in force 2026-05-29 INSERTED+1,032 −0§
Amended by Regulation (EU) 2024/2748 32024R2748
applies from: unknown (an inserted provision states its own application date only in prose)
Sources disagree — the text comparison and the amending act's instructions found this change; the EU's own amendment metadata does not list it. All are shown; none is overruled.
This is a newly inserted article setting out rules for prioritising conformity assessment of PPE designated as crisis-relevant goods, covering PPE listed in the implementing act referred to in Article 41a(1) that requires mandatory notified body involvement, priority handling of applications by notified bodies regardless of lodging date, a limit on disproportionate additional costs to manufacturers from such prioritisation, and an expectation of reasonable efforts by notified bodies to expand testing capacity.
Cited: Art. 41b, v2
text before / after
inserted text (02016R0425-20260529)
Article 41b Prioritisation of the conformity assessment of PPE designated as crisis-relevant goods 1. This Article applies to PPE listed in the implementing act referred to in Article 41a(1) that is subject to the conformity assessment procedures referred to in Article 19 that require the mandatory involvement of a notified body. 2. The notified bodies shall make best efforts to process as a matter of priority all applications for a conformity assessment of PPE referred to in paragraph 1 of this Article, irrespective of whether those applications have been lodged before or after the activation of the emergency procedures pursuant to Article 41a. 3. The prioritisation of applications for a conformity assessment of PPE pursuant to paragraph 2 shall not result in additional disproportionate costs for the manufacturers who have lodged those applications. 4. The notified bodies shall make reasonable efforts to increase their testing capacities for PPE referred to in paragraph 1 in respect of which they have been notified.