On May 26, 2020 the new European regulations n. 2017/745 on medical devices (MDR) and n. 2017/746 on in vitro diagnostic medical devices (IVD) entered into force.
The regulations introduce new obligations for importers and distributors of these products, which were not regulated in the previous law.
The purpose of this new regulations is to ensure that each economic operator guarantees compliance with the regulatory requirements for the marketing of medical devices, by controlling the work of the previous subject in the product distribution chain (manufacturer, authorized representative, importer and distributor).
Limitation of liability may be established by specific contractual provisions between the parties. Please find below the definition of each subject and its obligations.
Manufacturer and authorized representative
The manufacturer is defined in Article 2 paragraph 30 of the MDR and IVD as “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”.
The obligations of the manufacturer are listed in art. 10 of the MDR and IVD and refer to requirements regarding the design of the device, the quality and risk management system, the affixing of the CE marking of conformity and the drafting of the technical file.
When the manufacturer is based outside the European Union, he has the obligation to appoint an authorized representative based in the European Union, who acts on his behalf for the fulfillment of certain obligations established by law and who interfaces with the competent public authorities in the European market.
The obligations of the European representative are indicated in Article 11 MDR and IVD and include, but not limited to, the following:
Check that the EU declaration of conformity and the technical file have been drawn up.
Keep all technical documents and, upon request, make them accessible to the authorities.
Record the required information in the EUDAMED database
Inform the manufacturer, without delay, on any complaints and device sample requests by public authorities.
The authorized representative will be responsible for the defective devices jointly with the manufacturer, if the latter has not fulfilled its obligations under Article 10 MDR and IVD and is not based in the EU (Article 11, paragraph 5, of the MDR and IVD ).
Finally, art. 16 of the MDR and IVD identifies the cases in which the obligations of manufacturers apply to importers and distributors. These cases refer to any type of intervention on the product, packaging and transport (e.g. affixing name or brand on the packaging, changing the intended purpose of a device already placed on the market or put into service).
The importer is defined in art. 2 paragraph 33 of the MDR and IVD as " natural or legal person established within the Union that places a device from a third country on the Union market". Therefore, an "importer" is someone who buys a product from a non-European supplier and not someone who buys the same product from a European supplier.
The obligations of the importer are listed in Article 13 of the MDR and IVD and include, but are not limited to, the following:
Check that the CE marking has been affixed and that the EU declaration of conformity has been drawn up
Check that the manufacturer and his European representative are identified in the package and are registered in the EUDAMED database
Check that the device is properly labeled and accompanied by the prescribed instructions for use and equipped with a UDI vector (barcode or matrix code)
Keep a register of complaints, non-compliant devices and withdrawals, and inform manufacturers and their European representatives and the competent authorities.
Indicate on the device or on its packaging or in a document accompanying the device their name, registered trademark, address, ensuring that any additional label does not obscure any information on the label provided by the manufacturer.
Article 2, paragraph 34 of the MDR defines it as “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”.
The obligations of the distributor are indicated in Article 14 MDR and IVD and include activities similar to those envisaged for the importer, excluding the obligation to indicate their data on the device or its packaging or in a document accompanying the device.
What is the CE marking of medical devices?
The CE marking is a mandatory procedure to be able to market a medical device on the European market. This procedure varies according to the class of the medical device (I, IIa, IIB and III). For more complex medical devices (class IIa, IIb and III), the procedure requires the intervention of a Notified Body. For the list of authorized notified bodies click here
The certificate issued by the Notified Body do not replace the CE marking of medical devices, but it is a step of the CE marking procedure.
The non-European manufacturer cannot carry out the CE marking, even if its products comply with the laws, but must delegate a European representative to follow this procedure.
What is the Technical File?
The technical file is a collection of information and documents that describe in detail the medical device and the aspects related to the safety and efficacy of the product. This document must always be updated and, with the exception of class I medical devices, in vitro diagnostic medical devices included in Annex II of EU regulation 2017/746 and self-diagnostics, must be evaluated by a Notified Body to obtain the CE marking.
Import of Masks in Italy
Until the COVID-19 emergency continues, surgical masks and PPE without CE marking can be imported, subject to ISS / INAIL authorization. For more details, see the guide prepared by Confindustria, which can be downloaded in Italian by clicking here.
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