Source: https://johner-institute.com/articles/regulatory-affairs/and-more/systems-procedure-packs/
Timestamp: 2019-04-26 07:56:14+00:00

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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.
1. Systems and procedure packs: what are they?
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).
Fig. 1: There are combinations of products that are both a system and a procedure pack, and combinations that are only a system or only a procedure pack.
The Health Products Regulatory Authority has published a helpful "Guide to Placing System and Procedure Packs on the Market" .
c) Are hospital information systems systems or procedure packs?
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.
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).
2. Which regulatory requirements have to be followed?
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.
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”.
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.
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.
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”.
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 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.
(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.
(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.
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.
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.
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.
“Systems and procedure packs as referred to in Article 22 shall be assigned and bear their own UDI”.
6.3.2. Device contents of system or procedure packs shall bear a UDI carrier on their packaging or on the device itself.
(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.
(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.
Systems and procedure packs can include non-medical devices.
Manufacturers must confirm that they have verified and validated such “combinations”, which in turn requires, among other things, specifications that can be used for the verification and validation.
Systems and procedure packs require their own UDI.
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.
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.
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.
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.

References: §10
 §7
 §10
 § 25
 § 10
 § 37
 § 7
 § 10
 § 10