Staying compliant with ISO 13485:2016 ahead of new EU IVD Regulations scheduled for implementation in 2022 is the first step in achieving regulatory compliance for IVD medical device manufacturers. This article beams focus on the journey to ISO 13485 certification journey and SGS’s capabilities in actualizing this first step in the compliance journey of IVD medical device manufacturers.
Global standards are integral to fueling continuous innovation that drives medical device technology. Hence, the ISO 13485 certification came into existence as a standard from the International Organization for Standardization designed to regulate QMS (quality management systems) of companies producing medical devices. ISO 13485 certification helps medical device companies QMS (Quality Management System) ensure they meet the requirements for regulatory purposes and demonstrates these companies’ capacity to consistently meet customer needs.
The impending changes regarding the regulatory framework that allows for market access mean that corresponding changes to the EU (the EU IVD Regulation) compliance requirements are bound to occur. As things stand, the EU Directive mandates a notified body certification of only about 20% of the higher risk IVD devices. But in the new regime, this rule will apply to an estimated 80% of all IVD devices.
Reaching these lofty standards may prove difficult, hence the need to start with ISO 13485:2016 certification.
ISO 13485:2016 extends to manufacturers of IVD’s and medical devices, suppliers, or any other external parties integral to the production process. It covers all the companies operating at any level in the IVD & medical device supply chain.
With a purpose to facilitate harmonized medical device regulatory requirement across different regulatory regions, the ISO 13485:2016 standard mandates organizations to consider jurisdictions whose regulations require a QMS (Quality Management System) and
Concerning IVD/Medical Device Companies, the ISO 13485:2016 standard operates to regulate the risk management approach to product realization and development, validation of processes, efficient product traceability and recall system, statutory and regulatory compliance, process and product improvement.
The commitment that the ISO 13485:2016 certification presumes on the part of companies to manufacture regulatory compliant medical devices is the pick of the bunch of its benefits. Furthermore, we shall proceed to enumerate the benefits of implementing ISO 13485:2016 in its own rights:
The soon-to-be-rolled-out IVD Regulations (IVDR) upgrades the prerequisites for compliance while even adding further obligations. For instance, the “No Grandfathering” requirement mandates all currently IVDD certified devices to be recertified to the new IVD Regulations. The necessary implication of this is that any prior compliance with the IVDD will not be recognized automatically. This may spell harsh consequences for IVD devices that are ‘self-declared.
While these changes in the EU regulatory framework might be intensive, scaling these hurdles begins with the first ‘baby steps’ of securing ISO 13485:2016 certification to put manufacturers on a solid footing for their regulatory compliance journey. (preparing for the new IVD Regulations)
The SGS sets clients up for their journey to certification by efficiently facilitating these areas:
Learn more about SGS Medical Device Servies.