Changes from report parliamentary committee draft to plenary report

AddedAnnex V – paragraph 1: The manufacturer shall correctly determine the product type pursuant to Article 3, point 31, and the corresponding product category on the basis of the applicable harmonised technical specification. Where a notified body is involved in assessment and verification, the notified body shall verify these determinations.

RemovedAnnex III a (new): Annex IIIa / Procedure for adopting a European Assessment Document / 1. Work programme / In cases as covered in Points 1(a) and 1(b), after agreement with the manufacturer and the Group respectively, the organisation of TABs shall inform the Commission of the work programme for drawing up the European Assessment Document, the schedule for its execution and indicating the assessment programme. This communication shall take place within 3 months of receipt of the request for a European Technical Assessment by a TAB, which shall initiate the procedure as laid down in Points 1(a) and 1(b) in this annex. / In the cases covered in Point 1(c), the organisation of TABs shall submit to the Commission the work programme for drawing up the European Assessment Document with the same content and within the same deadline as indicated above for cases in Points 1(a) and 1(b). After that, the Commission shall communicate to the organisation of TABs within 30 working days its observations on the work programme to proceed with the process. The responsible TAB or the organization of TABs, respectively, after having been given the opportunity to comment, shall amend the work programme accordingly. / In the cases covered in Point 1(d), the organisation of TABs shall inform the Commission of the work programme for drawing up the European Assessment Document, the schedule for its execution and indicating the assessment programme. / 2. The draft European Assessment Document / The organisation of TABs…

AddedAnnex V – point 1 – point b – introductory part: (b) The notified body shall issue the certificate of constancy of performance and of conformity on the basis of:

RemovedTo 1.: Information and confirmation from the COM on the work programme is important for the development of the EAD by EOTA.

AddedAnnex V – point 1 – point b – point ii: (ii) an assessment of the performance of the product on the basis of type testing (including sampling of the item(s) to be taken as representative of the type), type calculation or tabulated values or documentation describing the product and, in all these cases, review of the documentation of the product;

RemovedTo 3.: The COM may ask to modify, but not to abandon, as the request for an EAD shows that there is a need for it.

AddedAnnex V – point 1 – point c: (c) The notified body shall provide continuous surveillance, assessment and evaluation of factory production control.

RemovedTo 4.: The evaluation of the insights gained from the consultation of MS is a competency of the COM, which is why the organisation of TABs needs to be informed in case changes are agreed between the COM and the MS that concern the development of the EAD.

AddedAnnex V – point 2 – point b – introductory part: (b) The notified body shall issue the certificate of constancy of performance and of conformity on the basis of:

RemovedTo 6.2.: Speeding up the process ensures planning security.

AddedAnnex V – point 2 – point c: (c) The notified body shall provide continuous surveillance, assessment and evaluation of factory production control.

RemovedTo 7: Where a previous version of an EAD is superseded by a newer one, it is important to establish a coexistence period. In this way, manufacturers and notified bodies, have the time to adapt to new conditions as the may have to adapt their manufacturing process or apply for re-issuing of an ETA, or apply for a relevant notification

AddedAnnex V – point 3 – point c: (c) The notified body shall provide continuous surveillance, assessment and evaluation of factory production control.

RemovedAnnex V – point 1 – point b – point ii: (ii) an assessment of the performance of the product on the basis of type testing performed by a notified testing laboratory (including sampling of the item(s) to be taken as representative of the type), type calculation or tabulated values and, in all these cases, review of the documentation of the product;

RemovedAnnex V – point 2 – point b – point ii: (ii) an assessment of the performance of the product on the basis of type testing performed by a notified testing laboratory (including sampling of the item(s) to be taken as representative of the type), type calculation or tabulated values and, in all these cases, review of the documentation of the product;

Annex V – point 5 – point a – point i: deleted

Change 181

ChangedAnnex V – point 5 – point b – point i: (i) assessan assessment of the performance on the basis of testing performed by a notified testing laboratory (based on sampling carried out by the manufacturer), calculation, tabulated values or descriptive documentation of the construction product;

Change 182

AddedAnnex V – point 5 – point b – point ii: (ii) confirmation of the correct determination of the product type and of the product category.

AddedAnnex V – point 7 – point a – introductory part: (a) In the case of systems 1+, 1 and 2+, inspection of the manufacturing plant shall cover the entire technical part of the plant, at least with regard to the following element, which shall ensure a continuous orderly manufacturing process:

AddedAnnex V – point 7 – point a – point i: (i) the factory production control specifying the measures and frequencies foreseen to ensure constancy of performance, including the critical to performance parameters;

AddedAnnex V – point 7 – point a – point ii: deleted

AddedAnnex V – point 7 – point a – point iii: deleted

AddedAnnex V – point 7 – point b: (b) Factory production control shall cover the process from receipt of the raw materials and components to the dispatch of the product once the production has started (‘gate to gate’ approach) and include as a minimum the critical to performance parameters. In the case of systems 1+, 1 and 2+, the notified body shall assess whether this process is designed and optimised in view of the goal that the products conform with the product type and therefore reach the performances declared in the declaration of performance and are compliant with the requirements set out in or under this Regulation.

AddedAnnex V – point 7 – point d: (d) In the case of system 3+, verification shall consist of the verification of all calculations and input data. In that context, the notified body shall verify whether the applicable rules on modelling and calculation laid down in the applicable harmonised technical specification or methodology provided by the Commission are followed and whether the calculation model and input data reflect the production process. In case a verified IT tool or one provided by the Commission is used, the verification shall focus on the correct use of the tool. Where secondary data is used, the notified body shall check whether the correct data sets, prescribed by applicable product specific calculation rules contained in the applicable harmonised technical specification or the methodology provided by the Commission, are used. Where company-specific data is used, the reliability of that data shall be verified. To that end, the notified body may undertake an audit of the manufacturing plant to which the data refer, and shall examine documentation to verify the reliability of the data. The notified body may extend this examination to key parts from suppliers who are obliged to cooperate in accordance with Article 30.

AddedAnnex V – point 7 – point f: (f) Where, in the case of system 1+, 1 , 2+ or 3+, there is evidence that the manufacturer has not performed his task properly or the product performances do not comply with the declared performances, the notified body shall refuse issuing a certificate for at least one year or withdraw the certificate whilst permitting issuing a new one only after the deficiencies have been remedied.