Updated guidance on implementation of EU product rules

European Commission publishes 2022 revision of its ‘Blue Guide’

For those with long memories, the ’Blue Guide’ represents the descriptor for the UK Department of Health ‘Guide to Good Manufacturing Practice (GMP) for sterile medical devices’. This was first published in 1979 and updated in 1981 and 1990. This ‘Blue Guide’ was one of a series of rainbow-coloured GMP documents for specific types of medical devices that were replaced first by the BS EN 46000 series of standards and supporting guidance documents, where EN 46001 was Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001, and ultimately EN ISO 13485 - Medical devices — Quality management systems — Requirements for regulatory purposes.

In 2000, the EU Commission published its guide to the implementation of Directives based on the New Approach and the Global Approach and named it the ‘Blue Guide’. This Blue Guide is one of the main reference documents explaining how to implement legislation based on what was the New Approach, that is now called the New Legislative Framework. The Blue Guide was revised in 2014 and 2016. The 2022 edition of the Blue Guide reflects recent changes in legislation and the adoption of the new Regulation on Market Surveillance ((EU) 2019/1020). The Blue Guide is purely intended as a guidance document. Only the text of the particular EU legislation that the Blue Guide summarises has legal force. It is important to be aware that the Blue Guide describes the underlying principles behind the legislation but that there can be some differences between particular EU legislation. The content of the Blue Guide as slight divergence between different legislation cannot be fully described. The Guide applies to the EU Member States but also to Iceland, Liechtenstein and Norway as signatories of the Agreement on the European Economic Area (EEA), as well as Switzerland and Turkey in certain cases. It is also relevant to Northern Ireland due to the protocol which extends the application of certain EU product rules to Northern Ireland.

The Guide describes the progressive development of EU legislation for non-food and non-agricultural products, referred to as industrial products, whether for use by consumers or professionals that are covered by 70 regulations and directives. Included are the regulations for medical devices and in vitro diagnostic medical devices (IVDs). The elements of the legislation cover:

• Essential or other legal requirements,
• Product standards
• Standards and rules for the competence of conformity assessment bodies and accreditation,
• Standards for quality management,
• Conformity assessment procedures,
• CE marking,
• Accreditation policy,
• Market surveillance policy, and
• Control of products from third countries.

In regards to medical devices and IVDs, many of the changes that have been incorporated into the Regulations as part of the transition from the Directives are directly influenced by this evolution of the legislative framework. For example, the increased focus on the product lifecycle, supply chain and market surveillance, competence requirements for notified bodies, requirements on distance sales and emphasis on software. 

While the Blue Guide 2022 does not necessarily introduce new elements for medical devices or IVDs, it provides a great deal of background and examples that can clarify the reasons for which certain provisions were included in the EU devices regulations. It can also assist in interpreting the generic requirements. Keep in mind, however, that it is a guide and that the legislation always takes precedence.