Team Notified Body Issue Call to Action for Manufacturers of Class D In-Vitro Diagnostic Medical Devices
In order to address the slow transition and prevent shortages of IVDs on the market, the amending regulation (EU) 2022/112 of 25 January 2022 introduced a stepped extension of transition periods based on the classification of the IVD. While the amending regulation has provided additional transitional time, the first deadline of 26 May 2025 for ...
MDCG 2022-8: Application of IVDR to Legacy Devices
As most IVD manufacturers will know, a derogation to the IVDR was passed earlier this year which allows for a stepped transition in accordance with Article 110(3) of the IVDR. This allows for General IVDs registered under the IVD Directive which will require Notified Body intervention under the Regulation an extended transition period. However, there ...
Key Own-Branding Guidance for OBL Manufacturers
OBL Guidance to Clients This article is now obsolete and has been replaced by our article on Virtual Manufacturing, which has replaced OBL. Press here to be redirected. As you are probably aware there have been significant changes to the requirements of Own Brand Labelling [OBL] in relation to the MDD 93/42/EEC and IVDD 98/79/EC contained ...
Notified Body Unannounced Audits
SGS Notified Body presented a very interesting Webinar on November 13th (some of you may have been joining in) and this presentation was repeated again during the MEDICA show in Düsseldorf. The story remains unchanged with Notified Bodies making it very clear that from January 2014 the audit processes will be changing for all manufacturers ...
