Regulatory requirements for systems and procedure packs under the MDR
December 9, 2021
Different (medical) products can be combined into a package and placed on the market. These packages are called systems or procedure packs, for which there are separate regulatory requirements. This was already possible under Directive 93/42/EEC for medical devices (MDD) and will continue to be possible under Regulation EU 2017/745 for medical devices (MDR), which has been in force since May 26, 2021 - albeit with some changes.
Overview of new MDR requirements
This article is aimed at manufacturers of systems and procedure packs to give them an overview of new MDR requirements so that the requirements can be planned and implemented at an early stage. In this way, the (system) manufacturer can continue to place the products on the market in combination without any problems.
Systems and procedure packs under MDD 93/42/EEC
Under the Medical Devices Directive 93/42/EEC (MDD), it was already possible to package different products together and place them on the market as a system or procedure pack. The MDD clearly required that the products packaged together must be CE-marked medical devices. This excluded in-vitro diagnostics and other products with CE marking (non-medical devices). In addition, the assembly had to be carried out in accordance with the intended purpose of the individual products and within the application restrictions specified by the manufacturer. To place a system or procedure pack on the market, the (system) manufacturer did not have to go through its own conformity assessment procedure. It only had to prepare a declaration in accordance with Article 12 of the MDD confirming that
- the mutual compatibility of the products was checked in accordance with the manufacturer's instructions and the work steps were carried out in accordance with the instructions.
- the system or procedure pack has been packaged and relevant user instructions, including the relevant manufacturer’s instructions, have been taken into account.
- the entire packing activity has been appropriately monitored and controlled internally.
One key aspect was missing in the MDD
Many (system) manufacturers searched in vain for a definition of systems and procedure packs in the MDD definitions. Thus, under the MDD, the question of what a system or procedure pack actually is and which product combinations fall under it was open. This lack of clarity provided a lot of room for interpretation between (system) manufacturers and the notified bodies. This gap is now being filled with the new EU Regulation 2017/745 for medical devices (MDR).
Definitions for systems and procedure packs under the MDR
The MDR also contains a definition of systems and procedure packs under the definitions in Article 2, points 10 and 11. Accordingly, a procedure pack is a combination of products packaged together and placed on the market that are intended for use for a specific medical purpose.
Timo Bohnhoff, qtec Experte
Requirements for systems and procedure packs according to Article 22 of the MDR
The requirements for systems and procedure packs are regulated in Article 22 of the MDR. There is a welcome difference for (system) manufacturers compared to the MDD. With the MDR, in-vitro diagnostics with CE marking in accordance with Regulation (EU) 2017/746 and other products with CE marking (i.e. non-medical devices) can now be packaged together within a system or procedure pack without having to go through a separate conformity assessment procedure. However, the prerequisite here is that the products are assembled in accordance with the intended purpose of the individual medical or other products and within the application restrictions specified by the manufacturer. This innovation now offers (system) manufacturers more scope for maneuver in combining products within a system or procedure pack, as other products can now also be added alongside medical devices.
A declaration in accordance with Article 22 from the (system) manufacturer is also required under the MDR. The content of this declaration is almost similar to the requirements of the already known Article 12 of the MDD. However, there is a significant extension that manufacturers of systems and procedure packs should be aware of and observe. Under point 2 c), in addition to the internal monitoring and control of the appropriate methods for assembling the products, verification and validation of the assembly is now also required. The extension of this paragraph therefore means that (system) manufacturers have to incur additional work that was not previously explicitly required under the MDD. This means that manufacturers of systems and procedure packs must now also deal with the processes of verification and validation, as well as create specifications against which verification and validation can be carried out.
Please also note our qtec blog post „Difference between verification and validation“.
When is an independent conformity assessment procedure necessary?
As soon as the previously mentioned requirements of Article 22, points 1 and 2 are deviated from, a declaration in accordance with Article 22 by the (system) manufacturer is not sufficient. This is the case if the system or procedure pack contains products that do not bear the CE marking. The declaration is also not sufficient if the combination of the products and the intended purpose of the system or procedure pack does not correspond to the original intended purpose of the individual products. This also includes sterilization of the system or procedure pack if this is not carried out in accordance with the instructions of the manufacturers of the individual products.
If one of these aspects applies, the system or procedure pack is treated as a separate product, so that the (system) manufacturer must carry out a relevant conformity assessment procedure in accordance with Article 52 of the MDR. This puts the (system) manufacturer in the role of manufacturer in accordance with Article 2, point 30, including its extensive obligations in accordance with Article 10 of the MDR.
Marking and identification of systems and procedure packs
Systems and procedure packs that meet the requirements of Article 22 of the MDR and for which a declaration from the (system) manufacturer is available are not provided with an additional CE mark. However, they must contain the name and address of the (system) manufacturer. Furthermore, the requirements for labeling and information to be provided with the product specified in Annex I, Section 23 also apply to systems and procedure packs.
Systems and procedure packs must have their own Unique Device Identification (UDI) for unambiguous identification (Annex VI, Part C, Point 3.7 of the MDR). The (system) manufacturer is responsible for this. More detailed information and requirements are provided in Point 6.3 with its sub-points 6.3.1 - 6.3.3 of Annex VI, Part C of the MDR. This regulates where and how the UDI is to be affixed to systems and procedure packs, including possible exceptions.
The guideline of the Medical Device Coordination Group (MDCG) in its MDCG document 2018-3 Rev.1 entitled Guidance on UDI for systems and procedure packs can provide assistance for (system) manufacturers in this regard. In addition to examples of systems, procedure packs and economic operators that are not to be understood as (system) manufacturers, there is also information on the registration and UDI marking of systems and procedure packs.
Registration of the system or procedure pack and its manufacturer
After assigning a basic UDI for the manufacturer’s system or procedure pack in accordance with Article 29, point 2 of the MDR, the (system) manufacturer must enter this together with the other product and manufacturer information from Annex VI, Part B of the MDR in the central European database for medical devices (EUDAMED).
In order to comply with this obligation, the (system) manufacturer must first register itself in EUDAMED under the so-called Actor Registration Module as a producer of systems and procedure packs. The (system) manufacturer will then receive a Single Registration Number (SRN) in accordance with Article 31 of the MDR from its competent authority. It is important to note that manufacturers who take on the role of manufacturer in accordance with Article 2, point 30 of the MDR and also assemble systems or procedure packs must also register twice in EUDAMED. They will therefore also receive two SRNs for their two roles.
Conclusion
The new EU regulation 2017/745 for medical devices (MDR) also brings changes to the requirements for systems and procedure packs. The MDR not only creates clarity with definitions in the terminology, but can also bring advantages and more flexibility in the combination of products for (system) manufacturers. However, the MDR can also lead to more effort and costs, as (system) manufacturers now have to meet requirements, e.g. for verification and validation, that were not explicitly required before. Manufacturers of systems and procedure packs should deal with the innovations brought about by the MDR and start implementing them at an early stage in order to be able to guarantee the seamless availability of their systems and procedure packs.
Comprehensive conformity assessment procedure or manageable manufacturer's declaration?
The answer to this question has a significant impact on time planning and budgeting for you as a manufacturer of systems and treatment centers. It should therefore be carefully examined and answered.
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