Jump to navigation
Creating compliant packaging for a cosmetic product is a collaborative effort of various departments in an organization such as: Labeling, Artwork and Regulatory Affairs. While label artwork must be validated by an artwork labeling team, it must combinedly be reviewed and approved by Regulatory Affairs team to ensure the compliance.
Artwork services for the current Consumer Healthcare/Food Supplements landscapes are divided as per the markets. For Compliance based markets, artworks are created by Freyr team and submitted to the client for finalizing the artwork/ label.
The current medical device landscape has turned challenging for manufacturers in terms of ensuring quality and audit compliance due to ever-evolving regulations which may lead to extended time for approvals and market access.
Class A IVDs under European Union In Vitro Diagnostic Devices Regulations (EU IVDR) 2017/745 require self-certification. The manufacturer is required to self-declare their product’s compliance with the EU IVDR’s requirements and affix the CE marking.
The medical devices and In Vitro Diagnostic devices (IVDs) under the European Union Medical Device Regulation (EU MDR) 2017/745 and In Vitro Diagnostic Devices Regulations (IVDR) 2017/746 are categorized into four (04) classes and twenty-two (22) rules (MDR)/ seven (07) rules (IVDR). Compared to the previous scope of the product in the Directives, the current regulation has expanded its scope...
Companion Diagnostics (CDx) are In Vitro Diagnostic devices used in conjunction with therapeutic drugs to determine their suitability for the patients. To place the CDx in the European Union, the manufacturer is required to submit technical and other relevant documents to the Notified Body (NB) for technical and conformity assessment.
Implementing and maintaining a Quality Management System (QMS) is mandatory to launch medical devices in the global markets. Having an effective QMS should embody all the procedures and processes covering all aspects from design to production, packaging and distribution.
It is a known fact that the European Union’s In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) will be in effect from May 26, 2022 and IVD manufacturers have to be prepared to implement the mandatory Regulatory requirements for this transition.
North Africa & Middle East
Australia & New Zealand
Japan & South Korea
Get Blog Updates Delivered Straight to Your Inbox