Recital 13

(13) Given that the essential safety requirements harmonised by the amended Regulations will remain applicable and that it should be possible for a national competent authority to issue the authorisation for placing products on the market without the CE marking exceptionally, temporarily and in addition to the conformity assessment procedures laid down in those Regulations, this Regulation continues to improve the conditions for the functioning of the internal market. This Regulation takes into account both the context constituted by the fully harmonised rules stemming from the existing Regulations and the complementary rules stemming from amendments that this Regulation makes to them. Those amendments would allow national authorities to recognise authorisations issued in other Member States and require the Commission to extend the validity of such national authorisations from the territory of a single Member State to the territory of the Union, by means of implementing acts, provided that the requirements set out in the authorisation ensure conformity with the essential requirements laid down in those amended Regulations. Such a parallel national authorisation scheme in exceptional times of crisis, in addition to the Union conformity assessment procedure, is justified and proportionate for the achievement of the legitimate objective of protecting the health, life and safety of persons. By not providing for an automatic mutual recognition of each national authorisation that derogates from conformity assessment procedures in times of crisis, this Regulation aims to avoid any circumvention or undermining of the CE marking procedure and thereby aims to maintain consumer confidence in the safety of products in the Union market bearing the CE marking. Therefore, those new derogating rules, insofar as they prohibit affixing the CE marking to products which have been approved only at national level, should not affect the harmonised product legislation and consumer confidence in CE marking, which can only be affixed where all the harmonised substantive and procedural rules have been respected. By providing an additional, parallel avenue for exceptionally placing crisis-relevant goods on the market in the context of an internal market emergency, the derogating rules enable new manufacturers to swiftly place their products on the market without waiting for the finalisation of the normal conformity assessment procedures. Such an accelerated and exceptional placing on the market would contribute to the swift increase in the supply of crisis-relevant goods, and at the same time facilitate manufacturers as it would allow them to place initial batches or series of products on the market before the completion of the conformity assessment procedures. Once the conformity assessment procedures have been successfully completed, subsequent batches or series of products should be fully compliant with the relevant applicable rules and thus benefit from free movement. The co-existence, during an internal market emergency, of an exceptional, derogating set of rules alongside the ordinarily applicable rules makes it possible to transition to the ordinarily applicable rules, enabling the manufacturers to continue placing their products on the market after the expiry or deactivation of the internal market emergency mode.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-17 · Text as adopted (Official Journal); later amendments are not incorporated in this text.