Module 18 2021

05/02/2021

Historically – Pre Brexit

MHRA (UK) • Combined agency for drugs and devices • Pragmatic approach • Conducted the majority of assessments but now outside the EU System • UKCA System will require consultations with MHRA

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The Organisation for Professionals in Regulatory Affairs

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Conformity Assessment Process

EU Competent Authority

Notified Body

• Consultation documentation submitted with NB usefulness report

• NB conducts a usefulness evaluation an writes report • NB completes Technical Documentation and QMS Assessments in parallel • The notified body will give due consideration to the views expressed in the CA consultation when making its final decision on certification • For negative opinions - CE Certification can not be recommended • NB must convey its final decision to the competent authority

• Document validation stage prior to clock start

• Team assess data provided and provide a report to the NB • The opinion of the competent agency or national authority must be drawn up within 210 days after receipt of a valid documentation • CA report to NB – outcome and any conditions shared with manufacturer by NB

The Organisation for Professionals in Regulatory Affairs

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