Lloyd's Register bevestigt de intrekking van diensten van de Notified Body met betrekking tot de Richtlijn Medische Hulpmiddelen
Gepubliceerd op 16-08-19
Lloyd's Register bevestigt de intrekking van diensten van de Notified Body met betrekking tot de Richtlijn Medische Hulpmiddelen (93/42 / EEG) (MDD) en de Richtlijn In-Vitro Diagnostic Devices (98/79 / EG) (IVDD).
Lloyd's Register bevestigt de intrekking van diensten van de Notified Body met betrekking tot de Richtlijn Medische Hulpmiddelen (93/42 / EEG) (MDD) en de Richtlijn In-Vitro Diagnostic Devices (98/79 / EG) (IVDD).Lloyd’s Register withdraws MDD and IVDD services.
13 Jun 2019
Lloyd’s Register confirms withdrawal of Notified Body services relating to the Medical Devices Directive (93/42/EEC) (MDD) and the In-Vitro Diagnostic Devices Directive (98/79/EC) (IVDD).
Share this news item
Following recent market developments, we have made the strategic business decision to exit from these services. We are also withdrawing our application to become a Netherlands-based EU Notified Body for these services and furthermore, will not be applying to become a Notified Body for Medical Devices Regulation (MDR) or In-Vitro Diagnostic Devices Regulation (IVDR).
We will, however, continue to provide ISO 13485 and Medical Device Single Audit Program (MDSAP) third party certification and medical devices-related training to clients both in the UK and worldwide.
We are working closely with the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to help customers which hold certification for these Directives with Lloyd’s Register transfer to an alternative service provider.
https://www.lr.org/en/latest-news/lloyds-register-withdraws-mdd-and-ivdd-services/