rec_3

(3) The substitution of MCPs as components with alternative detectors is not viable under conditions where extreme miniaturisation, very short response times or very high signal multiplication factors are required. The use of lead in those cases where the performance and specific features of MCPs exceed alternative detectors should therefore be exempted from the prohibition. As currently no lead-free alternatives are in sight, pursuant to Article 5(2) of Directive 2011/65/EU, the validity period of the exemption should be 7 years from the relevant compliance dates for medical devices, monitoring and control instruments, in vitro medical devices and industrial monitoring and control instruments, as laid down in Article 4(3) of Directive 2011/65/EU. In view of the innovation cycles for all medical devices and monitoring and control instruments 7 years is a relatively short transition period which is unlikely to have adverse impacts on innovation.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-14 · Text as adopted (Official Journal); later amendments are not incorporated in this text.