Requirements for medical device and IVD distributors in the EU

Medical device and in-vitro diagnostic (IVD) distributors play an essential compliance role in the supply chain. The duties are well described in the EU MDR and IVDR.
If you are uncertain on whether you are viewed as a distributor under the EU MDR or IVDR, or on the regulatory implications, this article will help you.

Replaces the previous version of 23.03.2022

Key Takeaways

• Any entity or individual making available devices on the market may be viewed as a distributor under the EU MDR or IVDR. This applies equally to physical devices and medical device software.
• Medical device and IVD distributors endorse important duties relative to device conformity verification, device traceability, cooperation with economic operators and competent authorities, and Vigilance support in addition to good distribution practices.
• Distributors who wish to modify a medical device or IVD (incl. translating instructions for use), should be aware that only certain, very limited modifications are possible without becoming the legal manufacturer.

Content:

What has changed in the EU MDR and IVDR?

EU regulations 2017/745 on medical devices (EU MDR) and 2017/746 on in-vitro diagnostic devices (IVDR) have helped clarify the expectations of the different actors in the supply chain, what is known as “economic operators”. Indeed, they integrate those requirements that used to be described as part of a separate legislative act (Dec. No. 768/2008), which was then transposed into the national legislation of the concerned countries.

Distributors who think that the EU MDR and IVDR have introduced new, cumbersome requirements should realize that they had missed the rules of making available devices on the market under the former Directives described in Dec. No. 768/2008, and need to catch up with the gaps in their processes.

Who is a distributor? 

According to the EU MDR and IVDR, the distributor is: 

“any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service”.
[EU MDR Art. 2(34) / IVDR Art. 2(27)]

This definition applies equally to physical devices and to medical device software. Distributors of medical device software can be companies that make available the software to end users from their platforms.

“Making available” devices on the market corresponds to a commercial activity irrespective of whether it is in return of payment or free of charge. And it implies a transfer of ownership, possession or any other property right, which does not necessarily require the physical handover of the product. Commercial activity excludes investigational devices and IVDs for performance studies.

This means that any entity (including pharmacies, opticians, or other retailers) and any individual who further supplies devices received from an entity within the “Union market” is considered a distributor.

The “Union market” encompasses the current 27 EU Member States incl. some overseas territories where EU legislation applies (e.g. Azores, Martinique), 3 EFTA countries (namely: Iceland, Liechtenstein, and Norway), Northern Ireland, and Turkey. As to European microstates (i.e. Andorra, Monaco, and San Marino), they have a particular status that depends on the bilateral agreements in place. Chapter 2.9 of the Blue Guide, which is a non-binding document published by the EU to clarify product rules relative to CE-marking in general, provides a detailed explanation of the geographic scope of the Union market.

It is important to remember that Switzerland and the United Kingdom (with the exception of Northern Ireland) are not part of the Union market, and are considered third countries. Read more about Switzerland in our blog article on Swiss authorised representatives for medical device manufacturers.

The distributor role also applies to companies who assemble Procedure Packs or Systems that contain individual devices coming from other entities based in the Union market. As such, they endorse a dual economic operator role: as distributor of the individual devices and as producer of the Procedure Pack or System.

Can third-party logistics providers (3PL) be distributors?

Third-party logistics providers (3PL) typically offer transportation and short-term in transit storage of devices, without ownership, possession or any other right over those devices. Therefore, they do not “make available” devices on the market and do not correspond to distributors under the EU MDR/IVDR.

The services from a 3PL may even correspond to the concept of “fulfilment service provider”, i.e. an entity or person who offers, in the course of commercial activity, at least two of the following services: warehousing, packaging, addressing and dispatching, without having ownership of the products involved. Contrary to the EU MDR and IVDR, fulfilment service providers are considered a type of “economic operator” in Reg. (EU) 2019/1020 on market surveillance and are described in detail in chapter 3.5 of the Blue Guide.

3PL do not correspond to distributors under the EU MDR/IVDR, as long as they do not “make available” devices on the market.

Guidance document MDCG 2021-27 relative to distributors and importers under the EU MDR and IVDR clarifies that fulfilment service providers do not correspond to medical device or IVD distributors unless they carry out activities that meet the definition of making available devices on the market, i.e. when there is a transfer of ownership, possession or other right over the devices.

In brief, the determining factor to be viewed as a distributor under the EU MDR or IVDR is not the fact that an entity warehouses, dispatches and ships medical devices or IVDs within the Union market, but the fact that it purchases the device from another actor in the distribution chain and further sells it, i.e. the transfer of ownership.

Can a distributor simultaneously be the importer for a given device?

Medical device or IVD distributor and importer are separate regulatory roles. These roles should not be mistaken with the (business) concept of distributing goods, in the sense of shipping or selling. Whereas both importers and distributors can and do ship or sell devices, these activities are not the determining factor to becoming an importer or a distributor under the EU MDR or IVDR. Guidance document MDCG 2021-27 includes numerous examples that illustrate these roles. In brief:

• The distributor only “makes available” devices on the Union market. Making available means that distributors just supply the devices within the Union territory to other distributors or retailers, or a healthcare facility, or the end user. 
• Instead, the importer “places” devices on the Union market. Placing on the market means that importers bring devices from outside the Union territory (either from the foreign manufacturer or from a foreign distributor) and further supply them within the Union territory to a distributor or healthcare facility or the end user. Read more about device importers in our specific blog for Swiss device importers.

A same entity may have activities as distributor for devices from economic operators located within the Union market coupled with activities as importer for devices from economic operators located in third countries, i.e. outside the Union. 

Conversely, it is not possible for the same entity to simultaneously play the distributor and importer roles for the same device. A given device is supplied to that entity either from within the Union market (thus, turning the entity into a distributor) or from outside the Union market (thus, turning the entity into an importer).

Does the distributor role apply to devices in transit?

Devices in transit within the Union territory for subsequent exportation outside the Union are not intended to be placed or made available on the Union market. As such, the entities involved in such temporary transit are neither distributors nor importers within the meaning of the EU MDR or IVDR. Moreover, such devices are not required to comply with EU MDR or IVDR either.

This would be the case, for example, of an EU-based distributor who would bring a device from a third country (e.g. Switzerland) to its German warehouse for subsequent exportation outside the Union (e.g. Serbia).

However, special customs clearance conditions for temporary admission apply to goods in transit or placed in free zones and free warehouses, and entities engaging in such activities should become familiar with the administrative procedures.

Which duties behove distributors, according to the EU MDR and IVDR?

Basic duties of distributors are mostly outlined in Article 14 of the EU MDR and IVDR.

Contrary to other economic operators, despite their responsibilities under the EU MDR and IVDR, distributors do not need to register as actors in EUDAMED. However, they may need to register with their competent authority. In some EEA countries, distributors are subject to some type of national registration.

If the distributor engages in relabelling or repackaging activities, more complex requirements apply, up to the point where a distributor may be viewed as the legal manufacturer. For details, see When does a distributor endorse legal manufacturer’s obligations?

The basic duties of distributors can be clustered into the following 5 groups, which are further described below:

1. Pre-market verification of compliance
2. Traceability
3. Good distribution practices (GDP)
4. Vigilance support
5. Cooperation/communication with competent authorities and economic operators

Pre-market verification of compliance:

Before making a device (including medical device software) available on the market, distributors must verify at a minimum that:

• the device is CE-marked,
• the manufacturer has drawn up a valid EU declaration of conformity,
• the device is accompanied by the instructions for use and labels, as applicable, and the labelling is provided in the mandatory languages of the envisaged distribution countries (for more information, see our blog article on labelling language requirements),
• the Unique Device Identifier (UDI) required under the EU MDR and IVDR has been assigned by the manufacturer, and
• for imported devices only, the importer has indicated its particulars on the devices or in the respective instructions for use.

The verification may be conducted by a sampling method that must be representative of the devices supplied, except for the importer’s particulars, which must be verified for each device.

Traceability:

Distributors must help maintain an appropriate level of traceability in the device supply chain. 

• Under both the EU MDR and IVDR, distributors must be able to identify any customer (i.e. economic operator or healthcare institution/professional) to whom they have directly supplied a device and any supplier (i.e. economic operator) from whom they have been supplied a device. 
• Also, per EU MDR Art. 27 (8), distributors must maintain a list of UDIs for any class III implantable devices they have received and/or further supplied. The EU Commission may issue implementing acts listing additional devices to which the requirement to maintain UDI traceability applies. 

Good Distribution Practices (GDP):

Distributors shall ensure that, while the device is under their responsibility, storage or transport conditions comply with the conditions set by the manufacturer.

This requirement entails the need for appropriate premises and staff, as well as internal procedures describing how to ensure that the manufacturer’s storage and transport instructions are duly considered.

Distributors must keep a register of complaints, non-conforming devices, recalls and withdrawals.

Vigilance support:

“Vigilance” refers to the mandatory reporting to national competent authorities of certain device-related issues that might be revealed in the post-market phase. Vigilance duties are part of the manufacturer’s responsibilities but all actors in the supply chain must also cooperate.

Specifically, distributors must keep a register of complaints, non-conforming devices, recalls and withdrawals. They are obliged to keep the relevant economic operators informed of such monitoring, and to provide them with any available information at their request. 

If distributors receive complaints or incident reports from the field regarding a device that they make available on the market, they are obliged to immediately forward the information to the manufacturer (and, in the case of imported devices, the importer and the manufacturer’s EU Authorised Representative).

Communication & Cooperation:

If distributors have reason to believe that a device does not fulfil the EU MDR or IVDR requirements, they must inform the manufacturer and the importer, as well as, for manufacturers located outside of the Union, the manufacturer’s EU Authorised Representative. 

Furthermore, distributors are obliged to immediately inform the national competent authority if they have reason to believe that a device was falsified and/or presents a serious risk to patients’ health. It is therefore not enough to freeze the distribution of the faulty device; the notification to the competent authority is compulsory.

Upon request by a competent authority, distributors must be in a position to provide or have the manufacturer provide all the information and documentation necessary to demonstrate the conformity of a device. Distributors may also be requested by a competent authority to provide free samples of a device or, where that is impracticable, grant access to the device. Throughout their activities, distributors shall cooperate with competent authorities, at their request, on any action taken to eliminate the risks posed by devices that they have made available on the market.

When does a distributor endorse legal manufacturer’s obligations?

Article 16(1) in EU MDR and IVDR specifies that a distributor assumes the obligations of the manufacturer as a result of any of the following changes:

• The distributor makes available on the market under its own name, registered trade name or registered trademark, except if the distributor and the manufacturer have entered an agreement whereby the manufacturer is identified as such on the label and remains responsible for the manufacturer duties under the EU MDR or IVDR.
  This scenario would correspond to a “private label” agreement.
• The distributor changes the intended purpose of a device already placed on the market or put into service.
• The distributor modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected. However, this does not apply in case of certain relabelling or repackaging activities, as explained below.

EU MDR/IVDR Art. 16(2), (3), and (4) cover the requirements for relabelling (including the provision of translations) and repackaging by a distributor (or other entity who is not the manufacturer) and a bespoke guidance document, MDCG 2021-26, provides detailed questions and answers on the different aspects of these activities.

In brief, relabelling/repackaging may be undertaken by the distributor on behalf of the manufacturer or on its own account.

On behalf of the manufacturer

Section 2 of MDCG 2021-26 indicates that: 

“Article 16(2), (3) and (4) of the Regulations do not apply to operators subcontracted by the manufacturer (that may also qualify as importers or distributors), who also carry out relabelling and/or repackaging activities on behalf and under the control of the manufacturer.”

In such a case, a specific quality agreement for the subcontracted activities is expected to be in place between the manufacturer and the distributor.

On its own account

Relabelling/repackaging must then be carried out within the frame of EU MDR/IVDR Article 16(2), which is very restrictive. It allows only to provide device information (including translations) and/or to change the outer packaging of the device to the extent “necessary” to market that device in the concerned country, and without affecting the original condition of the device. There is no definition of what “necessary” means, but MDCG 2021-26 illustrates it with the example of supplying in a new package a number of devices different from the number of devices supplied in the original packaging by the manufacturer.

In addition, per Article 16 (3) & (4) of the EU MDR/IVDR, the distributor must:

• Indicate on the device, its packaging or an accompanying document, the activity carried out (e.g. translation),
• Have a quality management system that includes procedures to ensure accurate and up-to-date translations, and that relabelling/repackaging activities are carried out under appropriate conditions,
• Obtain a certificate from a Notified Body attesting that the quality management system complies with the requirements, and
• Inform the concerned competent authority and the manufacturer of such activities at least 28 days prior to making the relabelled/repackaged device available on the market.

It is important to highlight that Article 16(3) and (4) do not apply to “legacy” devices but such relabelling or repackaging was not contemplated under the former Directives either.

When the relabelling/repackaging is undertaken on the distributor’s own account to make the devices available under its trade name (what is commonly known as “private label”), this corresponds to the case described in Article 16(1)(a), where an agreement with the manufacturer would be needed to prevent the distributor from endorsing the manufacturer’s obligations.

Procedure Pack or System Producers are a particular case, as they relabel and repackage medical devices that might be CE-marked by third parties. These activities are however covered by EU MDR Article 22. For more details, read our blog article on Procedure Packs and Systems.

Do distributors need a Quality Management System (QMS)? 

EU MDR/IVDR Article 14 does not include any legal obligation for distributors to set up and maintain a QMS. Neither does the Blue Guide mention it.

Nevertheless, the processes that all distributors must have in place in order to fulfil their duties under the EU MDR/IVDR shall be thoroughly documented. The systematic procedures of a QMS allow distributors to ensure that only devices that meet the conformity requirements are distributed and that non-compliant, falsified or unsuitable medical devices are identified, prevented from reaching the market, and that traceability is maintained.

However, the absence of any legal obligation to introduce a QMS only applies to distributors for as long as they do not engage in relabelling/repackaging activities, as described in the previous chapter.

According to EU MDR/IVDR Article 16(3), the QMS that distributors shall implement for relabelling/repackaging activities must ensure that:

• any translation of information is up to date, which entails establishing mechanisms for the manufacturer to notify changes to the distributor,
• the changes made to the packaging do not have any impact on the original condition of the device, and 
• the new packaging is of adequate quality. 

EU MDR/IVDR does not include any legal obligation for distributors to set up and maintain a QMS.

Guidance document MDCG 2021-23 describes the QMS certification by Notified Bodies that is required according to EU MDR/IVDR Art. 16(4). This document lists the areas that the distributor’s QMS needs to cover in order to meet the requirements of EU MDR/IVDR Article 16. For example, this includes the clear allocation of responsibility within the organisation, processes for taking corrective actions, processes to ensure traceability of devices, as well as various control mechanisms.

Per MDCG 2021-23, the QMS should also include contractual agreements to ensure conformity. This means that contracts with economic operators, from which the distributors purchase the devices, should ensure conformity and that distributors are informed in time about any corrective actions required to respond to safety issues or in order to achieve conformity of the device. In this context, the guidance even suggests that the contract between distributors and Notified Bodies should include the possibility for on-site audits at the premises of distributors or subcontractors.

Is the distributor role different in Switzerland? 

No. The only differences stem from the fact that Switzerland is now considered a third country, thus not part of the Union market.

Switzerland has a different regulatory basis (MedDO and IvDO), although it is largely based on the EU MDR and IVDR, and a Swiss Authorized Representative is needed for any manufacturer based outside of Switzerland.

You can find more information on Swiss-specific requirements in our blog articles about Swiss importers and Swiss Authorised Representatives.

How Decomplix can help

Decomplix provides regulatory and quality assurance consultancy services in all matters relative to medical devices and IVDs. 

We have extensive experience in compliance issues within device supply chains and can support your company identify an appropriate solution for your quality management system, as well as help you navigate distributor’s requirements and ensure compliance in the most efficient manner. Here you can find more on Swiss Compliance for Importing Medical Devices

In addition, we offer Swiss Authorised Representative services under both the Swiss MedDO and the IvDO and already represent numerous foreign manufacturers. The services include a mandate contract, detailed step-by-step instructions and checklists for your understanding of the applicable requirements.

If you have any questions regarding the role of the distributor under the EU MDR or need help establishing a QMS, our team of experts is at your disposal. Please do not hesitate to contact us.

Further reading

• Swiss medical device importers – regulatory requirements
• “Legacy” medical devices and IVDs under EU legislation
• EU MDR language requirements — what manufacturers and distributors need to know
• Regulatory guide to Procedure Packs, Systems, IVD Kits, and Configurable devices
• Annex XVI and EU MDR – Guide to regulation of products without intended medical purpose
• Certification of a Quality Management System according to ISO 13485