Module 19 2021

24/05/2021

Annex IX – QMS and Tech Doc

Chapter III: Administrative Provisions ● Each Member State shall make provision that this documentation is kept at the disposal of the competent authorities for the period indicated in the first sentence of the preceding paragraph in case the manufacturer, or his authorised representative, established within its territory goes bankrupt or ceases its business activity prior to the end of this period.

The Organisation for Professionals in Regulatory Affairs

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Annex X – EU-Type

Upon application the manufacturer will provide ● Technical documentation referred to in Annexes II and III and outlined in Annex X ● Representative sample(s) of device The NB will ● Review all documentation and arrange for tests to verify the devcie meets the relevant GSPRs. ● Arrange for tests to verify that applied harmonised standards have been applied. ● Class D devices – involvement of EU reference labs ● Companion Diagnostics – involvement of EMA ● Certification issued for the specific device type examined.

The Organisation for Professionals in Regulatory Affairs

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