In this article we are going to analyze the questions and answers regarding the new European Regulation 2017/745 or MDR (Medical Device Regulation).
Recall that we are among the first Italian companies to have obtained MDR certifications for some of our medical devices.
How are economic operators regulated in the new MDR regulation?
In the MDD (Medical Device Directive) only the figures of the manufacturer and the authorized representative were regulated.
The MDR introduces important innovations for economic operators.
More precisely, it strengthens the roles and tasks of the manufacturer (Art. 10) and the authorized representative (Art. 11 and 12) and introduces a specific discipline (which did not exist before) regarding the figure of the importer (Art. 13) and the distributor (Art. 14).
Economic operators then all have a traceability obligation (Art. 25) in relation to the DMs they market.
In addition, the Regulation introduces the Person Responsible for Compliance (Art. 15): this is an individual who must be appointed by Manufacturers and Authorized Representatives and who plays an “internal control” role within the company about compliance with medical device regulations.
What are the new obligations and roles of the authorized representative?
An authorized representative is “Any natural or legal person established in the Union who has received and accepted from the manufacturer, established outside the Union, a written mandate authorizing him or her to act on behalf of the manufacturer in relation to certain activities with respect to the manufacturer’s obligations under the MDR.”
What are the obligations to be fulfilled by importers and distributors?
In 2008 with the new legislative framerwork these figures were going to be outlined.
In the MDR (Medical Device Regulation) the figures of the importer and distributor are regulated correspondingly in Art.13 and Art.14, tracing the information contained in the new legislative framework.
What are legacy devices?
Devices defined as “legacy” include: medical devices, active implantable medical devices, and in vitro diagnostic medical devices-covered by a valid directive certificate-that will continue to be placed on the market after the date of application of Regulation (EU) 2017/745 (MDR) or Regulation 2017/746 (IVDR).
What is the difference between “placing on the market” and “making available“?
In order to fully understand Article 120 MDR (Medical Device Regulation) and its application a distinction must be made between two legal concepts:
In the MDR (Medical Device Regulation), the activity of “placing on the market” is described as the first making available of a device on the Union market (Art. 2.28), and by “making available” is meant the supply of a device for distribution, consumption or use on the Union market in the course of a commercial activity, whether for consideration or free of charge (Art. 2.27).
When is a change to a medical technical file considered significant under Art. 120(3) MDR?
A Medical Device Manufacturer with a valid certificate issued by a Notified Body under Directive 90/385/EEC (AIMDD) or Directive 93/42/EEC (MDD) may place its devices on the market even after May 26, 2021 (date of full implementation of MDR (EU) 2017/745) and no later than May 27, 2024.
As defined by Art. 120 para. 3 of the MDR, “A device with a certificate issued under the MDD/AIMDD may be placed on the market, provided there is no significant change in design and intended use.”
Repackaging and translation activities: what are the acts/operations that transform the person into a manufacturer?
Art. 16 of the European Regulation 2017/745 MDR goes on to specify in Paragraph 1 what are the acts/operations, where performed on the medical device, that transform the subject into a manufacturer; conversely, the following paragraphs 2-3-4 explain how the two activities of translations of use information and repackaging can be implemented without involving the acquisition of the role of a manufacturer, while complying with some specific requirements.
The proposed amendment to European Regulation 2017/745. What are the salient points?
The proposal to amend the European Regulation 2017/745 MDR and the European Regulation 2017/746 IVDR, announced on December 9 during the EPSCO meeting came earlier than expected and was already published on the European Commission’s Medical Device website on January 6.
As a reminder, the proposed amendment to European Reg. 2017/745 MDR has been approved. Keep following us to learn more.
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