Guidance on Borderline Products
The Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) provide comprehensive and detailed definitions that clearly outline what qualifies as a Medical Device and an In Vitro Diagnostic Medical Device. These definitions are essential, as they serve as the foundation for determining the regulatory pathway for products within the European Union. The ...
Flowchart Issued Relating to the Applicability of the Extension in Transitional Periods as Detailed in (EU) 2023/607.
As many manufacturers currently know, there are many conditions that you must satisfy in order to be eligible for the extension in transitional periods. Although these conditions are stated on the EU 2023/607 document, reading through these conditions, and subsequently determining the applicability could get confusing, and at times hard to follow. In light of ...
Advena Guidance on Regulation (EU) 2023/607
This amendment was introduced to address the projected shortage of medical devices on the market in the coming years and to address the limited capacity of the notified bodies. Since its introduction in March, there have been some notable updates that manufacturers should be made aware of. Advena has created a guidance document that will help ...
Medical Device Reclassifications or Up-Classifications: Devices that Currently do not Require a CE certificate
There are several devices that currently do not require a CE certificate under the Directives, which will need certification under the EU MDR by 26 May 2020 for continued market access. This may be due to up-classifications (e.g. some software that is currently Class I under MDD but are Class IIa or higher under MDR) ...
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OBL Guidance to Clients This article is now obsolete and has been replaced by our article on Virtual Manufacturing, which has replaced OBL.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 ...
MDD RECAST
The Notified Bodies around the world are preparing themselves for the new upcoming MDD regulations recast. The regulation was published on 26th September 2012 includes the new EU regulations on all medical devices. The final regulation is likely to be released in 2014. The changes would reflect: v The new EU regulation structure and system ...
