MDCG 2021-5 Guidance: Standardization for Medical Devices

As of July 2nd, 2024, MDCG 2021-5 Rev.1 – Guidance on Standardization for Medical Devices, has been updated.

Overall, the MDCG 2021-5 Rev.1 Guidance on Standardization for Medical Devices, focuses on aiding stakeholders in the medical device industry to understand and implement Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). This guidance mainly highlights the involvement and functionality of standards in demonstrating compliance and conformity with the aforementioned Regulations.

In summary, the key takeaways of the MDCG 2021-5 Rev.1 guidance include, but are not limited to:

EU Legislation – “New Approach” and the “New Legislative Framework” – and the role of harmonized standards:

• • Overall, the new Regulations, MDR and IVDR, require the involvement of harmonized standards. In fact, these standards play a crucial role in understanding concepts such as product characteristics and technical details. This is merely because the EU legislation is limited at establishing such details, and thus, the harmonized standards provide the required additional guidance to support the legislative requirements. Henceforth, the guidance emphasizes the importance of using harmonized standards to further demonstrate compliance to the applicable EU legislation.

The General Framework, Use and Development of Harmonized European Standards to support EU legislations:

• • Applying harmonized standards play a pivotal role in demonstrating conformity and compliance with the aforementioned Regulations. However, the guidance recognizes that not all standards are compulsory. In fact, it states that the use of standards in the medical device industry remains voluntary. Consequently, this means that the Manufacturer shall decide, as applicable, whether or not to use a standard. Nevertheless, it additionally encourages the use of harmonized standards for other stakeholders beyond the Manufacturer, for example, Notified Bodies when checking for compliance.
  • Furthermore, the guidance focuses on the relationship between harmonized standards, the EU legislations, and the use of non-harmonized standards. Where harmonized standards are not available, the guidance identifies how to use other international and/or national standards, guidelines, or specifications to demonstrate compliance, including recommendations on assessing the relevance and adequacy of these alternative standards.
  • Additionally, it focuses on the process of how such harmonized standards are developed by the European Standardization Organizations (ESOs), the role of the various stakeholders in the development, and lastly how they are published in the Official Journal of the European Union (OJEU).

The concept of “State of the Art” and its impact on the harmonized standards:

• • The Regulations reference the need of Manufacturers to “take into account the generally acknowledge state of the art” such that they can comply with the health, safety, and performance requirements. The guidance clearly emphasizes the difference between “taking into account” versus “compliance”; this is because it recognizes that the concept of “state of the art” is not legally defined due to its complexities involving several dynamic aspects. Thus, such complexity makes it hard to define the term in a singular and clear definition.
  • Consequently, the guidance provides various non-legally binding definitions of the term that are useful to consider in practice. Overall, the guidance states that it is commonly considered that the most recent versions of standards, providing technical solutions, reflect the “state of the art”. However, it clarifies that the “state of the art” identified within the standards shall be taken into account, but it does not directly grant compliance to the legislative requirements. Henceforth, it is upon the stakeholders, including Manufacturers and Notified Bodies, to check that compliance to the legislations is met via taking into consideration the standards, guidance and best practices.
  • Ultimately, the guidance nicely states that ‘choosing to use a standard or not, as appropriate and applicable, belongs to the manufacturer, within its overall and ultimate responsibility on the legal compliance of products intended to be placed on the EU market’.

The EU Court of Justice (ECJ) Rulings and their Practical Implementation:

• • The guidance provides various cases related to specific aspects of the EU standards, including cases that have impacted the medical device industry. Therefore, via such case law, the guidance illustrates how standards impact the various stages of a medical device.

Considering the above, we advise Manufacturers to read the updated MDCG 2021-5 Rev.1 to further understand the impact and importance of harmonized standards.

For more information, you may read and download MDCG 2021-5 Rev.1 here.

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