After approximately six years after the previous (2016) version of the Blue Guide the 2022 version finally ‘dropped’ on 29 June 2022 in the Official Journal edition C edition of that day.
I will discuss new and amended headings and subjects in the Blue Guide 2022 compared to the 2016 version in a series of blogs that are to follow this one, which serves to give you a general initial overview.
Spoiler: in short the Blue Guide 2022 does not provide a lot of new things for devices in scope of the MDR or IVDR, but it does make some things more confusing. For example, it does not remedy the inconsistencies due to language differences with respect to the concept of placing on the market, which I myself consider a major missed opportunity. It shows also that you can never rely on just one language version of an EU document, and if you don’t understand more than one language (which would usually be English) you are prone limit your options of interpretation.
And the new Blue Guide also contains quite a lot of smaller changes, many of which were sort of figured out in practice by now, such as dealing with fulfillment services providers, software, etc. and details on the Market Surveillance Regulation that was adopted after the 2016 version of the Blue Guide. Although the Market Surveillance Regulation looks to change a lot regarding economic operators in general, some of the most impactful changes do not apply to medical devices and IVDs – a good reminder not to forget that the Blue Guide is a ‘one size describes all in not so much detail’, and does not necessarily state the exemptions to every rule if there happens to be one. Although I always urge clients to read the Blue Guide, I also urge them to not only read the Blue Guide but also the legislation that is actually mandatory because Blue Guide is just guidance, not law. Many people in regulatory affairs have difficulty understanding this difference and routinely refer to the Blue Guide as that it ‘requires’ or ‘obliges’, which is simply not the case. Guidance is guidance, and not mandatory law. This is also reiterated in the Blue Guide itself.
However, the Commission calls it a:
“substantial update and takes into account developments that have come up since 2016, for example related to the Market Surveillance Regulation [MSR] (EU) 2019/1020. It also elaborates on specific features such as distance sales, making products available on the market subject to physical modifications or software updates and the assessment of conformity assessment bodies.”Commission website
While this may be true for other New Legislative Framework (NLF) legislation covered products, the MDR and IVDR contain a number provisions that already deal with some of these developments (e.g. distance sales, parts and components, software) or constitute a lex specialis to which some of the new MSR requirements simply do not apply (see below in the table). Did I already say not to look only at the Blue Guide?
To provide a bit more context for the people that would like to have more detail on what is new and where to look for it, see below for a summary table analysis:
|Reference||New item, significantly amended item or problematic item||Comments|
|Chapter 2: when does EU law on products apply?|
|Section 2.1 Product coverage||New||New headings for Repairs and modifications to products and Software, but these contain nothing new for medical devices or IVDs. Makes analogy between software changes and maintenance/repair of physical devices. Interpretation of when a part / component is a separate product – lex specialis on components and parts in article 23 MDR and 20 IVDR.|
|Section 2.3 Placing on the market||Problematic||Incoherence between language versions as regards the exact criterion for placing on the market (‘transfer of ANY other right’ or ‘transfer of PROPERTY right’?). New elements in the Blue Guide such as new sections 2.4 and 2.12 increase the confusion as these refer to placing on the markets in situations where no property right is transferred, unhelpfully contradicting what is stated in section 2.3.|
|Section 2.4 Making available and placing on the market in case of distance and online sales||New||Explains that products offered for sale online or through other means of distance sales are deemed to be made available on the Union market if the offer is targeted at end users in the Union. This principle is already accounted for in article 6 MDR and IVDR.|
|Section 2.9.5 Brexit||Newish||Consistent with Commission Brexit guidance on economic operator consequences.|
|Section 2.9.6||New||Explanation of how the Northern Ireland Protocol affects NLF regulation: all Union harmonisation legislation covered by the Blue Guide applies to and in the United Kingdom in respect of Northern Ireland. As a result, insofar as EU law made applicable by the IE/NI Protocol to the United Kingdom in respect of Northern Ireland is concerned, references to the EU have to be understood as including Northern Ireland, whereas references to the United Kingdom have to be understood as referring only to Great Britain. This is yet another good reason to refer to the Union when referring to the geographic scope of the MDR / IVDR and not to the EU as scope, which does not include a number of countries in which the MDR and IVDR do apply.|
|Section 2.12 Summary examples||New||Examples to demonstrate a number of issues regarding temporal and geographic scope of application of NLF legislation. Good to review because they address widely misunderstood matters (such as the misunderstanding that the geographic scope of the MDR or IVDR is the EU). The first example also demonstrates that transfer of a property right is not needed for placing on the market (see above under 2.3). Also, the examples show ways to structure distribution for strategic placing on the market in view of expiring legacy devices certificates (such as creating an ‘internal’ distributor subsidiary to function as MDR/IVDR importer or distributor) to better manage the MDR danger zone [https://medicaldeviceslegal.com/2022/06/20/managing-the-2024-mdr-danger-zone-and-outlines-of-a-potential-solution-in-mdcg-2022-11/].|
|Chapter 3: actors and obligations|
|Section 3.5 Fulfillment services providers||Newish||Already addressed in less detail in Blue Guide 2016 in relation to distributors of medical devices, alignment with the MSR definition of fulfillment services provider. Note that the ‘economic operator in the meaning of article 4 MSR’ requirements discussed in this section do not apply in the field of medical devices and IVDs, see article 4 (1) and (5) MSR.|
|Section 3.6 The economic operator referred to in Article 4 of Regulation (EU) 2019/1020||New||While this is new (although not that much because already applies since date of application of the MSR) note that the requirements for ‘economic operator in the meaning of article 4 MSR’ do not apply in the field of medical devices and IVDs, see article 4 (1) and (5) MSR which do not list the MDR and IVDR among the product legislation to which product scope these requirements apply.|
|Chapter 7: Market surveillance|
|Section 7.6.6. Medical devices: vigilance system||Newish||Summary of medical devices vigilance compared to general product market surveillance under NLF regulations and updated from Section 7.5.6 Blue Guide 2016 for MDR/IVDR references. More generally Chapter 7 was updated to account for the changes implemented by the MSR.|
|Chapter 9: International Aspects of the EU Law on Products|
|Section 9.2.2 Switzerland||Amended||Amended but outdated already, because the text states that the MRA covers medical devices ‘partially’, an obvious reference to the MRA for the IVDD not having expired yet. As of the date of application of the IVDR on 26 May 2022 IVDs are not covered by a MRA with Switzerland anymore.|
|Section 9.3 Brexit||Newish||Description of the post-Brexit arrangement with the UK (‘Trade and Cooperation Agreement’), consistent with earlier Commission guidance. Somewhat overly optimistic description of the actual legal situation.|
As you can see, while a lot has changed in the last six years since the 2016 version of the Blue Guide, people that have kept track of developments over the last years will find that the new version does not contain a lot of new things that are actually surprising but rather comprise a description of recent developments. The notable surprising exception is that the Commission neglected to fix the incoherency between language versions with respect to the concept of placing on the market, only one of the most important defined concepts in NLF legislation even though the Commission has been made aware of this. This will just serve to create confusion but also limit the legal options of companies because the restrictive interpretation (transfer of any (other) property right) has in the mean time propagated to MDCG guidance (MDCG 2021-27). It is a pity that the MDCG just copied that the English text for that guidance just because it was in the English language version of the Blue Guide 2016. If the MDCG (and the Commission presiding it) had only looked at the French and German version too – which are also Commission working languages by the way – they would have understood that they were making a totally avoidable mistake here.
Reader beware: this blog post provides just a very rough initial overview! I have not yet done a letter-by-letter comparison of the 2016 and 2022 versions because I’m on holiday at the moment, but will do so at some point. Additional details resulting from this comparison will be addressed in the detailed follow-up articles. Who knows, there may still be some interesting Easter eggs hidden in the new Blue Guide.
Next up: the first of the series, a detailed article about the changes to Chapter 2 – when does EU law on products apply? Watch this space, which is always a good idea anyhow.