As announced in my previous blog post providing a general overview of my impression of the changes made in the Blue Guide 2022 compared to the previous 2016 version, this blog post follows up in detail on the changes in Chapter 2. Chapter 2 of the Blue Guide explains when EU law on products applies, both ratione materiae and geographically.
Chapter 2 is one of the most important chapters of the Blue Guide, as it explains among others the crucial concepts of making available, placing on the market, putting into service. Getting the interpretation of these concepts wrong can cause costly mistakes as I will explain below. Unfortunately I see many companies get this wrong in practice or think about them in a too rigid and formalistic way, depriving themselves of regulatory options or getting themselves in trouble.
When reading the Blue Guide 2022 (just repeating it again because I’m often faced with regulatory experts, notified bodies and others referring to the Blue Guide like it’s law – which it is not) you should keep in mind that it is one size fits all language for all New Legislative Framework (NLF) categories of products. This means that there may be more specific or diverging rules for specific products such as medical devices and IVDs, which apply instead of the Blue Guide guidance and may sometimes run counter to it. So never (ever) just rely on the Blue Guide alone, only do that when the applicable product legislation and product legislation guidance do not provide an answer and you need guidance to arbitrate between possible interpretations. Because that is what guidance is for.
And now for the new or newish things in Chapter 2!
Used and second hand products
For used and second hand products the Blue Guide contains a new paragraph in section 2.1 in relation to the General Product Safety Directive (GSPD) (applicable to consumer products) stating that used and second hand products sold to consumers must comply with GSPD requirements.
This is relevant because second hand sales of devices are out of scope of the MDR and IVDR (see recital 3 IVDR and MDR). Economic operators that make used devices available to consumers will need to take this into account, so they’ll need to implement traceability for example.
Spare parts, components and finished products
Spare parts and components are treated differently under NLF legislation than finished products. For that reason it’s very useful to be able to distinguish them well, and we can do that better now with the 2022 Blue Guide. There is a new heading for spare parts, components and finished products in section 2.1:
“If there are two or more finished products made available in the same package which do not constitute a single finished product but which are intended to function together, the manufacturer marketing the combination must address the risks of the products included in the package when used in operation with each other.”Bllue Guide, section 2.1
While this is covered by the lex specialis in article 22 MDR for systems and procedure packs, there is no equivalent rule under the IVDR, don’t ask me why. I think this is actually a (major) regulatory oversight because it’s of course perfectly possible to have IVD systems under the IVDR (although systems including normal medical devices brings the combination in scope of article 22 MDR, which many IVD manufacturers and distributors don’t realise). While the IVDR (like the MDR) contains GSPRs on compatible and interoperable products, these are addressed to the manufacturer of the device for the purpose of CE marking individual devcies, and the manufacturer of an IVD is not necessarily the party placing the combined products on the market as a single combined offering. This means that we are dealing with a genuinely new requirement for IVDs, although this is set out in guidance and therefore not necessarily mandatory.
The Blue Guide 2022 also helpfully confirms that there is not a universal duty to provide spare parts for a specific time after placing on the market (an often asked question), but that this duty does exist in relation to certain consumer products like dishwashers (but not devices), see footnote 39.
Also, keep in mind that the MDR and IVDR have a lex specialis spare parts requirements provision in article 23 MDR and 20 IVDR, discussed extensively in my book The Enriched MDR and IVDR (2nd edition imminent).
Repairs and modifications to products
There is a new heading for repairs and modifications in section 2.1 that contains some new language and incorporates other language on this subject that was already in the 2016 version. This is a relevant paragraph for commercial parties that offer life extension processes for devices already placed on the market, often seen with MDD and IVDD legacy devices that are capital equipment.
The existing principle that the manufacturer is responsible for the device as placed on the market is reiterated in the Blue Guide 2022, but for the device as later modified by the end user or third parties the situation is clarified as follows (not new as a legal rule, but more clearly explained in guidance now):
“Where a modified product is considered as a new product [as a result of the modification, red.], it must comply with the provisions of the applicable legislation when it is made available or put into service. This has to be verified by applying the appropriate conformity assessment procedure laid down by the legislation in question. In particular, if the risk assessment leads to the conclusion that the modified product has to be considered as a new product, then the compliance of the modified product with the applicable essential requirements has to be reassessed and the person carrying out the substantial modification has to fulfil the same requirements as an original manufacturer, for example preparation of the technical documentation, drawing up a EU declaration of conformity and affixing the CE marking on the product. […] The person who carries out important changes to the product carries the responsibility for verifying whether or not it should be considered as a new product in relation to the relevant Union harmonisation legislation. If the product is to be considered as new, this person becomes the manufacturer with the corresponding obligations. Furthermore, in the case the conclusion is that it is a new product, the product has to undergo a full conformity assessment before it is made available on the market and the new manufacture’s name and contact address must be indicated on the product. […] The natural or legal person who carries out changes or has changes carried out to the product shall be responsible for the conformity of the modified product and draw a declaration of conformity, even if they use existing tests and technical documentation.”Blue Guide 2022, section 2.1
When is a product a ‘new’ product?
“A product, which has been subject to important changes or overhaul after it has been put into service must be considered as a new product if: i) its original performance, purpose or type is modified, without this being foreseen in the initial risk assessment; ii) the nature of the hazard has changed or the level of risk has increased in relation to the relevant Union harmonisation legislation; and iii) the product is made available (or put into service if the applicable legislation also covers putting into service within its scope).”Blue Guide 2022, section 2.1
This specification is relevant for the situations where hospitals and third party repair services sometimes considerably modify and overhauil devices without taking responsibity for these modifications. The MDR and IVDR have a lex specialis for this with the defined concept of ‘full refurbishment’, which triggers a new device for which a (new) manufacturer needs to take responsibility and needs to complete conformity assessment to be able to place it on the market and put it into service. The Blue Guide therefore points to the concept of ‘full refurbishment’ that is only seen in the MDR and IVDR (and is a defined term). Where repair leads to full refurbishment, the resulting product is considered placed on the market again, requiring a new manufacturer, importer (if applicable), new conformity assessment, etc.
The Blue Guide reiterates that having your cake (modification) and eat it too (but not taking responsibility for the modification) will not do. This responsiblity does not only apply to devices that are ‘new’ as a result of the modifications: the Blue guide also helpfully specifies that the end user or third party needs to take responsiblity for ANY change carried out to the product (unless this is done by the manufacturer or his service organisation):
“The natural or legal person who carries out changes or has changes carried out to the product shall be responsible for the conformity of the modified product and draw a declaration of conformity, even if they use existing tests and technical documentation.”Blue Guide 2022, section 2.1
This is an important point because in my experience both end users (often hospitals) and third party repair and maintenance services providers do exactly the opposite and third party services providers will often disclaim any such responsibility in their terms and conditions, which can cause problems for the end user / hospital when the device fails or underperforms and causes damage that way. The end user remains responsible for deploying a device within CE marked specifications. This may not be the case anymore after modification by a third party that will not take responsibility for the modification’s impact on the CE marking. Hospitals would do well to double-check the terms and conditons of third party service providers on this point as well as to check their own internal processes for repair, modification and maintenance. In practice I often find these lacking.
There is a new sentence in the Blue Guide that repair and maintenance options must be designed into the product in light of intended purpose (and I assume life time of the product). This is already accounted for in the MDR and IVDR in various places in the GSPRs.
This section is also relevant for software (see below).
There is a new heading for software in section 2.1 but the content is not very new. It discusses prinicples of risk assessment for software in general and points to the MDR and IVDR specifically as being a lex specialis on this point, which they are because the MDR and IVDR have detailed provisions and guidance on the conformity assessment of software as a medical device (which includes of course risk management) and for provision of devices as a software service.
The interesting part in the clarification is the explicit linking of software updates and maintainance to hardware concepts of repair, (full) refurbishment and maintenance, although this is also not necessarily new for devices in my opinion:
“Software updates or repairs could be assimilated to maintenance operations provided that they do not modify a product already placed on the market in such a way that compliance with the applicable requirements may be affected. As is the case for physical repairs or modifications, a product should be considered as substantially modified by a software change where: i) the software update modifies the original intended functions, type or performance of the product and this was not foreseen in the initial risk assessment; ii) the nature of the hazard has changed or the level of risk has increased because of the software update; and iii) the product is made available (or put into service where this is covered by the specific Union harmonisation legislation).”Blue Guide 2022, section 2.1
This does give us more guidance on when a software change could be considered to be a substantial change to be evaluated by the notified body (which is not to be confused with a significant change to a legacy device as discussed in MDCG 2020-3 for MDR and MDCG 2022-6 for IVDR).
Making available on the market
There are basically no changes to this section, except a clarification of a principle that we already knew about:
“The concept of making available refers to each individual product, not to a type of product, and whether it was manufactured as an individual unit or in series.”Blue Guide 2022, section 2.2
This new paragraph clarifies a concept that is hard to understand for people that perceive market access on a per type basis, which is a misunderstanding. This new paragraph underlines that making available applies to each individual device and not to a series of devices covered under the same CE mark. If this were different, all logic underlying the MDR and IVDR vigilance and market surveillance provisions would break down, as this is targeted at individual products (although of course a batch or even a series can have the same problem).
Placing on the market
At the risk of sounding like a broken record I am going to again point out the glaring incoherence between language versions regarding the criteria for placing on the market that leads some people to think that transfer of a property right is a necessary condition for placing on the market. I have argued in detail why this is an unfortunate, unnecessary but easily remedied oversight, and that these mistakes also have propagated into MDCG guidance. The fact that the MDCG and the Commission have not fixed this mistake for one of the core concepts of NLF legislation eludes me and, with all due respect, it says a thing or two about their quality control on guidance.
The Blue Guide contains more detail on the concept of placing on the market and now actually contradicts itself even more if one persists in following the misguided theory that placing on the market requires transfer of a property right as a necessary condition, mainly because the English version of the Blue Guide uses these words (like the MDCG mistakenly does in MDCG 2021-27 and which many companies, consultant and lawyers are copying). Many other language versions, like other Commission working languages German and French, do not use this wording and do not state that a property right transfer is needed as a condition for placing on the market. In view of contradictory language versions this means according to EU Court case law that you cannot assume one of them is automatically right (or wrong). This is why we need a solution here. What is more, the new Blue Guide 2022 section 2.12 contains examples that demonstrate placing on the market without a transfer of a property right (e.g. example 2 and 6), which only increases the confusion.
There is a new paragraph in section 2.5 about placing on the market of imported products, which clarifies that placing on the market also applies to second hand products made available in the Union for the first time. If it’s the second time, e.g. in case of re-import after a product that was placed on the market already, then this is not placing on the market anymore, as was already clarified in the 2016 version of the Blue Guide.
Placing on the market is a crucial concept to get right under the MDR and IVDR with the crucial deadlines for legacy products coming up. I currently spend a large part of my professional time advising devices companies about this. Mind you: this is not only relevant for the end of the legacy device period (legacy device can still be placed on the market under article 120(3) MDR or article 110 (3) IVDR) but also for the one year sell-off period under article 120 (4) and 110 (4) IVDR (legacy device that was placed on the market can still be made available).
One of the things that I am working on at the moment is developing contractual solutions to deal with the situation towards the end of the sell-off period, where I (and many others) expect many manufacturers and importers/distributors not to have made all devices in their stocks available to the final customer yet and thus be stuck with stocks that they cannot make available further in the Union market anymore and that must be withdrawn from the supply chain. If the company does not have a credible argument that the devices still in stock have been made available to the final customer in time (so before end of the sell-off period for the medical device or IVD), the device concerned cannot be made available anymore to any final customer in the Union and must be withdrawn from the supply chain as the Commission explains in the relevant fact sheet. So better get this right and contact me for help if needed!
Making available and placing on the market in case of distance and online sales
Distance sales and online sales pose specific problems in relation to the concepts of making available and placing on the market. The MDR and IVDR solve these to an extent with article 6 MDR and IVDR by skirting the question for physical devices in article 6 (1): if you offer a device to an end user in the Union, it must meet the requirements of the MDR/IVDR, thus achieving what would be achieved if the device would be placed on the market. Article 6 (2) adds that devices provided as service to users in the Union must also meet the requirements of the MDR/IVDR, regardless of the location of the infrastructure that they are run from.
The Blue Guide 2022 adds additional interpretation in a new section 2.4 that is very relevant for companies selling devices online or at a distance.
“The physical delivery to end-users in the EU of a product ordered from a given online seller based outside the EU, including by a fulfilment service provider, gives irrefutable confirmation that a product is placed on the EU market.”Blue Guide 2022, section 2.4
This little sentence has a lot of consequences. While companies in the past would sometimes seek to argue that they did not place a product on the market but would still offer and sell it to consumers or other end users, the Blue Guide now contains a rule of proof that physical delivery to end users by necessisity assumes a product that is placed on the market.
Secondly, the Blue Guide provides another rule for interpretation of placing on the market where devices are sold via an FSP:
“Some products offered online or through other means of distance selling to end users in the Union are transferred first to fulfilment service providers located in the EU to guarantee their swift delivery to EU end users. Accordingly, products stored by such fulfilment service providers and released for free circulation are considered to have been supplied for distribution, consumption or use on the EU market and thus placed on the EU market. When an online operator uses a fulfilment service provider in this manner, by shipping the products to the fulfilment house in the EU, the products are in the distribution phase of the supply chain. These products are considered placed on the market at the time they are released for free circulation.”Blue Guide 2022, section 2.4
In other words: customs cleared and in the hands of your FSP means placed on the market in the Union (but not necessarily placed on the market by the FSP!). I think that this is not always correct however, because there is the distinction between devices held by the FSP that are intended for the Union market and those held by the FSP that are not intended for the Union market, which may both be customs cleared and sitting in an FSP warehouse. The latter group is of course not necessarily placed on the market because it is not intended for distribution in the Union.
Putting into service (and installation)
Putting into service is an elusive concept for many, but in fact simpeler than you think. It applies in situations where a device is not made available in its final form, in which case EU law requires another compliance gating when the device is set up to be used for the first time. Think MRI machine or bigger: these are not placed on the market as a single unit but need to be built up in place. The compliance of the device depends on whether the device is built up in place correctly, so naturally the device has to conform to CE marked specs when it’s ready for first use as intended, i.e. at the moment that it is put into service.
The Blue Guide contains a helpful clarification for the current grace period deadlines for legacy devices under the MDR and IVDR:
“Unless otherwise provided for in specific Union legislation, where products have been placed on the market in compliance with the Union harmonisation legislation applicable at that time, they can also be put into service even if that legislation has been amended after the products are placed on the EU market and therefore they do not entirely comply with the new EU legislation.”Blue Guide 2022, section 2.6
However, note that there is a lex specialis in the MDR and IVDR in article 120 (4) and 110 (4) about until when the devices can still be made available to end users during the sell-off period, as discussed above. Legacy devices that have not been made available to the final customer timely must be withdrawn from the supply chain.
Reasonably foreseeable and intended (mis)use
This section 2.8 is not new, but it does contain some new language that is very relevant for the application of the new article 7 MDR and IVDR about claims. Article 7 MDR and IVDR essentially oblige manufacturers to be precise about their claims and not use any claims that may mislead users and/or patients about the risks, safety and/or performance of the device. For those interested, I wrote a detailed article about article 7 MDR and IVDR in RAPS Focus.
This new Blue Guide language also underlines how crucial a proper formulation of intended purpose is, and how the manufacturer is expected to actively imagine how the user may use the device:
“Manufacturers have to look beyond what they consider the intended use of a product and place themselves in the position of the average user of a particular product and envisage in what way they would reasonably consider to use the product.
For products intended for outdoor use, they should also consider how projections about the changing climate in the EU will affect the safety and performance of the product during use. Since the climate is already changing, outdated assumptions based on historical observations and performance should be revised. If the product’s typical life-span extends beyond 5 years, manufacturers may want to prepare it also for more extreme conditions expected in the mid-term.”Blue Guide 2022, section 2.8
This language means that manufacturers cannot easily suffice with disclaimers and warnings as regards perceived intended purpose, because they also have to take into account that disclaimers may be overlooked or misinterpreted. More generally speaking I personally consider disclaimers and unclear warnings evidence of faulty formulation of intended purpose and faulty design flowing from that, because you are just creating gorilla doors:
Nobody likes gorilla doors, and as a lawyer I can say that they’re particularly hard to explain to authorities and judges because they are usually avoidable. Also, they lead to surprise and frustration on the part of users, and possible damage or sub-optimal outcomes on the part of patients.
Transitional arrangements for the EU Declaration of Conformity
There is an interesting new section 2.11 with guidance on how to work with declarations of conformity that cover the same device under different legislation, e.g. MDD and MDR. This section describes how to work with a DoC that declares conformity to both old and new legislation for a product.
Brexit, Swixit and Northern Ireland
Since 2016 the geographic scope of the Union in which NLF legislation and specifically devices regulation under the MDR and IVDR applies has changed considerably. The UK has left the EU and the MRAs for medical devices and IVDs that made Switzerland part of the European internal market for devices have expired in the mean time without replacement, putting Switzerland outside the Union.
One of the mistakes that many people continuously make is to equate the geographic scope of the Union referred to in the MDR and IVDR with that of the EU. You might consider updating your knowledge in that case if you market yourself an expert. It’s really like in the realm of saying that Alaska is a Canadian province, that Puerto Rico is a US state or that Amsterdam is the capital of Denmark. It is also implicitly stating that Switzerland was an EU member state, which it never was (but was in the Union for the purpose of EU medical devices and IVD law). It’s never to late to know that the Union referred to in the MDR and IVDR is bigger than the EU 27 member states (including some of their overseas territories), because it also includes the three EFTA states that are EEA signatories but not EU member states (Iceland, Norway, Liechtenstein), and includes Turkey, which is neither EU member state nor EEA signatory but has its own agreement with the EU.
All of this is also again reiterated in the Blue Guide 2022. Also, my book the Enriched MDR and IVDR (2nd edition imminent now) contains a fully updated ‘scope of Union’ commentary with an updated map, a discussion of the overseas areas of member states that are and are not Union for the purpose of MDR and IVDR as well as a discussion of the difference between the UK and Great Britain (being Northern Ireland in which EU NLF legislation still applies, see Blue Guide section 2.9.6 – if you read this you’ll also understand the current friction between the EU and the UK on the Northern Ireland protocol better) which you should know. Brexit is discussed in sections 2.9.5 and 9.3.
The relation with Switzerland is discussed in general terms in section 9.2.2 without mentioning specifically that the MRAs for medical devices and IVDs have expired by 26 May 2021 and 2022 respectively and Switzerland is not Union anymore for medical devices and IVDs, but may still be Union for products for which the MRAs have not expired since the EU has decided not to renew any MRA with the Swiss after Switzerland negotiated but then refused to ratify a comprehensive arrangement for all products in 2019.
The examples provided in new section 2.12 are quite useful, although I can appreciate that the logic may be hard to follow for some.
For example, there is a school of thought in the market that argues that placing on the market is a two-step process in the sense that a device cannot be considered placed on the market if the importer has not made it further available to into the supply chain. Interestingly this does not follow from the examples in section 2.12. Example 1 for example discusses the situation where a product is placed on the market immediately without importer involvement by means of a direct sale to an EU customer. In my opinion a two step proces can be used to demonstrate placing on the market (so it’s an option), but a two step process is not a requirement, as the Blue Guide 2022 shows.
It is important when looking at these examples to keep in mind that placing on the market (and making available as core concept in placing on the market) are very flexible concepts that can apply via any of the three nexuses (1) legal (e.g. change of ownership or offer to supply), (2) financial/tax/customs (e.g. customs clearance) and (3) physical (device is in Union territory). Any of these three nexuses can by itself lead to a conclusion of placing on the market. For this reason the theory that a transfer of property right is always needed for placing on the market makes no sense, as it would invalidate several the examples given in 2.12 (see also discussion above under Placing on the market).
So we have something old, something new, a number of somethings lex specialis and something blue (my hurt feelings because of the Commission not correcting the placing on the market language incoherence in the new Blue Guide).
So no radical changes – fortunately in a way, because we would have needed legislation for that – but still some interesting nuggets that may be useful in your specific case.
The amendments to Chapter 2 are also a reminder for companies in the devices space to make a plan and follow through (as Brian Boitano would do) on rational supply chain management with all the regulatory deadlines in sight to avoid nasty surprises that can seriously ruin your party. You probably don’t want to be the person to tell your management that the company made totally avoidable but very costly mistakes that cause withdrawals, recalls and can lead to enforcement for placing on the market/making available of devices or IVDs in infringement of regulatory deadlines.
Next up: discussion of economic operators and their obligations in Chapter 3.