QFI offers assistance to medical device companies affected by LRQA’s cessation of Notified Body services under the Medical Devices Directives

19 June 2019

London-based medical device regulatory consultancy Quality First

London-based medical device regulatory consultancy Quality First International offers medical device manufacturers support on this matter, including transitions to another Notified Body.

The British medical device regulatory consultancy Quality First International advises several client companies affected by the imminent cessation of LRQA’s services as a Notified Body under the current Medical Devices Directives.

QFI has a team in place to help any company requiring support on this matter, including transfers and transitions to another Notified Body for the Medical Devices Directive (93/42/EEC) and the In-Vitro Diagnostic Directive (98/79/EC), facilitating transfer, aligning CE technical documentation expectations to minimise any risk of disruption to business, and agreeing expedition.

Affected medical device companies were informed by LRQA that any current CE certificates will be withdrawn 90 days from the official date of cessation of LRQA’s services.

Medical device manufacturers interested in this service may contact QFI by email enquiries@qualityfirstint.com or telephone +44 (0)208 221 2361.