Journey To Regulatory Compliance For In Vitro Diagnostic (IVD) Medical Device Manufacturers


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

  1. Identify their roles under the relevant regulatory requirements
  2. Identify the regulatory requirements that apply to its activities under these roles.
  3. Apply these regulatory requirements to its QMS.


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:

  1. ISO 13485:2016 demonstrates that certified companies have met the mandatory regulatory obligations. Certification, with a third-party organization such as SGS, is evidence of the manufacturer demonstration they are meeting their regulatory obligations and ensuring due diligence for compliance.
  2. ISO 13485:2016 reduces the potential for legal and safety risks on the part of IVD manufacturers due to an enhanced managed quality system
  3. Having ISO 13485:2016  enhances the credibility of IVD manufacturers with the relevant sector certification to uphold them as trustworthy reputable providers in a highly regulated market.
  4. Companies that have implemented ISO 13485:2016 are considered more attractive prospects by especially larger medical companies.
  5. ISO 13485:2016  helps create a formidable quality management system that forms a solid foundation for product development and quality assurance. This works largely to the advantage of IVD & medical device manufacturers in meeting regulatory compliance expectations.
ISO 13485:2016 certification as preparation in your journey to In Vitro Diagnostic Medical Device Regulations (IVDR) compliance

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)

How SGS can help

The SGS sets clients up for their journey to certification by efficiently facilitating these areas:

  1. Planning: SGS helps in the area of planning by leading internal auditor training and implementing training courses for IVDR. They also provide the necessary training needed by IVDR Responsible Persons.
  2. Documentation and Implementation: SGS also document and implement ISO 13485 certification training courses
  3. Review/Audit: SGS  reviews and audits the ISO 13485 certification training courses of the lead and internal auditor.
  4. Certification Assessment: SGS facilitates ISO 13485 certification Audits
  5. Maintenance: SGS carries out Surveillance and Recertification audits where necessary


Learn more about SGS Medical Device Servies.



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