What Are Harmonised Standards?

Harmonised standards are technical specifications developed by European standardisation bodies (CEN and CENELEC) at the request of the European Commission. Their purpose is to enable manufacturers of medical devices and in vitro diagnostic (IVD) devices to demonstrate compliance with the essential requirements set out in the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). Applying these standards provides a presumption of conformity with EU law and represents the most efficient route to certification.

Is the Use of Harmonised Standards Mandatory?

Formally, no. A manufacturer can demonstrate product compliance without using harmonised standards. However, they must then provide validated alternative solutions and detailed justification of their equivalence. Any deviation must be clearly explained in the technical documentation and may increase the risk of rejection by the notified body.

The Role of Harmonised Standards in Market Access

Standards help manufacturers implement MDR and IVDR-compliant processes, reduce procedural errors, and accelerate the attainment of CE marking. They also facilitate the acceptance of technical documentation by notified bodies and shorten certification timelines. Applying current standards ensures alignment with state-of-the-art technical knowledge and regulatory expectations.

Types of Harmonised Standards

Harmonised standards are divided into:

  • Horizontal (general) standards – applicable to all device types, e.g.:
    • EN ISO 13485 – Quality management systems
    • EN ISO 14971 – Risk management
    • EN ISO 15223-1 – Symbols for labelling
    • EN ISO 20417 – Information for users
  • Vertical (specific) standards – for specific devices, technologies or processes, e.g.:
    • EN 60601-1 – Active medical devices
    • EN 62304 – Software as a Medical Device (SaMD)
    • EN ISO 10993 – Biocompatibility testing
    • EN ISO 11135, ISO 11607 – Sterilisation methods and packaging

Importance of Standards in Conformity Assessment

In the context of conformity assessment, harmonised standards enable:

  • Simplified demonstration of MDR/IVDR compliance
  • Reduction in the number of additional tests
  • Improved predictability of notified body reviews
  • Smoother technical documentation audits

Standards for Special Devices and Manufacturing Processes

The selection of standards should consider the type and use of the device:

  • Implants and long-term use devices: EN ISO 10993-1, ISO 14937
  • Energy-emitting devices: EN 60601-1, EN 60601-1-2
  • Software-based devices: EN 62304, ISO 82304-1
  • Sterile packaged devices: ISO 11135 (ETO), ISO 11137 (radiation), ISO 11607 (packaging)

Standards in Biological and Physicochemical Testing

In the context of preclinical testing, standards such as EN ISO 10993-5, 10993-10 and 10993-23 are essential for evaluating cytotoxicity, irritation, and sensitisation. They standardise data and facilitate interpretation by notified bodies.

Changes in Approach – From MDD/IVDD to MDR/IVDR

Compared to MDD and IVDD, MDR and IVDR introduced significant updates:

  • Greater emphasis on risk management, PMS and PMPF
  • Mandatory justification for selected standards in technical documentation
  • Audit-based verification of standard versions in use
  • Continuous monitoring and implementation of standard updates

Where to Find the Latest List of Harmonised Standards?

The official list is published in the Official Journal of the European Union. Additional resources include the websites of CEN, CENELEC, ISO, IEC and national standardisation bodies. Manufacturers should implement a review procedure as part of their ISO 13485 quality system to stay updated.

What to Do If No Harmonised Standard Exists?

When no harmonised standard is available for a product or process:

  • International standards (ISO, ASTM) may be used
  • Internal technical specifications can be developed, if validated
  • Early consultation with a notified body is highly recommended

All alternative approaches must be well documented and justified in the technical file.

How Pure Clinical Supports the Use of Harmonised Standards

Pure Clinical provides full support for identifying and implementing harmonised standards for medical devices and IVDs. Our services include:

  • Auditing existing documentation for MDR/IVDR compliance
  • Recommending relevant horizontal and vertical standards
  • Supporting justification of alternative solutions when no harmonised standards are available
  • Preparing manufacturers for notified body audits based on current harmonised standards

Our team continuously monitors updates from the Official Journal of the EU and CEN/CENELEC, ensuring that all regulatory expectations are met.

FAQ

What is the difference between a harmonised standard and an international standard?

A harmonised standard is officially listed in the Official Journal of the EU and provides a presumption of conformity with MDR or IVDR. International standards (such as ISO or IEC) are not automatically harmonised—if applied, they must be justified and documented as equivalent in the technical file.

How often are harmonised standards updated?

There is no fixed schedule. The European Commission updates the list of harmonised standards several times a year. Manufacturers are required to monitor these changes and update their documentation accordingly.

What are the consequences of using outdated standards?

Using withdrawn or outdated standards may lead to rejection of the technical documentation by the notified body or require additional validation. The manufacturer must demonstrate alignment with the current state of the art.

Can a notified body require the use of a specific standard?

Yes. A notified body may require the application of a specific standard if it deems it necessary to demonstrate compliance with MDR or IVDR. This may apply especially in high-risk devices or where the equivalence of alternative methods is unclear.

Is every ISO standard automatically harmonised with MDR/IVDR?

No. Only specific versions of ISO standards that have been endorsed by the European Commission and published in the Official Journal of the EU are considered harmonised. Others must undergo a separate assessment and justification to demonstrate equivalence.

How can I verify which standards are currently harmonised under MDR or IVDR?

The official list of harmonised standards is published in the Official Journal of the European Union. Additional resources include the websites of CEN, CENELEC, and the European Commission, which regularly update references to newly harmonised documents.