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Provision history · PPE Regulation

Art. 41b · Prioritisation of the conformity assessment of PPE designated as crisis-relevant goods

Personal Protective Equipment Regulation · 32016R0425 · every version of this act · on EUR-Lex

1 change recorded across 1 version, newest first.

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Version in force Inserted +1,032 −0

Amended by Regulation (EU) 2024/2748 32024R2748 on EUR-Lex

Applies from: not readable (an inserted provision states its own application date only in prose) why

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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

v1 is the previous version, v2 this one.

Text from EUR-Lex

Inserted in this version 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.