EU importer of medical devices
If you are looking to expand your business by exporting your medical device to Europe, you have to comply with the new Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR).
The MDR and IVDR introduced an economic operator (EO) regime covering the entire supply chain to the end-user. It includes the manufacturer, authorized representative, importer, and distributor. We focus on the role of the EU importer of medical devices and combine it with our 3PL services to create a level playing field for non-EU manufacturers.
What has changed?
The new MDR and IVDR brings EU legislation in line with technical advances, changes in medical science, and progress in law making. It creates a robust, transparent, and sustainable regulatory framework, that is internationally recognized and reduces the risks of discrepancies in interpretation across the EU market.
In general, the MDR and the IVDR keep all the requirements of the Directives, while adding some new requirements of their own. Compared to the old (but still applicable) Directives, the new Regulations emphasize a life-cycle approach to safety, backed up by clinical data.
The Regulations add more stringent rules for the designation of Notified Bodies. For national competent authorities and the Commission, they add more control and monitoring requirements. Other important parts of the regulations clarify the obligations of manufacturers, authorised representatives, importers and distributors.
The EO regime is not new. The functioning of the CE marking system and all concepts relating to EOs, such as the core concept of ‘placing on the market’, ‘making available’, as well as the EOs in the product supply chain and their obligations, are explained in detail in the Blue Guide.
Placing on the market and making available
The MDR and IVDR now explicitly define and list the obligations of Manufacturers, Authorized Representatives, Importers, and Distributors. The obligations force manufacturers to reconsider their supply chain and that all companies currently in the process know what role they have in the supply chain. Each role of the EO is defined in the MDR and IVDR along with crucial concepts of ‘placing on the market’ and ‘making available.’ These concepts are determinative for the regulatory responsibilities imposed by the MDR and the IVDR on the various EOs in the medical devices supply chain.
The new legislative framework introduces the logic that all EOs (except the authorized representative) make products available on the EU market. ‘Making available’ means:
“…any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge”
A product is ‘placed on the market’ when it is ‘made available’ for the first time on the Union market. Placing a product on the market is reserved for – and can only be done by – manufacturers and importers. When a manufacturer or an importer supplies a product to a distributor or an end-user for the first time, the operation is always labelled in legal terms as ‘placing on the market’. Any subsequent operation, for instance, from a distributor to distributor or from a distributor to an end-user is defined as ‘making available’.
Traceability and transparency
EU Distributors and EU Importers of medical devices have to co-operate with manufacturers and/or authorised representatives to achieve an appropriate level of traceability of devices. They must keep the UDIs for Class III implantable devices. The obligation to keep UDIs for these devices also applies to health institutions and EU member states may extend this obligation on health institutions to other devices as well.
The Regulations increase transparency, requiring the publication of information on devices and on clinical and performance studies related to their conformity. The European Database for Medical Devices and In Vitro Diagnostic Medical Devices is named EUDAMED and plays a central role in making data available and increasing both the quantity and quality of data.
These new EU MDR import and distribution requirements for medical devices expand regulatory due diligence from legal manufacturer to importers and distributors. Each EO must verify regulatory compliance independently and generate its own records of compliance and be aware that they may be subject to unannounced audits. More important than ever, EOs must confirm compliance with all partners.
Regulation
Check the next tabs to view Article 13 and 14 of the MDR for the general obligations of EU importers and EU distributors.
Article 13 General obligations of importers
1. Importers shall place on the Union market only devices that are in conformity with this Regulation.
2. In order to place a device on the market, importers shall verify that:
- the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;
- a manufacturer is identified and that an authorised representative in accordance with Article 11 has been designated by the manufacturer;
- the device is labelled in accordance with this Regulation and accompanied by the required instructions for use;
- where applicable, a UDI has been assigned by the manufacturer in accordance with Article 27.
Where an importer considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, it shall not place the device on the market until it has been brought into conformity and shall inform the manufacturer and the manufacturer’s authorised representative. Where the importer considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which the importer is established.
3. Importers shall indicate on the device or on its packaging or in a document accompanying the device their name, registered trade name or registered trade mark, their registered place of business and the address at which they can be contacted, so that their location can be established. They shall ensure that any additional label does not obscure any information on the label provided by the manufacturer.
4. Importers shall verify that the device is registered in the electronic system in accordance with Article 29. Importers shall add their details to the registration in accordance with Article 31.
5. Importers shall ensure that, while a device is under their responsibility, storage or transport conditions do not jeopardise its compliance with the general safety and performance requirements set out in Annex I and shall comply with the conditions set by the manufacturer, where available.
6. Importers shall keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and provide the manufacturer, authorised representative and distributors with any information requested by them, in order to allow them to investigate complaints.
7. Importers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this Regulation shall immediately inform the manufacturer and its authorised representative. Importers shall co-operate with the manufacturer, the manufacturer’s authorised representative and the competent authorities to ensure that the necessary corrective action to bring that device into conformity, to withdraw or recall it is taken. Where the device presents a serious risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available and, if applicable, the notified body that issued a certificate in accordance with Article 56 for the device in question, giving details, in particular, of the non-compliance and of any corrective action taken.
8. Importers who have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device which they have placed on the market shall immediately forward this information to the manufacturer and its authorised representative.
9. Importers shall, for the period referred to in Article 10(8), keep a copy of the EU declaration of conformity and, if applicable, a copy of any relevant certificate, including any amendments and supplements, issued in accordance with Article 56.
10. Importers shall cooperate with competent authorities, at the latters’ request, on any action taken to eliminate or, if that is not possible, mitigate the risks posed by devices which they have placed on the market. Importers, upon request by a competent authority of the Member State in which the importer has its registered place of business, shall provide samples of the device free of charge or, where that is impracticable, grant access to the device.
Article 14 General obligations of distributors
1. When making a device available on the market, distributors shall, in the context of their activities, act with due care in relation to the requirements applicable.
2. Before making a device available on the market, distributors shall verify that all of the following requirements are met:
- the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;
- the device is accompanied by the information to be supplied by the manufacturer in accordance with Article 10(11);
- for imported devices, the importer has complied with the requirements set out in Article 13(3);
- that, where applicable, a UDI has been assigned by the manufacturer.
In order to meet the requirements referred to in points (a), (b) and (d) of the first subparagraph the distributor may apply a sampling method that is representative of the devices supplied by that distributor.
Where a distributor considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, it shall not make the device available on the market until it has been brought into conformity, and shall inform the manufacturer and, where applicable, the manufacturer’s authorised representative, and the importer. Where the distributor considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which it is established.
3. Distributors shall ensure that, while the device is under their responsibility, storage or transport conditions comply with the conditions set by the manufacturer.
4. Distributors that consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, the manufacturer’s authorised representative and the importer. Distributors shall co-operate with the manufacturer and, where applicable, the manufacturer’s authorised representative, and the importer, and with competent authorities to ensure that the necessary corrective action to bring that device into conformity, to withdraw or to recall it, as appropriate, is taken. Where the distributor considers or has reason to believe that the device presents a serious risk, it shall also immediately inform the competent authorities of the Member States in which it made the device available, giving details, in particular, of the non-compliance and of any corrective action taken.
5. Distributors that have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device they have made available, shall immediately forward this information to the manufacturer and, where applicable, the manufacturer’s authorised representative, and the importer. They shall keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and keep the manufacturer and, where available, the authorised representative and the importer informed of such monitoring and provide them with any information upon their request.
6. Distributors shall, upon request by a competent authority, provide it with all the information and documentation that is at their disposal and is necessary to demonstrate the conformity of a device.
Distributors shall be considered to have fulfilled the obligation referred to in the first subparagraph when the manufacturer or, where applicable, the authorised representative for the device in question provides the required information. Distributors shall cooperate with competent authorities, at their request, on any action taken to eliminate the risks posed by devices which they have made available on the market. Distributors, upon request by a competent authority, shall provide free samples of the device or, where that is impracticable, grant access to the device.
Since we can handle the warehousing and order fulfillment of your products, we can also accept the role of importer for the EU market. Together with you (the manufacturer) we take the responsibility. As your registered EU importer, we comply with the importer requirements stipulated in the European Regulations to prevent your distributors from this burden.
