The EU Medical Device Regulation 2017/745 (MDR) and EU IVD Regulation 2017/746 (IVDR) have both shaken up the way in which devices are regulated within the Union. Amongst the new requirements and obligations being imposed on economic operators, perhaps one of the most impactful are those found in Article 13 of these Regulations, which lay out the obligations and requirements of importers.
To understand the obligations of medical device importers, one must first start at the definition of an importer which, in itself, can be perplexing. Article 2(33) of the MDR defines the importer as “any natural or legal person established within the Union that places a device from a third country on the Union market”. The key takeaway here is placing on the market, which itself is defined in Article 2(28) as “the first making available of a device, other than an investigational device, on the Union market”. If this doesn’t help clarify the situation, Section 2.3 of the “Blue Guide” is dedicated specifically to this topic.
The concept of placing on the market involves either the manufacturer or the importer supplying a product to a distributor or end-user, for the first time. Subsequent operations are defined as “making available” e.g. distributor to distributor, or distributor to an end-user. Therefore, if your organisation is receiving medical devices from manufacturers based outside of the EU, and are then passing this on to a distributor, then you qualify as an importer. In cases when the importer goes on to sell the product to the end user, then that organisation shall also take on the obligations of the distributor.
Due to the obligations spelt out in the EU Regulations, importers join the chain of liability as one of the entities which must ensure that the product being placed on the EU market is compliant with the regulations. Therefore, importers must ensure that they understand these new obligations and implement the appropriate processes to ensure continued compliance.
Importer Obligations #
The ‘General Obligations of Importers’ are clearly laid out in Article 13 of the EU Regulations. This section starts off with perhaps the most important of all:
“Importers shall place on the Union market only devices that are in conformity with this Regulation.”
Whilst this may seem obvious, it is imperative that importers verify that the devices are in conformity with the Regulation. The extent of this verification may differ from one company to the next, however, the importer must do their utmost to ensure that what they are placing on the market is actually compliant.
Verifications [Article 13(2)(4)] #
Article 13(2) requires that importers verify that:
(a) the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;EU Regulations, Article 13(2)
(b) a manufacturer is identified and that an authorised representative in accordance with Article 11 has been designated by the manufacturer;
(c) the device is labelled in accordance with this Regulation and accompanied by the required instructions for use;
(d) where applicable, a UDI has been assigned by the manufacturer in accordance with Article 27.
The extent to which an importer conducts these verifications may vary depending on factors such as device classification and the existing relationship with the manufacturer. However, we would suggest that the Declaration of Conformity is reviewed in its entirety against the requirements of Annex IV of the Regulations. Furthermore, ensure that you hold the CE Certificate for that device, when applicable.
A review of the device’s labelling, packaging, and instructions for use (IFU) will be a critical element of compliance. Article 13 asks for importers to ensure the device has been CE marked; we would add that they should ensure that the CE mark has also been affixed appropriately. Reviewing the labels, packaging, and IFU against the requirements of the Regulations will require a good understanding of the General Safety and Performance Requirements in Annex I.
Furthermore, the importer must verify that the manufacturer has appropriately assigned a Unique Device Identifier (UDI) to each device. The transitional provisions for the placement of the UDI are detailed in Article 123 of the MDR and Article 113 of the IVDR. In addition to this, Article 13 also requires that importers ensure that the UDI-DI has been registered on Eudamed, although transitional provisions also apply with respect to this requirement. When allowed through the Eudamed system, importers are also requested to add their details against the registration, as implied within Article 31.
It is possible for the importer to request the above documentation before actually receiving the device itself. Once received, the physical checks can then take place.
In the event that an importer has reason to believe that the device does not comply with the Regulations, then they should quarantine them and inform the manufacturer and their authorised representative of the decision. If it is believed to pose a serious risk, or in the case of a falsified device, the importer shall also inform the competent authority in the member state in which the importer is based.
Importer Identification [Article 13(3)] #
The EU Regulations introduced another requirement which will require importers of medical devices to indicate on the device, its packaging, or in an accompanying document the following details:
- Importer name, registered trade name or trademark.
- Registered place of business.
- Address at which they may be contacted.
If the above details are provided as additional labelling, then this should not cover any information on the label provided by the manufacturer. Although not specifically indicated within the Regulations, it will also be acceptable to have the manufacturer include these details on the packaging, however, the importer should still verify that they have been appropriately identified.
Storage and Transport [Article 13(5)] #
Whilst under their responsibility, the importer shall ensure that the medical devices are stored and/or transported as agreed upon with the manufacturer and in a way which does not jeopardise its compliance with the general safety and performance requirements as set out in Annex I.
Vigilance [Article 13(6)(7)(8)(10)] #
The importer is required to keep a register of complaints, nonconforming devices, recalls, withdrawals and other related events, and shall provide the manufacturer, authorised representative, and distributors with any necessary information requested by them for the investigation of complaints.
Upon receipt of such complaints or reports from healthcare professionals, patients, or others, related to incidents with a device they have placed on the market, the importer shall immediately pass on the information to the manufacturer and authorised representative. Furthermore, importers shall cooperate with the relevant Competent Authorities at their request to take any action to eliminate or mitigate risks posed by the devices which have been placed on the market. A request made by the Competent Authority for samples of the device must be provided free of charge, or when applicable, access granted to the device in question.
In the event that the importer considers that a device they have placed on the market is not compliant with the Regulation, then they are required to immediately inform the manufacturer and authorised representative.
Furthermore, they will be required to cooperate and help coordinate any corrective action to bring that device back into conformity. In the event that the device may cause a high risk, the competent authorities in the Member State where they have placed the device on the market shall be notified immediately, as well as the relevant Notified Body.
It will be important for importers to have a robust procedure for tackling vigilance-related issues and have the appropriate staff in place to identify such issues and implement the procedure accordingly.
Document / Record Retention [Article 13(9)] #
Importers will need to ensure that all required documents and records are kept for at least 10 years after the last device covered by the EU Declaration of Conformity has been placed on the market. The requirement goes up to 15 years for implantable medical devices.
Within their quality management system, one would expect the importer to have a robust document/record control procedure and policy in place to ensure that they meet this requirement. The Regulations specifically indicate that a copy of the relevant Declaration of Conformity and certificates (if applicable), as well as their amendments and supplements, shall be kept. It is recommended that sufficient security is put in place to ensure that these documents remain secure and preserved appropriately throughout the retention period.
The EU Regulations also require that importers are registered on the Eudamed database. In doing so, and after the relevant Competent Authority has reviewed the registration, the importer will be provided with a Single Registration Number (SRN). Although not a mandatory requirement until Eudamed becomes fully functional, we suggest that all importers acquire the SRN. The information entered on Eudamed should be reviewed 1 year after original registration, and then reviewed every second year thereafter, to ensure that the registration is accurate. In the event of a change in any of the information on Eudamed relating to that importer, the Regulations require that the profile be updated within a week of that change being made.
Quality Agreements #
It is strongly recommended that a quality agreement/contract is drawn up between the legal manufacturer and its importer into the EU, as part of their quality management system. This should clearly indicate which activities each party shall be carrying out, as well as clearly identify each organisation’s responsibilities and obligations. In particular, the agreement is a document that conformity assessment bodies will be looking for and will audit against the requirements of the EU Regulations.
Are your activities qualifying you as the legal manufacturer? #
Importers and distributors of medical devices (and other natural or legal persons) should be aware that certain actions performed on the medical device may require them to take on the obligations of manufacturers, as detailed in Article 16 of the EU MDR and EU IVDR. This article indicates that an organisation performing any of the following “shall assume the obligations incumbent on manufacturers”:
(a) makes available on the market a device under its name, registered trade name or registered trade mark, except in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in this Regulation;EU Regulations, Article 16(1)
(b) changes the intended purpose of a device already placed on the market or put into service;
(c) 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.
For organisations repackaging or relabelling the device in their own name, an agreement with the legal manufacturer must be in place which allows you to do so. Furthermore, the label must clearly indicate the legal manufacturer on it. Furthermore, any additional information provided on the packaging must not interfere with that which has already been provided by the legal manufacturer. In many cases, the organisation selling the product enters into an agreement with the legal manufacturer which enables the latter to print the artwork showing the former’s trade name.
Changing the intended purpose automatically means that that organisation shall take on the obligations of the legal manufacturer. A simple example of this would be when a device originally intended for use in the mouth is sold by a distributor for use throughout the gastrointestinal tract. Importers and distributors must ensure that the device they are placing on the market continues to be used in accordance with the legal manufacturer’s original intended purpose. A change in indication or claim could make such organisations the legal manufacturer.
Furthermore, unless intended to be modified or assembled for a particular individual, if an importer, distributor, or other person modifies a device such that it no longer complies with the applicable requirements of the Regulation, then that organisation shall assume the obligations incumbent on manufacturers. Article 16(2) provides consideration to those actions which will not be considered a modification of the device:
(a) provision, including translation, of the information supplied by the manufacturer, in accordance with Section 23 of Annex I, relating to a device already placed on the market and of further information which is necessary in order to market the device in the relevant Member State;EU Regulations, Article 16(2)
(b) changes to the outer packaging of a device already placed on the market, including a change of pack size, if the repackaging is necessary in order to market the device in the relevant Member State and if it is carried out in such conditions that the original condition of the device cannot be affected by it. In the case of devices placed on the market in sterile condition, it shall be presumed that the original condition of the device is adversely affected if the packaging that is necessary for maintaining the sterile condition is opened, damaged or otherwise negatively affected by the repackaging.
Although the above points are quite clear in what does not constitute a modification of the device, we would suggest that any importer or distributor performing these activities changes ensures that they have an agreement or understanding with the legal manufacturer in order to make these amendments. The Regulations require that a distributor or importer who carries out the above of the above two activities must indicate on the device or (when not practicable) on the packaging or document accompanying the device the activity which has been carried out, and by whom.
Distributors or importers taking on translation activities shall have within their quality management system a procedure in place which governs how translation shall be performed and remain accurate and up to date. They shall also ensure that the translation is accurate and preserves the information provided by the legal manufacturer.
An importer or distributor carrying out any activity in Article 16(2) shall, at least 28 days prior to relabelling or repackaging the device, inform the competent authority and manufacturer of their intentions, and provide a draft copy of the amended material upon request. In addition to that, Article 16(4) requires that such an importer or distributor must also request an appropriate notified body to assess that their procedures are in place with respect to the activities they are carrying out and issue a certificate which must then be provided to the relevant Competent Authority.
How Can Specculo Help? #
We help importers understand their obligations and guide them into setting up systems to enable them to continuously comply with the requirements of the EU Medical Device Regulation 2017/745 and IVD Regulation 2017/746. See the following service pages for more information or contact us today to see how we can help you further.