Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorized representative.

The designation shall constitute the authorized representative's mandate, it shall be valid only when accepted in writing by the authorized representative and shall be effective at least for all devices of the same generic device group.

The authorized representative shall perform the tasks specified in the mandate agreed between it and the manufacturer. The authorized representative shall provide a copy of the mandate to the competent authority, upon request.

The mandate shall require, and the manufacturer shall enable, the authorized representative to perform at least the following tasks in relation to the devices that it covers:

verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;

keep available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 56, at the disposal of competent authorities for the period referred to in Article 10(8);

comply with the registration obligations laid down in Article 31 and verify that the manufacturer has complied with the registration obligations laid down in Articles 27 and 29;

in response to a request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the Member State concerned;

forward to the manufacturer any request by a competent authority of the Member State in which the authorized representative has its registered place of business for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device;

cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;

immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated;

terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.

The mandate referred to in paragraph 3 of this Article shall not delegate the manufacturer's obligations laid down in Article 10(1), (2), (3), (4), (6), (7), (9), (10), (11) and (12).

Without prejudice to paragraph 4 of this Article, where the manufacturer is not established in a Member State and has not complied with the obligations laid down in Article 10, the authorized representative shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer.

An authorized representative who terminates its mandate on the ground referred to in point (h) of paragraph 3 shall immediately inform the competent authority of the Member State in which it is established and, where applicable, the notified body that was involved in the conformity assessment for the device of the termination of the mandate and the reasons therefor.

Any reference in this Regulation to the competent authority of the Member State in which the manufacturer has its registered place of business shall be understood as a reference to the competent authority of the Member State in the authorized representative, designated by a manufacturer referred to in paragraph 1, has its registered place of business.

AUREPS will soon offer the following service to fulfill its role as EC Representative according to Regulation (EU) 2017/745 on medical devices (MDR) based on the AUREPS intelligent data management system:

• Communication to the relevant Competent Authorities within the EU
• Data Management for your Technical documentation
• Check of quality and completeness of the Technical documentation
• Registration of Manufacturer and product scope in the EUDAMED database
• Maintenance of the EUDAMED database
• Storage of device samples
• Development of a Post Market Surveillance Plan for each product family
• Assistance in creation of annual Post Market Surveillance Reports
• Assistance in creation of Periodical Safety Update Reports (PSUR)
• Assistance in creation and maintenance of SSCP´s
• Adverse Event Reporting

According to MDD (MDD 93/42/EEC and MEDDEV 2.12-1.) regulations the role of the EAR has been limited to product registration and incident reporting in case of product recalls or failures. 

From May 26th 2020 all manufacturers of medical devices need to have the requirements of Regulation (EU) 2017/745 on medical devices (MDR) implemented. 

According to MDR the EAR is playing a major role in data management for the manufacturer including maintenance of data in the newly established EUDAMED database. Furthermore, the development of Post Market Surveillance Reports and Periodical Safety Update Reports (PSUR) are essential new requirements as the EAR together with the manufacturer will be held jointly and severally liable for defective medical devices.

Concluding we can say that the EAR takes on more risks and liabilities under the MDR which must be addressed. 

AUREPS supports manufactures of medical devices to fulfill all these requirements offering tailor-made solutions to address all matters for both OEM / PLM manufactures as well as for manufactures having their products manufactured in their own premises. 

From May 26th 2020 all manufacturers of medical devices need to have the requirements of Regulation (EU) 2017/745 on medical devices (MDR) implemented. According to Article 16 the regulatory requirements for Private Label Products have dramatically changed:

Article 16

Cases in which obligations of manufacturers apply to importers, distributors or other persons

1.A distributor, importer or other natural or legal person shall assume the obligations incumbent on manufacturers if it does any of the following:

(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;

(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. The first subparagraph shall not apply to any person who, while not considered a manufacturer as defined in point (30) of Article 2, assembles or adapts for an individual patient a device already on the market without changing its intended purpose.

2.For the purposes of point

(c) of paragraph 1, the following shall not be considered to be a modification of a device that could affect its compliance with the applicable requirements:

(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;

(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.

Conclusion:

According to bullet point 1(a), a Privat Label Manufacturer (PLM) who receives devices from an Original Equipment Manufacturer (OEM) needs access to the OEM´s complete Technical Documentation including sub suppliers, materials, processes, validations and test procedures to achieve a successful conformity assessment by the PLM´s notified body.

• Definition of required Technical Documentation
• Pre-Assessment of Technical Documentation regarding completeness and quality
• Data Management by AUREPS specialized medical device database
• Contract Management in compliance with MDR requirements
• Support in the communication with the PLM´s Notified Body.