For some years now, the harmonization of standards in the EU has been slow. Manufacturers of medical devices are currently feeling this, especially in the context of the EU Medical Device Regulation (MDR, (EU) 2017/745). In 2021, this replaced Directive 93/42 / EEC on medical devices (Medical Device Directive, MDD) away. However, there are still hardly any standards harmonized for the regulation.


The fact that the EU has struggled with harmonization in recent years is due, among other things, to two judgments by European courts: the “James Elliott judgment” of the Court of Justice of the European Union (ECJ) from 2016 and the “Global Garden judgment” of the European Court of Justice (EGC) from 2017.

This post:

  • introduces you to the two judgments and
  • explains how they affect the harmonization of European standards and what that means for manufacturers.
1. Importance of harmonized EU standards

With the help of standards, manufacturers of medical devices can prove that their products meet the requirements of legal regulations. Norms are standards that represent the state of the art.

Example:

If the MDR requires a quality management system, manufacturers can orientate themselves on ISO 13485.

Harmonized standards have been commissioned by the European Commission itself. They are therefore coordinated with European regulations and recognized by the public authorities.

The EU regulation 1025/2012 (standardization regulation) defines the term harmonized standard as

a European standard adopted on the basis of a mandate from the Commission to implement Union harmonization legislation

Art. 2 Para. 1 c) Standardization Ordinance

If manufacturers rely on harmonized standards, there is a “presumption of conformity” for conformity with the legal provisions with which they are harmonized.

The standards harmonized with a specific EU regulation are published in the Official Journal of the European Union .

Example:

  • The EU published the first standards that are harmonized with the MDR on July 16, 2021.
  • This includes, for example, EN ISO 10993-23: 2021 - Biological assessment of medical devices - Part 23: Tests for irritation (ISO 10993-23: 2021).
2. Slow harmonization and the reasons for it a) Current situation

In recent years, however, the Commission has published harmonized standards less and less frequently. This is felt by manufacturers of medical devices, especially in connection with the new MDR and the EU Regulation 2017/746 on in-vitro diagnostics (IVDR). The MDR has been binding since 2021, the IVDR is to apply from 2022.

As of October 2021, standards relating to the sterilization of products and biocompatibility are almost exclusively harmonized for both ordinances.

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