Module 17 2024

05/12/2024

Implementation of UA’s by Notified Bodies

• Implementation of the UA varied in practice; there was not a harmonized approach across the EU. • After enforcement of the EU recommendation by the various Competent Authorities, most NBs started to implement the requirements of the EU 2013/473/EU recommendation, despite some legal challenges by manufacturers • Apart from the process and planning implications surrounding UA’s, the biggest challenge was (and remains to be) capacity constraints; not enough personnel available to carry out the task; • Also, a lot of worries were communicated from industry, especially regarding the planning around UA’s and the consequences of a bad outcome at a UA (e.g., suspension of CE Certification);

The Organisation for Professionals in Regulatory Affairs

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Implementation of UA’s by Notified Bodies

• Who – All devices which have a CE mark except MD Class I (Note: True if devices still using MDD/IVDD certificates) • The whole supply chain should be considered when determining where to perform an unannounced visit: the legal manufacturer, manufacturing locations, critical subcontractors… • Site of Manufacturing • Site of Testing • Critical Supplier – supplier delivering materials, components or services that may influence the safety or performance of the device

The Organisation for Professionals in Regulatory Affairs

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