June 28, 2023
The beauty of regulatory guidance
When it comes to medical device regulation, legislation is primary. An experienced regulatory professional quickly understands the importance of guidance. While guidance is not legally binding, it often provides consensus interpretation to accompany legislation.
This is particularly true in the US and EU where sometimes, legislation can be quite succinct. In the US, guidance proffered by the Food and Drug Administration (FDA) can include sufficient detail to facilitate a submission of a medical device with a particular product code or technical characteristics. In the EU, guidance from the European Commission (EC) can represent positions established by the large group of EU member state representatives or guidance to support disparate product categories (more on this).
Understanding the Blue Guide and the New Approach in Europe
The New Approach was established with Council Resolution 7 May 1985 on a New Approach to technical harmonization and standards and the Global Approach to conformity assessment (Council Resolution 21 December 1989) (and eventually Council Decision 93/465/EEC on conformity assessment modules). This replaced the former Old Approach. Under the context of this New Approach, a portfolio of corollary legislation was released, often referred to as the New Approach (and the Global Approach) Directives. This group of product legislation takes a modular approach to compliance; adheres to the applicable technical “essential” requirements (identified as applicable by the manufacturer); capitalizes on voluntary European standards, presumed to be compliant if manufactured compliant to the standards; and has the CE marking affixed as a mark of compliance.
There were 22 product Directives, ranging from medical devices and IVDs to toys and electrical products.
New Legislative Framework in 2008
The New Approach was subsequently replaced by New Legislative Framework (NLF) legislation: this package consisted of two Regulations and one Decision. The objective was to improve the internal EU market and enhance the conditions for placing different products on the EU.
The NLF is the current regulatory regime for a large number of products. In addition, with time, the portfolio of legislation added the Restriction of Hazardous Substances (RoHS) in Electric products, fertilizing product and drones (and the Medical Devices Directive and Active Implantable Medical Devices Directive condensed into the Medical Devices Regulation (MDR 2017/745)).
First guide in 1994
The EC published the first guide in 1994, Guide to the implementation of Community harmonization directives based on the new approach and the global approach. It was also referred to as the Vademacum. This is a great historical document, in typewriter font with a blue cover.
More official guidance in 2000
A more complete guide was released in 2000 titled Guide to the implementation of directives based on the New Approach and the Global Approach. This 120 page document provides the structure of the current version of the guidance. Again, there was a blue cover.
Blue Guide Revised 2014, 2016, and 2022
It was not until the 2014 version was published, that the 2000 version was officially referred to as Blue Guide. Though in industry, we were all unofficially referring to the document as the Blue Guide. The 2014 Blue Guide was released to align with the NLF. One Annex introduced was a Frequently Asked Questions on CE Marking.
The Blue Guide was subsequently revised in 2016. The latest revision was released in 2022. This last version presents new development in regard to repairs and modifications to products, software, distance and online sales, and the addition of a section about the withdrawal of the United Kingdom from the EU. The 2022 Blue Guide accounts for the market surveillance regulation (2019/1020).
The Blue Guide 2022 is a veritable tome and a must-read for any regulatory professional interested in the legislation applicable to many products in the EU. It is the consensus guidance for the NLF and products subject to CE marking, and provides the history of the legislation related to products which required the CE marking: Old Approach, New Approach, and NLF.
This also facilitates some of the regulatory understanding related to making available, placing on the market, and distance and online sales.
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