The European legislation defines systems and procedure packs and distinguishes between different configurations. The regulatory requirements placed on the manufacturer are heavily dependent on these configurations.
This article will explain to you what legislators understand by systems and procedure packs, what the most important legal requirements are for manufacturers, and what common errors you should avoid.
Both the German Medical Devices Act (MPG) and the EU's Medical Devices Directive (MDD) set requirements for the marketing of systems and procedure packs. But neither defines the terms. The EU Medical Device Regulation (MDR) – not to be confused with the German Medical Device Regulation (MPV) – makes up for this omission:
‘System’ means a combination of products, either packaged together or not, which are intended to be inter-connected or combined to achieve a specific medical purpose;
The MDR also defines the term “procedure pack”.
The definitions make it clear that there is an overlap between systems and procedure packs (see Fig. 1).
The definitions make it clear that there is an overlap between systems and procedure packs (see Fig. 1).
Examples of combinations of products that are systems and procedure packs:
Examples of combinations of products that are systems but not procedure packs:
Examples of combinations of products that are procedure packs but not systems:
The Health Products Regulatory Authority has published a helpful "Guide to Placing System and Procedure Packs on the Market" .
A Court of Justice of the European Union (CJEU) decision ruled that hospital information systems (HIS) can be non-medical devices but may contain modules that are classified as medical devices. In this context, we are then faced with the question of whether such an HIS is a system or procedure pack according to the legal definition.
A detailed expert opinion analyses whether hospital information systems should be considered as systems or procedure packs.
Combinations of medical devices and medicinal products or biological products are considered “combination products” and do not fall under the definition of “systems and procedure packs”.
IEC 60601-1 also talks about systems, or more precisely “medical electrical systems” (ME systems, for short). It defines these as follows.
“Combination, as specified by its manufacturer, of items of equipment, at least one of which is a medical electrical system to be inter-connected by functional connection or by use of a multiple socket-outlet”
Source: IEC 60601-1 Kapitel 3.64
In contrast to the definition of systems in the MDR, medical electrical systems are not necessarily supplied by the manufacturer as “systems”. Instead, it is often the operators who assemble the ME systems.
The manufacturer can deliver an ME system as a medical device comprising several “components” or as a system as defined by the Medical Device Regulation (MDR).
European jurisprudence consists of, firstly, the medical device directives that have to be transposed into national (medical device) law, and the EU medical device regulations (MDR, IVDR). This section describes the regulatory requirements that manufacturers who market systems or procedure packs must comply with.
In Article 12, the Medical Devices Directive (MDD) requires manufacturers of systems and procedure packs to draw up a declaration by which it states that:
he has verified the mutual compatibility of the devices in accordance with the manufacturers' instructions and has carried out his operations in accordance with these instructions; and he has packaged the system or procedure pack and supplied relevant information to users incorporating relevant instructions from the manufacturers; and the whole activity is subjected to appropriate methods of internal control and inspection.
The MDD does not talk about manufacturers. The fact that the requirements apply indirectly to manufacturers is a result of the German transposition of these requirements into MPG §10(1) and MPV §7(6). Only the latter talks about the manufacturer who has to issue the declaration.
Manufacturers do not have to carry out (another) conformity assessment for these systems and procedure packs. However, the legislation presupposes that the products put together will bear CE marking and will be put together and used “within their intended purpose”.
The MDD defines “devices” as follows:
“Both medical devices and accessories shall hereinafter be termed devices.”
Source: MDD, Article 1
Therefore, the MDD only refers to medical devices and accessories, not IVDs.
As soon as the combination contains a device that is not used according to the intended purpose or one that has not been marketed in accordance with the MDD, this combination (without a conformity assessment procedure) may not be marketed as a system or procedure pack.
Manufacturers must ensure that the declarations are “kept at the disposal of competent authorities for a period of five years”. The German Medical Devices Act with its national regulations regulates this in more detail.
It seems that the authorities themselves are not sure when such a declaration has to be made. The head of a regional council wrote to one of the Johner Institute's clients to say:
We have re-examined the process and, in consultation with the other regional councils, we have decided not to accept an additional notification as a system assembler for the manufacturer declaration.
The reason for this is that the compatibility of the accessory software with the main software must already have been proven as part of the conformity assessment procedure. We therefore consider a declaration as the party responsible for assembling systems or procedure packs necessary only if you are not the manufacturer as defined by the MPG of at least one medical device in the system.
The legal basis for this assessment is not clear from the text. However, this loose interpretation seems to be conclusive and should be in the minds of a lot of manufacturers.
The German Medical Devices Act transposes Article 12 of the MDD into German law through § 10. The relevant part of the law states:
(1) Medizinprodukte, die eine CE-Kennzeichnung tragen und die entsprechend ihrer Zweckbestimmung innerhalb der vom Hersteller vorgesehenen Anwendungsbeschränkungen zusammengesetzt werden, um in Form eines Systems oder einer Behandlungseinheit erstmalig in den Verkehr gebracht zu werden, müssen keinem Konformitätsbewertungsverfahren unterzogen werden. Wer für die Zusammensetzung des Systems oder der Behandlungseinheit verantwortlich ist, muss in diesem Fall eine Erklärung nach Maßgabe der Rechtsverordnung nach § 37 Abs. 1 abgeben.
In §10(4), the MPG prohibits additional CE markings being affixed to systems and procedure packs, and requires that necessary information be provided by the marketer of the system or procedure pack.
The MPG also stresses that a conformity assessment procedure for a system or procedure pack can only be omitted if the system or procedure pack only includes medical devices used in a way that is compatible with the original intended purpose.
The MPG firms up this obligation to notify the authorities in § 25 “General obligation to notify”.
(2) Wer Systeme oder Behandlungseinheiten nach § 10 Abs. 1 zusammensetzt oder diese sowie Medizinprodukte nach § 10 Abs. 3 sterilisiert und seinen Sitz in Deutschland hat, hat der zuständigen Behörde unter Angabe seiner Anschrift vor Aufnahme der Tätigkeit die Bezeichnung sowie bei Systemen oder Behandlungseinheiten die Beschreibung der betreffenden Medizinprodukte anzuzeigen.
Accordingly, those responsible for putting together systems or procedure packs, i.e. assemblers, must notify the competent authority.
In other words, manufacturers must notify the German Institute of Medical Documentation and Information (DIMDI), which then forwards the notification to the state authority responsible for registration.
We have had it confirmed to us by the Trade Supervisory Board of the Government of the Upper Palatinate that manufacturers have to report systems and procedure packs to the DIMDI via its website.
The aforementioned § 10 MPG refers to the corresponding legal regulation according to § 37 of the law. This legal regulation is the Medical Device Ordinance (MPV) in the version dated 9/27/2016, including § 7 “Conformity assessment procedure for other Medical Devices”.
(6) Für Systeme und Behandlungseinheiten nach § 10 Abs. 1 des Medizinproduktegesetzes hat der Hersteller die Erklärung nach Artikel 12 Abs. 2 Satz 1 der Richtlinie 93/42/EWG auszustellen. Die Erklärung ist mindestens fünf Jahre und im Falle von implantierbaren Produkten mindestens 15 Jahre aufzubewahren. Für Systeme und Behandlungseinheiten nach § 10 Abs. 2 des Medizinproduktegesetzes gelten die Vorschriften der Absätze 1 bis 4 entsprechend.
EK-Med also discusses the topic of systems and procedure packs, for example in Document 3.10 A 15. It discusses what happens if the devices all have CE marking and are used for their intended purpose, but procedures are used (e.g. during packaging) that influence the product quality.
The European Medical Device Regulation (MDR) takes the concepts in the MDD further. It contains Article 22 “Systems and procedure packs” and Article 29 “Registration of products”. The MDR also regulates how to process the UDI.
Article 22 “Systems and procedure packs”
Article 22 of the MDR corresponds to Article 12 of the MDD. However, in paragraph (1) c) it opens the door to “other devices” and for in vitro diagnostics.
Natural or legal persons shall draw up a statement if they combine devices bearing a CE marking with the following other devices or products, in a manner that is compatible with the intended purpose of the devices or other products and within the limits of use specified by their manufacturers, in order to place them on the market as a system or procedure pack:
(a) other devices bearing the CE marking;
(b) in vitro diagnostic medical devices bearing the CE marking in conformity with Regulation (EU) 2017/746;
(c) other products which are in conformity with legislation that applies to those products only where they are used within a medical procedure or their presence in the system or procedure pack is otherwise justified.
So it makes clear that non-medical devices as well as medical devices can be placed on the market as a system or procedure pack.
Non-medical devices must comply with applicable (European) legislation. Examples of such legislation include EU regulations and EU directives, such as REACH (1907/2006/EC) and the Radio Equipment Directive (2014/53/EU).
Paragraph (2) also requires the declaration, which must now be somewhat more precise and with which the manufacturer must confirm that it has provided the necessary information and has carried out appropriate monitoring, verification and validation.
In the statement made pursuant to paragraph 1 the natural or legal person concerned shall declare that:
(a) they verified the mutual compatibility of the devices and, if applicable other products, in accordance with the manufacturers’ instructions and have carried out their activities in accordance with those instructions;
(b) they packaged the system or procedure pack and supplied relevant information to users incorporating the information to be supplied by the manufacturers of the devices or other products which have been put together;
(c) the activity of combining devices and, if applicable, other products as a system or procedure pack was subject to appropriate methods of internal monitoring, verification and validation.
The MDR requirement in Article 22(2)(3) on “Product verification and validation” goes further than the MDD requirements in Article 12(2)(c). According to the MDD, the manufacturer “only” has to confirm that “the whole activity is subjected to appropriate methods of internal control and inspection”.
Verification and validation implicitly requires specifications that can be used by the manufacturer for verification and validation. This in turn requires a specification for the “combined” system. The MDD does not contain such (indirect) requirement.
Paragraph (4) states:
Where the system or procedure pack incorporates devices which do not bear the CE marking or where the chosen combination of devices is not compatible in view of their original intended purpose, or where the sterilisation has not been carried out in accordance with the manufacturer's instructions, the system or procedure pack shall be treated as a device in its own right and shall be subject to the relevant conformity assessment procedure pursuant to Article 52. The natural or legal person shall assume the obligations incumbent on manufacturers.
The MDD requires a new conformity assessment for systems or procedure packs that include:
On the other hand, the MDR requires a new conformity assessment for systems or procedure packs that include:
In contrast to the MDD (as shown above), the MDR no longer directly rules out the combination of a medical device with a non-medical device without a new conformity assessment.
Article 29 “Registration of devices”
An additional requirement contained in the MDR compared to the MDD is that manufacturers must assign a UDI to the system or procedure pack and enter it in the EUDAMED:
2. Before placing on the market a system or procedure pack pursuant to Article 22(1) and (3), that is not a custom-made device, the natural or legal person responsible shall assign to the system or procedure pack, in compliance with the rules of the issuing entity, a Basic UDI-DI and shall provide it to the UDI database together with the other core data elements referred to in Part B of Annex VI related to that system or procedure pack.
Annex VI describes these requirements in more detail.
UDI: Annex VI Part C
The MDR defines the Unique Device Identification (UDI) in paragraph 3.7 of Annex VI:
“Systems and procedure packs as referred to in Article 22 shall be assigned and bear their own UDI”.
In 6.3.1, it specifies:
“The natural or legal person referred to in Article 22 shall be responsible for identifying the system or procedure pack with a UDI including both UDI-DI and UDI-PI.”
Finally, the MDR also regulates where the UDI has to be applied:
6.3.2. Device contents of system or procedure packs shall bear a UDI carrier on their packaging or on the device itself.
(a) Individual single-use disposable devices, the uses of which are generally known to the persons by whom they are intended to be used, which are contained within a system or procedure pack, and which are not intended for individual use outside the context of the system or procedure pack, shall not be required to bear their own UDI carrier;
(b) devices that are exempted from bearing a UDI carrier on the relevant level of packaging shall not be required to bear a UDI carrier when included within a system or procedure pack.
6.3.3. Placement of the UDI carrier on systems or procedure packs
(a) The system or procedure pack UDI carrier shall as a general rule be affixed to the outside of the packaging.
(b) The UDI carrier shall be readable, or, in the case of AIDC, scannable, whether placed on the outside of the packaging of the system or procedure pack or inside transparent packaging.
Summary of changes made by the MDR
The main changes introduced by the MDR compared to the MDD are:
The FDA still uses the term “convenience kits”:
“Convenience kit means two or more different medical devices packaged together for the convenience of the user.”
Source: FDA 21 CFR 801.3
This is a bit like a procedure pack, although the definition of a procedure pack does not specify whether the packaging together of the medical devices is for convenience or not. The devices packaged together in a convenience kit are not necessarily (all) used for a single medical purpose.
Examples of convenience kits are first aid kits or sets of devices that have been packaged together for a particular operation. The FDA published the requirements for the assignment of a UDI to these kits in its “UDI Convenience Kits” guidance document.
The FDA still also uses the term “device packages”:
„Device package means a package that contains a fixed quantity of a particular version or model of a device.“
Source: FDA 21 CFR 801.3
However, this does not correspond to the systems and procedure packs as defined in the European legislation.
Compared to the MDD, the MDR has simplified the requirements in the sense that systems and procedure packs may contain non-medical devices. These must be verified and validated by the manufacturers in accordance with the MDR; this was not required so explicitly by the MDD.
Unlike the MDD, the MDR does not need to be transposed into national law. When asked how well the MDD succeeded in doing this, Dr. Banz came to the conclusion that:
“[...] it is almost impossible to fulfill the requirements and overcome the hurdles created by the literal application of §10(2). These difficulties, together with the absence of any justification by the legislative authorities for going beyond the framework established in Article 12(2), sentence 2 of the MDD, lead to the conclusion that the directive may after all be imprecisely implemented in national law.”
You can read the full article by Banz/Eckle/Kremser on “Systemen und Behandlungseinheiten und Ihre Behandlung nach dem Medizinprodukterecht” [Systems and procedure packs and how to handle them in accordance with medical device law] online and in MPR2/2009 p. 50ff.
The fact that the authorities themselves disagree on when a declaration has to be made (see above) regarding a system or procedure pack creates further legal uncertainty.
A lot of manufacturers are unaware of the regulatory requirements they must meet if they want to sell systems and procedure packs. Armin Gärtner writes to us:
“Regulatory authorities are increasingly demanding Article 12 declarations in hospitals, e.g. for endoscopy equipment trolleys and for other systems supplied by a manufacturer. Unfortunately, a lot of manufacturers are simply unaware of this. Others shift the responsibility for putting together products sold individually onto hospitals, which usually do not know or understand this.”
This article has not discussed combination products (medical devices and medicinal products). Nor has it looked at when it makes more sense to market devices individually, as systems or procedure packs or as one device.