BVAMA PED Forum 28th March 2001 Question related to : Annex I, section 4.2. Question asked by : Bob Merrifield of Hindle Cockburns Question : Can a PMA for Category III and IV products be reviewed by a Notified Body independently of the Design File/Manual Answer : It depends upon the notified body who is in charge of the manufacturers conformity assessment procedure. BSI said that if the scope of the PMA encompasses the intended application or range of applications/service, then the PMA does n not have to be accompanied by the technical file for approval by the notified body. Lloyds said the PMA to be performed with the design
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- Has there been formal agreement by the Commission Working Group Pressure of the design of the PMA Form and its contents?
