The Role of harmonised standards in the IVDR Framework

As the European Union transitioned from the In Vitro Diagnostic Devices Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR), many aspects of IVDR (Regulation (EU) 2017/746) have changed, not least the role and importance of harmonised standards. These are European standards that provide practical solutions for complying with the legal requirements of IVDR. This blog post will delve into the function of harmonized standards under the IVDR and explain their implications for IVD device manufacturers.

What are Harmonised Standards?
Harmonised standards are technical standards developed by recognized European Standardization Organizations (ESOs), such as the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC). They’re designed to provide means of compliance with the legal requirements outlined in EU legislation, in this case, the IVDR.

When a standard is ‘harmonized,’ it means that it has been acknowledged by the European Commission (EC) and published in the Official Journal of the European Union (OJEU). These standards provide a presumption of conformity with the corresponding requirements of the harmonisation legislation.

The Importance of Harmonised Standards in IVDR
Under the IVDR, the role of harmonized standards has become more important than ever. While they are not mandatory, using harmonized standards can significantly streamline the regulatory process for IVD device manufacturers. By applying these standards, manufacturers can ensure their products meet the IVDR’s general safety and performance requirements (GSPR).

In the IVDR context, harmonized standards can apply to various aspects of an IVD product, including design and manufacturing, performance evaluation, technical documentation, post-market surveillance, and more. Using these standards can also provide legal security, as it offers a presumption of conformity with the regulation.

Applying Harmonised Standards
The process of applying harmonized standards begins with identifying the relevant standards for a particular IVD device. The standard’s reference number, title, and link to the text are published in the OJEU. Once identified, manufacturers can incorporate these standards into their product development process.

It’s important to note that simply using a harmonized standard doesn’t automatically ensure compliance. Manufacturers should understand the standard’s content, apply it correctly, and generate evidence to demonstrate their product’s conformity with the relevant requirements of IVDR.

The Current Situation
Many harmonized standards for the IVDR had yet to be published. It’s essential for manufacturers to stay updated on the latest developments, as the list of harmonized standards can evolve over time.

Harmonized standards are powerful tools in the hands of IVD device manufacturers, offering a presumption of conformity with the essential requirements of the IVDR. By staying up-to-date with the latest harmonized standards and effectively incorporating them into their product development and quality management processes, manufacturers can greatly facilitate their path to compliance and market entry. As the regulatory landscape continues to evolve, understanding and leveraging these standards will undoubtedly remain crucial for success in the European IVD market.

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