Evidence-led updates

News and regulatory updates

Corporate news and regulatory information are separated, dated and linked to their authoritative source.

NOTICE joins Applus+ Laboratories

Applus+ Laboratories announced the acquisition of NOTICE on 17 July 2025, expanding its medical-device conformity-assessment capabilities.

Open authoritative source

Regulatory updates

This area will present approved updates with publication date, effective date, source and affected process.

Source-site archive The legacy announcements below are preserved to prevent content loss; they are not current MDR guidance or operating instructions.

Legacy / transitional

Extension of MDD certificates

The source-site MDD extension announcement is retained for historical and transitional reference.

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Legacy / transitional

Designation under Directive 93/42/EEC

The source MDD designation announcement is not a current statement of MDR scope.

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QMS verification pending

ISO/IEC 17065 accreditation announcement

The source announcement is preserved pending confirmation of its date and continuing public relevance.

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Historical

ISO 13485 accreditation announcement

The source referred to ISO 13485:2012 and is retained only with historical context.

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QMS verification pending

Certification methods and procedures published

The source publication notice is retained while current codes, revisions and effective dates are verified.

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