Page Last Updated: 20 December 2023

Definitions: Systems, Procedure Packs, Kits

Systems and Procedure Packs

MDR, Article 2(10): “‘procedure pack’ means a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose”

MDR, Article 2(11): “‘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”

A procedure pack could contain only medical devices; however, a procedure pack could also contain other product types, covered by different legislation. For example, Personal Protective Equipment Regulation (PPE) or in vitro diagnostic (IVD) devices compliant with the IVD Directive (IVDD) or Regulation (IVDR).

Generally, Systems/Procedure Packs are not considered medical devices in their own right, are not CE Marked. And System/Procedure Pack Producers are not subject to the same requirements as medical device Manufacturers (as defined by the MDR). Exceptions apply, however; more on this is covered in the sections below.

IVD Kits

Unlike the MDR, the IVDR does consider IVD kits as medical devices in their own right.

IVDR, Article 2(11): “‘kit’ means a set of components that are packaged together and intended to be used to perform a specific in vitro diagnostic examination, or a part thereof;”

IVDR, Article 2(2): “‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system’ … ”

Therefore, IVD kits are treated on an equal basis with all other IVD medical devices. are CE Marked, and are subject to the same requirements.

The IVDR does not specify what type of components can, or cannot, be packaged together in a kit. However, EU guidance MEDDEV 2.14/1 Rev. 2* states that IVD kits may contain products that are CE Marked in their own right, either as IVDs or medical devices (e.g., lancets, swabs) and/or non-medical products (e.g., chewing gum added to induce a patient reaction in order to obtain a specific sample).

*While the MEDDEVs were drafted for the old Directives (MDD/AIMDD/IVDD), some of them are still considered a useful resource when there are gaps between the MDR/IVDR, and guidance documents published specifically for the MDR/IVDR. For example, several MDR clinical evaluation guidance (MDCG) documents still refer back to MEDDEV 2.7/1 rev. 4 on clinical evaluation.

Examples: Systems/Procedure Packs and Kits

Procedure Packs – first aid kits, orthodontic procedure packs, and skin traction kits

Systems – x-ray systems

IVD Kits – combination of reagents with consumables, such as specimen containers

S/PP ‘Producer’ vs ‘Manufacturer’

Systems and Procedure Packs

Both System/Procedure Pack Producers and Manufacturers are considered ‘Economic Operators’ under the MDR and each must meet certain obligations. However, these are two different, separate roles.

A ‘manufacturer’ is a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured, or fully refurbished, and markets that device under its name or trademark.

Generally, a System/Procedure Pack ‘Producer’ is a natural or legal person who places a system or procedure pack on the market. The MDR does not use the term ‘Producer’; however, this term is defined and used in MDCG 2018-3, Guidance on UDI for systems and procedure packs:

“For the purpose of this guidance and operations related to EUDAMED, the natural or legal person referred to in Article 22(1), 22(2) and 22(3) of the Medical Device Regulation shall be called the “system or procedure pack producer”.”

Under certain conditions, a System/Procedure Pack ‘Producer’ may become a ‘Manufacturer’. In this case, they are subject to the same legal obligations as a medical device manufacturer, including carrying out the relevant conformity assessment procedure for the System/Procedure Pack. The System/Procedure Pack then becomes a medical device in its own right.

Those circumstances are:

All Economic Operators (manufacturers, system/procedure pack producers, authorized representatives, importers, and distributors) are subject to MDR Articles 94, 95, and 97, on investigating and dealing with devices presenting an unacceptable risk to health and safety, and ‘other non-compliance’.  

IVD Kits

The IVDR does not identify a separate Economic Operator role for kit ‘producers’, i.e., they are manufacturers as defined by the IVDR, and subject to the same obligations.  

CE Marking & CE Marking Symbol

Systems and Procedure Packs

Generally, Systems/Procedure Packs are not CE Marked. Per MDR Article 22(5):

“[systems and procedure packs] shall not themselves bear an additional CE marking but they shall bear the name, registered trade name or registered trademark of the person referred to in paragraphs 1 and 3 of this Article as well as the address at which that person can be contacted, so that the person’s location can be established.”

Under certain situations, however, the system/procedure pack will be considered a device in its own right and must be CE Marked. Those are:

Under these conditions, the device must undergo the appropriate conformity assessment procedure (which may require Notified Body assessment) and the legal or natural person placing the product on the market is no longer a System/Procedure Pack Producer, and instead becomes a medical device manufacturer, bearing all the same legal obligations.

IVD Kits

IVD Kits are in vitro diagnostic medical devices in their own right and must be appropriately CE Marked.

Technical Documentation File

Systems and Procedure Packs

Systems/Procedure Packs do not require a Technical Documentation File as outlined for medical devices in the MDR.

However, System/Procedure Pack Producers should maintain the following documentation:

The MDR does not define a term for the above documentation. However, MedTech Europe uses the phrase ‘Procedure Pack File (PPF)’ to differentiate it from a medical device Technical Documentation File.

IVD Kits

IVD Kits are medical devices in their own right and are obligated to generate Technical Documentation Files as outlined in the IVDR.

Classification

Systems and Procedure Packs

Systems/Procedure Packs are not classified, i.e., do not hold an individual risk classification.

That said, for a variety of reasons, manufacturers may need to apply a risk classification anyway. For example:

In these situations, the manufacturer should apply the classification of the highest-risk device within the System/Procedure Pack.

IVD Kits

Kits are in vitro diagnostic medical devices and therefore classified according to risk. Please refer to the IVDR Annex VIII for the classification rules and MDCG 2020-16 ‘Guidance on Classification Rules for in vitro diagnostic devices under the IVDR’.

MDD/AIMDD Legacy Devices

A System/Procedure Pack may contain only legacy MDD/AIMDD devices, only MDR CE Marked devices, or a combination of both.

If the System/Procedure Pack contains only legacy devices, then it will be treated as a legacy System/Procedure Pack. i.e., continue to be marketed under Article 12 of the MDD, plus the additional requirements under MDR Article 120(3) for legacy devices, e.g., registration of economic operators and devices.

If the System/Procedure Pack contains only MDR devices, then it will be subject to Article 22 of the MDR.

If the System/Procedure Pack contains a mix of both legacy and MDR devices, then it will be subject to Article 22 of the MDR; however, the legacy devices contained within it will still be governed by the transitional provisions of Article 120(3).

This is addressed in MDCG 2021-25:

“It appears logical to apply the transition period also to systems and procedure packs consisting only of ‘legacy devices’ and for which a declaration has been drawn up in accordance with the MDD prior to 26 May 2021. In such cases, Article 22 MDR does not apply. Legal or natural persons combining ‘legacy devices’ with MDR devices (e.g. class I devices that are not covered by Article 120(3) are subject to Article 22 MDR, whereas the ‘legacy devices’ as such included in a system or procedure pack fall under the transitional provisions of Article 120(3) MDR.“

The key is that the medical devices within it have, and maintain, CE marking. Otherwise, the System/Procedure Pack becomes a medical device and must undergo conformity assessment.

Per MDR Article 22(4):

“Where the system or procedure pack incorporates devices which do not bear the CE…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.”

MDD vs MDR Requirements

The changes between the Medical Devices Directive (MDD) 93/42/EEC, Article 12, and the MDR 2017/745, Article 22 are not vastly different. The changes are mainly related to adding additional controls and centralizing requirements. For example, the MDD allowed each Competent Authority to request registration (or not) at their discretion. The MDR makes registration of all Systems/Procedure Packs in EUDAMED mandatory.

Key changes under the MDR:

Inclusion of Non-medical Products

Systems and Procedure Packs

Non-medical products are allowed in a System/Procedure Pack, if they are used within a medical procedure and in conformity with their applicable legislation; or, as long as their presence is otherwise justified.

Per MDR Article 22(1)(c), a System/Procedure Pack may contain:

“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.”

EU Authorized Representative (EC Rep)

Systems and Procedure Packs

While there is often confusion on this topic, the consensus is that an EU Authorized Representative (AR) is not required for System/Procedure Packs as defined under the MDR.

Article 22 does not state an EU AR is required. Further, EU guidance document MDCG 2021-13 on EUDAMED registration states:

“Please note that SPPP [System/Procedure Pack Producers] located in a non-EU country do not have an obligation to designate an AR [Authorized Representative]. Therefore, the SPPP should consider providing additional relevant information to the CA [Competent Authority], in order to facilitate the verification of the data provided for the purpose of the registration request.”

Of course, the CE Marked medical devices within the System/Procedure Pack may have EU ARs appointed, if the manufacturer of those individual devices is located outside of the EU. However, the System/Procedure Pack as a whole does not require its own separately appointed EU AR.

NOTE: Both the UK MHRA and Swissmedic do require the appointment of a local representative. Please refer to the below UK and Switzerland sections for more information.

IVD Kits

IVD Kits are in vitro diagnostic medical devices and are subject to the obligations under the IVDR. This includes the appointment of an EU AR if the manufacturer is located outside of the EU.  

Labeling

Systems and Procedure Packs

Per MDR Art 22(5), Systems/Procedure Packs are subject to the following labeling requirements:

IVD Kits

As IVD Kits are medical devices in their own right, they are subject to the full labeling requirements under the IVDR. Including sections 20.2(s) on labeling and 20.4(ag) on the instructions for use:

“where device kits include individual reagents and articles that are made available as separate devices, each of those devices shall comply with the labelling requirements contained in this Section and with the requirements of this Regulation”

UDI & Basic UDI-DI

Systems and Procedure Packs

Yes, Systems/Procedure Packs require compliance with UDI requirements under the MDR, including obtaining a Basic UDI-DI, applying the UDI carrier on the label, and registering in the EUDAMED UDI/Devices module.  

Per MDR Article 29(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.”

And MDR Annex VI, Part C, 3.7:

“Systems and procedure packs as referred to in Article 22 shall be assigned and bear their own UDI.”

IVD Kits

As IVD Kits are medical devices in their own right, they are subject to the full UDI requirements under the IVDR. This includes that kits will be assigned and bear their own UDI.

S/PP Statement: What Needs to Be Included?

Systems and Procedure Packs

MDR Article 22(1) and (2) requires that the System/Procedure Pack Producer shall draw up a statement confirming 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.“

Further, MDR Article 22(5) states:

“The statement…shall be kept at the disposal of the competent authorities, after the system or procedure pack has been put together, for the period that is applicable under Article 10(8)* to the devices that have been combined. Where those periods differ, the longest period shall apply.“

There is no explicit requirement to sign and/or date statement, or to add the EUDAMED Actor ID or Basic UDI-DI, as is specifically required in a Declaration of Conformity. However, there is nothing which prohibits the System/Procedure Pack Producer from including these additional identifying details if they wish.

*MDR Article 10(8) states documentation must be kept at least 10 years after the last device covered by the EU Declaration of Conformity has been placed on the market. Unless the device is implantable, in which case the period shall be at least 15 years after the last device has been placed on the market.

IVD Kits

IVD Kit manufacturers will generate a Declaration of Conformity per IVDR Annex IV.

Vigilance

Systems and Procedure Packs

The MDR does not provide a clear understanding regarding vigilance reporting, including if it is required at all for Systems/Procedure Packs. Industry needs more guidance from the Medical Device Coordination Group (MDCG) and/or the EU Competent Authorities regarding this.

That said, the best practice is for the device manufacturer and the System/Procedure Pack Producer to include vigilance reporting obligations within their agreement.

Where there is an incident reported regarding a device within the system/Procedure Pack, the System/Procedure Pack Producer should immediately notify the manufacturer so they can investigate. If the cause of the incident was due to the device, then the manufacturer will report it as per their vigilance procedure. Similarly, if a manufacturer becomes aware of an incident, they should in turn notify the System/Procedure Pack Producer.

Where the incident is directly related to the System/Procedure Pack Producer (e.g., due to the combination, sterilization, or other processing made by the Producer) then the responsibility falls to them. However, in this situation, the MDR does not indicate that the System/Procedure Pack has obligations to report. The MDR only has reporting obligations identified for the Manufacturer, which is a different Economic Operator role than the System/Procedure Pack Producer.

Certainly, at the very least, the System/Procedure Pack Producer should assess if the incident impacts the “mutual compatibility of the devices”.

IVD Kits

IVD Kits are medical devices and subject to the vigilance reporting requirements outlined under the IVDR.

Registering in EUDAMED

Systems and Procedure Packs

System/Procedure Pack Producers must register themselves in the EUDAMED Actor module and the Systems/Procedure Packs in the EUDAMED UDI/Devices module.  

The process for System/Procedure Pack Producers is slightly different from manufacturers. The reason is that, unlike non-EU manufacturers, System/Procedure Pack Producers are not obligated to appoint an EU Authorized Representative (AR).

A non-EU manufacturer would submit their EUDAMED Actor registration to the Competent Authority where their EU AR is located. First, the EU AR will review the EUDAMED Actor registration request, and then their Competent Authority will provide the final approval.

Since System/Procedure Pack Producers do not have an EU AR, they will instead have to select a national Competent Authority based on the following criteria:

Where a company is both a Manufacturer and a System/Procedure Pack Producer, they will register in the EUDAMED Actor module twice, submitting a separate application for each role.

NOTE: EUDAMED is currently voluntary; its mandatory use date has been postponed. For the most current understanding of EUDAMED’s deadlines, please read: EU Commission Proposes EUDAMED Gradual Rollout

IVD Kits

IVD Kits are medical devices in their own right, and there is no separate Economic Operator/Actor role. I.e, there is no equivalent of the System/Procedure Pack Producer for IVD Kits manufacturers. Instead, they are a manufacturer, as defined by the IVDR, and will register any IVD Kits marked under their name.

Importer / Distributor Obligations

UK Requirements

The UK MHRA’s regulation is currently based on the old European Directives: MDD/AIMDD/IVDD. This is because that was the legislation in place when the UK left the EU (“Brexit”).

Therefore, manufacturers would follow the process under the old MDD Article 12, with a few differences. The primary difference is that System/Procedure Pack Producers must appoint a UK Responsible Person (UKRP) and the UKRP will register the System/Procedure Pack with the MHRA.

For more information on the role of the UKRP and the UK registration process, please read: UK Steps to Market

NOTE: the MHRA is in the process of overhauling its regulatory system. As part of that, the requirements for Systems, Procedure Packs, and Kits will be modified.

Per the MHRA:

Switzerland Requirements

In general, the requirements align between Switzerland and the EU. This is because Switzerland has, for the most part, transposed the MDR and IVDR into its national legislation.

Therefore, obligations around Economic Operator (“Actor”) and device registration, as well as UDI, verification of mutual compatibility and the corresponding Statement, all apply for Systems/Procedure Packs.

However, there are a few notable differences:

IVD Kits are treated the same in Switzerland as they are in the EU, i.e., they are medical devices in their own right and the manufacturer must meet all the legal obligations as outlined in the Swiss In Vitro Diagnostic Ordinance (IvDO).

For more information on the role of the Swiss Authorized Representative and the registration process, please read: Switzerland Steps to Market