MDCG 2022 16
The Medical Device Regulation 2017/745 [MDR] and In Vitro Diagnostic Regulations 2017/746 [IVDR] enhanced the focus on the safety and conformity of medical devices. Under this regime, the responsibility of the EU Authorised Representative [EU AR] has constantly been increasing. These 2 regulations also required the appointment of a Person Responsible for Regulatory Compliance [PRRC].
From the latest guidance for EU AR, our experts recall that the role of EU AR is not just being a ‘post box’, for non EU manufacturer but is a lot more complex responsibility where the EU AR shares the same legal responsibility to that of a non EU Manufacturer.
Let’s say that a Medical Device Manufacturer in the USA, would like to sell their products in the EU. Apart from having a Distributor and Importer, the USA manufacturer needs to appoint an EU Authorised Representative who will:
- Verify that the manufacturer’s device has undergone the appropriate conformity assessment
- Ensure that the Declaration of Conformity and the technical documentation has been completed
- Cooperate with Competent Authorities on any corrective or preventative actions
- Immediately inform the manufacturer of any complaints or complaints related to their devices
- Provide Competent Authorities with any information or documentation required to demonstrate that the device meets conformity
Key Highlights from the Guidance MDCG 2022 - 16
- Where a 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 authorised representative (Article 11(1) MDR and IVDR).
- Generic device group: a set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics (Article 2(7) MDR and Article 2(8) IVDR).
- As regards its portfolio of devices therefore, a manufacturer can have more than one authorised representative if the devices fall under different generic device groups.
- for one specific generic device group, the manufacturer should designate only one authorised representative.
- The manufacturer and the authorised representative are free to configure the structure of their contractual relationship as they see appropriate, as long as there is a written mandate that meets the minimum requirements of Article 11(3) of the Regulations and the content of which is agreed between the parties.
- Upon request, the authorised representative has to provide a copy of the mandate to the competent authority.
- The manufacturer could for instance mandate the authorised representative to lodge, on its behalf, an application for conformity assessment according to annex IX, X, XI MDR/IVDR with a notified body at the pre-market stage.
- Importers should verify that the authorised representative in accordance with Article 11 has been designated by the manufacturer.
- According to the Article 11(5) of the Regulations the authorised representative is legally liable for defective devices under the following terms: “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 authorised representative shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer”
Manufacturers, Importers and EU Authrosied representatives must focus on enhanced collaboration to ensure compliance with all regulatory requirements!
A non-compliant party can face serious consequences, fines, penalties and other legal actions, which may also mean delisting the medical devices from the European Union Market.
Make sure you have the right team of experts guiding the regulatory requirements. Our experts are here to provide all Medical Manufacturers with complete support and regulatory representation.
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