Regulatory guide to Procedure Packs, Systems, IVD Kits, and Configurable devices

If you package and sell sets containing medical devices or in-vitro diagnostic devices (IVDs) in EEA countries or Switzerland, you need to be familiar with the regulatory concepts of “Procedure Pack”, “System”, “Kit”, and “Configurable device”.

Key takeaways

• Companies who package and place on the market sets of CE-marked devices may be Procedure Pack / System Producers or even IVD manufacturers. Make sure you verify your role and understand the implications.
• “Convenience kit” is not a legal term. Such kits may correspond to a “Procedure Pack” or “System”, an “IVD kit”, or a medical device in its own right.
• The concepts of “Procedure Pack” and “System” have traditionally been misunderstood and inconsistently applied. Even if clarification was brought by the EU MDR; a new source of potential confusion has been introduced with the term “Configurable device”.

Contents

What are “Procedure Packs” and “Systems”?

When a company sells a CE-marked device combined with any of the below products, such combination corresponds to a Procedure Pack or a System, per Art. 22(1) of Regulation 2017/745 on medical devices (EU MDR):

• other CE-marked devices, and/or
• in-vitro diagnostic devices (IVDs), CE-marked under Regulation (EU) 2017/746 (i.e. IVDR), and/or
• other products which are in conformity with legislation that applies to those products, only if they are used within a medical procedure or their presence is otherwise justified.

Since there is no restriction as to what “other products” could be, these may be simple consumer goods (e.g. a case). However, if a product that is not a medical device is specifically intended by its manufacturer to be used with a given medical device (e.g., a protective case or a case specifically designed to carry a given device), it then corresponds to an “accessory for a medical device”, as defined in EU MDR Art. 2(2), and must be CE-marked.

Procedure Pack and System concepts are frequently misunderstood. Specifically:

• A Procedure Pack, per the definition in EU MDR Art. 2(10), is:

“a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose.”

These could be, for example: first aid kits, orthodontic kits, skin traction kits, or surgical instrument kits for implant placement.

Procedure Packs are meant to simplify the management of medical devices needed for a surgical or therapeutic procedure. They present advantages for the healthcare professionals in terms of preparation time, contamination prevention, and packaging waste. Frequently, they contain single-use devices and/or surgically reusable instruments.

• A System, per the definition in EU MDR Art. 2(11), is:

“a combination of products, either packaged together or not, which are intended to be interconnected or combined to achieve a specific medical purpose.”

Examples would be: X-ray equipment systems or CT scan systems, although these could also correspond to a configurable device. See “What is a “Configurable device”?”

A system that is fully packaged together would differ from a Procedure Pack in its purpose, which would be the interconnection for recurrent use instead of a single surgical or therapeutic procedure. Now, the regulatory requirements for Systems are virtually the same as for Procedure Packs.

Procedure Pack and System concepts are frequently misunderstood.

If a Procedure Pack or System encompasses a non-CE marked medical device, per EU MDR Article 22(4), the set of products is to be treated as a medical device in its own right, which needs to be CE-marked. Consequently, the entity responsible for placing such sets of products on the market endorses the obligations of a legal manufacturer. 

If a distributor or importer supplies a set of different products together, including CE marked devices, upon a customer’s request, such set of products is not a Procedure Pack or a System if the entire combination is neither “placed on the market” by that distributor/importer, nor intended by that distributor/importer to be used together for a specific medical purpose. The following examples are mentioned in guidance document MDCG 2018-3: 

• a distributor supplies, upon request of a client, in one shipment, sterile tweezers, a sterile needle and surgery gloves,
• multi-device surgical sets composed of individual devices delivered in trays for replenishment and sterilization for the request and for convenience of the healthcare provider and the healthcare system.

Is a “System” in standard IEC 60601-1 the same as a “System” in the EU MDR?

The confusion is very common because the terminology used in international standards is not necessarily aligned with the definitions in the EU MDR or IVDR.

Standard IEC 60601-1, on the general requirements for basic safety and essential performance of medical electrical equipment (ME), defines medical electrical systems as the “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.”

This concept of “System” is intended to encompass all the elements that would be connected together for a medical device that is powered by electricity (e.g. mains plug, power supply cord, power adapter) and, thus, need to be tested for electrical safety as a unit. 

From an EU MDR perspective, those elements are typically components of the electromedical device, even if they are detachable or interchangeable (e.g. in the case of different power adapters for different regions). However, the manufacturer may choose to consider them as “accessories”, per the definition in EU MDR Art. 2(2), in which case they would be viewed as separate devices that need CE-marking, and their combination together with the main electromedical device would become a “System” per EU MDR Art. 2(10).

Note that a different definition of “accessory” exists in IEC 60601-1.

The terminology used in international standards is not necessarily aligned with the definitions in the EU MDR or IVDR.

What about in-house medical device combinations?

The combination of CE-marked medical devices by a user or healthcare institution, where the combination is undertaken in accordance with the specifications provided by the corresponding device manufacturers and with the intended use of the products combined, does not constitute “placing on the market”. The resulting combination is neither a Procedure Pack nor a System.

Conversely, the combination of medical devices (including in-vitro diagnostic devices, IVDs) for which the respective manufacturers have not foreseen their interoperability and/or interconnection, and between which the performance characteristics may not be mutually compatible, constitutes manufacturing. In this case, the user or healthcare institution shall endorse full responsibility as manufacturer of a new, in-house medical device. These are regulated per EU MDR or IVDR Article 5(5), provided the resulting combination is not transferred to another legal entity.

Are drug-device combination products “Procedure Packs”?

A kit that includes a pharmaceutical and a medical device can fall under either medical device or pharmaceutical legislation. It depends on the intended purpose of the pharmaceutical (primary or ancillary) and the level of integration of both parts in the resulting combination product.

Co-packaging of a CE-marked medical device with a pharmaceutical (i.e. where the medical device does not form a single integral product with the pharmaceutical) would indeed correspond to a Procedure Pack, per EU MDR Art. 22.

In their reflection paper of December 2019, the European Federation of Pharmaceutical Industry and Associations (EFPIA) strongly advocated against considering co-packaged pharmaceuticals as the “other products” referred to in EU MDR Art. 22(1), arguing that the main purpose is to ensure compatibility between the co-packaged products and such compatibility is required already as part of the pharmaceutical Marketing Authorization Application. However, EU MDR Art. 22 aims at ensuring patient safety in all situations, also considering the fact that such co-packaging is not necessarily done by a pharmaceutical company.

Co-packaged products need to be distinguished from drug-device combination products that form a “single integral” product, as described in the second paragraph of EU MDR Art. 1(9). Examples include: a pre-filled (non-rechargeable) syringe, patches for transdermal hormone therapy. These are governed by pharmaceutical legislation (i.e. Directive 2001/83/EC or Regulation (EC) No 726/2004) and, thus, not subject to EU MDR Art. 22.

What is a “Configurable device”?

This concept can be easily missed as it appears only in Annex VI of the EU MDR, where the different options for assigning the Unique Device Identifier (UDI) to a medical device are described.

A configurable device is defined as: “a medical device that consists of several components, which can be assembled by the manufacturer in multiple configurations. Those individual components may be medical devices in themselves”.

The result is a number of possible configurations, each corresponding to a specific combination of items intended by the manufacturer to operate together as a device to achieve an intended purpose. The manufacturer may modify, adjust or customize the combination of items to meet specific needs.

Examples of “Configurable device” indicated in EU MDR Annex VI, Part C, section 1, along with the definition include: 

• computed tomography (CT) systems, 
• ultrasound systems, 
• anesthesia systems, 
• physiological monitoring systems, and 
• radiology information systems (RIS). 

To avoid potential confusion between a “System” and a “Configurable device”, it is important to bear in mind that the latter concept is only introduced in the EU MDR for UDI purposes. In a configurable device setting, all the potential items that would make it into the various possible configurations are considered together and the UDI is assigned only at the “Configurable device” level, provided the individual items are not separately sold. More importantly, the concept of “Configurable device” includes the fact that the components are “assembled by the manufacturer” and, as such, the configuration leaves production as a unit. For example, an anesthesia system “configuration” may combine different ventilators, breathing circuits, and vaporizers. Whereas in a “System”, its different constituents can reach the market separately and even come from different manufacturers.

What is an IVD “Kit”?

A Kit, per Art. 2(11) of Regulation (EU) No. 2017/746 on in-vitro diagnostic devices (IVDR), is:

“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.”

In order to differentiate an IVD Kit from a Procedure Pack that includes IVDs, the main intended purpose of the kit would be the decisive element.

“Kits” are included in the definition of IVDs. As such, an IVD Kit needs to be CE-marked under the IVDR and the entity placing the IVD Kit on the market becomes an IVD manufacturer.

For example:

• A kit for isolation and purification of nucleic acids from human specimens that contains various reagents and solutions, is in itself a Class A device under IVDR classification rule 5. 
• A self-test kit for the detection of SARS-CoV-2 that contains a swab for specimen sampling, a reagent and the antigen rapid test, is in itself a Class D device under the IVDR classification rule 1.

The components in an IVD Kit might include non-IVD medical devices. Also, some components may correspond to “accessories for IVDs”, as defined in IVDR Art. 2(2), if they specifically enable the IVDs to be used in accordance with its/their intended purposes.

In order to differentiate an IVD Kit from a Procedure Pack that includes IVDs, the main intended purpose of the kit would be the decisive element. 

According to chapter 1.6 of the old MEDDEV 2.14/1 rev 2 on borderline aspects between IVDs and non-IVD medical devices (no analogous guidance under the EU IVDR is available in the new Manual on Borderline and Classification): “the qualification either as a ‘procedure pack’, according to MDD or as a ‘kit’ according to IVDD should be based on the principal intended purpose of the whole product combination”. This differentiation may be subject to different interpretations across stakeholders and, in case of doubt, companies that add IVDs to Procedure Packs should consult with their concerned competent authority.

Who is the Procedure Pack and System Producer and what are its duties?

The Procedure Pack (PP) or System “Producer” is any natural or legal person who combines CE-marked devices with other products (incl. other CE-marked devices or IVDs). The term “Producer” was coined in guidance document MDCG 2018-3 on the rules for assigning a Unique Device Identifier (UDI) to PP/Systems.

Under the EU MDR, the PP/System Producer must:

• Issue the Procedure Pack or System Statement required under EU MDR Art. 22(1) and maintain evidence of compliance. See “What is a Procedure Pack or System Statement?“
• Assign the Basic-UDI and UDI-DI to the Procedure Pack or System, per EU MDR Annex VI, Part C 6.3 and 3.7, in consideration of guidance document MDCG 2018-3.
• Register itself in EUDAMED as PP/System Producer and obtain a Single Registration Number (SRN) applicable to this role. 
• Once the UDI module becomes operational, register the Procedure Pack or System in EUDAMED, per EU MDR Art. 29(2) and MDCG 2018-3. In the meantime, national requirements on the registration with local competent authorities apply instead.
• Specific labelling, in consideration of the minimum information required in EU MDR Art. 22(5), i.e.:
  • PP/System name.
  • Name and address of the PP/System Producer.
  • List of the PP/System components (either on the label or in the accompanying documents). A Procedure Pack or System shall never bear an additional CE-mark itself but, when listing any medical device or IVD components their corresponding CE-marking should be unequivocally indicated.
  • PP/System lot number.
  • UDI-PI for the PP/System.
  • Expiration date, based on the shortest dated component within the PP/System, if applicable.
  • For a PP/System that contains sterile and non-sterile components, information on the packaging that maintains the sterile condition of the sterile device.

The PP/System Producer does not need to set up a Quality Management System (QMS) for medical devices like a manufacturer does. Still, some QMS procedures are necessary, particularly to ensure the correct combination of the components (e.g. verification of compatibility in accordance with the specifications or instructions from the respective manufacturers).

Further repackaging or relabeling of any CE-marked devices within a Procedure Pack issued under the EU MDR, for example by providing translations to the instructions for use or by removing the secondary packaging of a CE-marked device, could entail additional requirements for the PP Producer. Two options are possible:

• When such activities are conducted under an agreement with the manufacturer of the original device, the PP Producer remains a subcontractor and the activities fall under the control of the device manufacturer and EU MDR Art. 16(2), (3) and (4) do not apply. This was clarified in guidance document MDCG 2021-26 on relabeling and repackaging.
• When the PP Producer undertakes relabeling or repackaging activities by itself, per EU MDR Art. 16(3) and (4), the PP Producer must: 
  • Indicate the activities undertaken on the PP labeling. Translation and repackaging symbols have been created for this purpose and are integrated in standard EN ISO 15223-1. 
  • Fulfill QMS requirements for the relabeling/repackaging activities undertaken. This entails obtaining a certificate from a Notified Body. Guidance document MDCG 2021-23 provides details on the expected QMS and the certification process.
  • Notify the placing on the market of the relabeled/repackaged device to the manufacturer and competent authorities of the countries affected, at least 28 days before.

For PP/System Producers based outside of the EEA, an EU Authorised Representative is not required. However, any non-EEA manufacturers of the CE-marked devices within the PP/System that can be sold separately should have appointed an EU Authorised Representative covering those devices. Note that the situation in Switzerland is different.

Last, Vigilance and Post-market Surveillance (PMS) requirements for PP/Systems in the EEA are yet to be clarified as part of a forthcoming MDCG guidance document. As a basic principle, there should be communication between the PP/System Producer and the manufacturers of the CE-marked devices on any customer complaints or safety issues revealed by the use of the PP/System.

Can Procedure Packs and Systems benefit from “legacy” status under the EU MDR?

Yes.

This is not contemplated in the transitional provisions of EU MDR Art. 120 but was clarified by guidance document MDCG 2021-25 on legacy devices under the EU MDR, which considers that: “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.”

In brief, as long as all the medical devices within a Procedure Pack or System are still CE-marked under the former Directives, the resulting Procedure Pack or System remains subject to Article 12 of Directive 93/42/EEC on medical devices (MDD), which was less demanding.

Procedure Packs and Systems can benefit from “legacy” status under the EU MDR.

In addition, MDCG 2021-25 also indicates that EU MDR Art. 16(3) and (4) relative to the duties of entities relabeling or repackaging devices, which are described in the previous section, do not apply to legacy devices.

For more information on “legacy” devices, read our blog article “Legacy” medical devices and IVDs under EU legislation.

What is a Procedure Pack or System Statement?

In accordance to EU MDR Art. 22(2), the Procedure Pack or System Statement should indicate that the Producer has:

• Verified the mutual compatibility of the medical devices and other products, in accordance with the respective manufacturers’ instructions and carried out the assembly activities in accordance with those instructions.
• Packaged the Procedure Pack or, if applicable, the System and supplied relevant information to users incorporating the instructions for use provided by the respective manufacturers of medical devices or other products that are put together.
• Subject the activity of combining devices and, if applicable, other products as a Procedure Pack or System to appropriate methods of internal monitoring, verification and validation.

A template statement can be simply built by copying the above points that apply to the Procedure Pack or System. Evidence of compliance should be maintained by the PP/System Producer.

For “legacy” Procedure Packs or System, the statement shall follow Article 12(2) of the MDD, which requires very similar content with the exception that the methods applied to the combination activities under the MDD only need to cover internal control and inspection.

The statement shall be kept at the disposal of the competent authorities, after the Procedure Pack or System has been put together, for the longest period that is applicable under EU MDR Art. 10(8) to the medical devices therein.

What requirements apply to the sterilization of Procedure Packs?

Any company who sterilizes Procedure Packs or Systems shall obtain certification for the sterilization activities from a Notified Body. The intervention of the Notified Body is however limited to the aspects of the procedure relating to the obtaining of sterility until the sterile package is opened or damaged. 

Notified Body certification is required under EU MDR Art. 22(3), and must follow one of the procedures in EU MDR Annex IX or Part A of Annex XI. This process should apply also in the case of companies who would sterilize PP/Systems containing only “legacy” devices after 26-May-2021 (date of application of the EU MDR), even if an equivalent requirement existed under MDD Art. 12(3), since Notified Bodies cannot issue certificates under the MDD anymore.

The company undertaking the sterilization of Procedure Packs or Systems shall draw up a declaration stating that sterilization has been carried out in accordance with the manufacturer’s instructions. This might get particularly complex for Procedure Packs that include a pharmaceutical and a CE-marked medical device, where the instructions from the corresponding manufacturers are not aligned.

What additional or different requirements apply in Switzerland?

The Swiss Medical Device Ordinance (SR 812.213, MedDO) and In-vitro Diagnostic Device Ordinance (SR 812.219, IvDO) basically follow the EU MDR and IVDR, respectively.

In our consultancy role, we see an increasing interest from Swissmedic in companies offering Procedure Packs and IVD Kits for self-testing in Switzerland.

However, two main aspects are different in Switzerland regarding Procedure Packs and Systems:

• Per MedDO Art. 51 §5, a Swiss Authorised Representative (CH-REP) is required for companies who are not based in Switzerland and assemble Procedure Packs or Systems under EU MDR Art. 22. After 31st July 2023, the particulars of the CH-REP shall be indicated on the label.
• PP/System Producers have Vigilance duties and must report serious incidents occurring in Switzerland and Field Safety Corrective Actions undertaken in Switzerland to the Swiss competent authority, Swissmedic, per MedDO Art. 66 §1. For foreign PP/System Producers, the CH-REP must ensure that reporting obligations are fulfilled.

In our consultancy role, we see an increasing interest from Swissmedic in companies offering Procedure Packs and IVD Kits for self-testing in Switzerland. It is therefore recommended to gain an in-depth understanding of the implications of selling sets of medical devices with or without IVDs in this country.

How Decomplix can help

Decomplix offers consultancy services in all regulatory and quality assurance matters relative to medical devices. We have in-house experts and a network of first-in-class partners.

We can support your company in fulfilling all the requirements for Procedure Packs, Systems or IVD Kits, and ensure compliance in the most efficient manner. If you wish to discuss your needs with us, please contact us for a non-binding CE marking quote.

In addition, we offer Swiss Authorised Representative services under both the MedDO and the IvDO, and already represent numerous foreign manufacturers. Our services include instructions and checklists for your understanding of the applicable requirements. If you are interested in Decomplix’ Swiss Authorised Representative services, please contact us via this form.

Further reading

• How to obtain a CE mark for a medical device
• Is My Product a Medical Device? Medical Device Definition under MDR 
• The intended purpose – or, what does your medical device do?
• “Legacy” medical devices and IVDs under EU legislation – Decomplix 
• Swiss authorised representatives for medical device manufacturers