Medical Device Coordination Group (MDCG) updates – January to March 2023

DateGuidance NoAbout the guidance
14 Feb 2023MDCG 2023-3 – Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices – February 2023This document aims to clarify important terms and concepts that are outlined in Section 2 of Chapter VII of the Regulation (EU) 2017/745 on medical devices (MDR). Establishing a
common understanding of these terms and concepts is necessary for an effective and harmonised implementation of the vigilance requirements under the MDR. The document is written for competent authorities, economic operators and other relevant parties.
10 Feb 2023MDCG 2020-16 Rev.2 – Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 – February 2023This guidance, relating to the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) addresses the classification of in vitro diagnostic medical devices (IVDs) and provides clarifications on the classification rules as set out under Annex VIII. This classification guidance also applies to diagnostic or information society services performed on EU patients or devices put in to service through distance sales.

This update concerns revised examples in Rule 5b.
12 Jan 2023MDCG 2023-2 – List of Standard Fees – January 2023Article 50 of Regulation (EU) 2017/745 on Medical Devices (MDR) and Article 46 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish the requirement for notified bodies to make their standard fees publicly available: “Notified bodies shall establish lists of their standard fees for the conformity assessment activities that they carry out and shall make those lists publicly available“. Neither the MDR nor the IVDR do provide any definition of “standard fees” itself.

When setting their fees, Notified Bodies also need to consider Annex VII 1.2.8 of the MDR and IVDR about their terms and conditions being fair and reasonable and taking into account the interest of small and medium-sized enterprises as defined in Recommendation 2003/361/EC.

MDCG clarified the meaning of “publicly available”, which “implies that a member of the public can access this information at any point in time, without the need for additional steps.” (MDCG guidance 2019-6 section V.2.). This implies the list of fees of each notified body should be directly and easily accessible on the website of the notified body without any additional steps, e.g. without the need to register as a user of the website or provide contact data. This website should be the website registered for the notified body on NANDO and not a different website of another organization. The format of the standard fee table could be any that is accessible on a common website browser.

The currency shown should be relevant to the country where the notified body has its registered place of business (in line with the information provided in NANDO). If there are regional differences in fees charged depending on the location of manufacturer, this should also be indicated.

The list of standard fees should be written in the same language as the website of the notified body. In case of multiple language formats, the list should be also available in the same language.
10 Jan 2023MDCG 2023-1  Guidance on the health
institution exception under Article 5(5)
of Regulation (EU) 2017/745 and
Regulation (EU) 2017/746 – January 2023		Medical devices can be manufactured and used within EU health institutions (in-house devices), on a non-industrial scale, to address the specific needs of target patient groups which cannot be met, or cannot be met at the appropriate level of performance, by an equivalent CE-marked device available on the market. In-house medical devices are exempted from most of the provisions of Regulations (EU) 2017/745 (medical devices Regulation, MDR) and (EU) 2017/746 (in vitro diagnostic medical devices Regulation, IVDR), provided the health institution adheres to the conditions laid out in Article 5(5) of the relevant Regulation. In order to ensure the highest level of health protection, Article 5(5) sets a number of rules regarding the manufacture and use of such in-house medical devices.

The provisions in Article 5(5) are the basis for the regulatory control and oversight of inhouse devices. This document provides guidance on the application of some of these rules. It is written for healthcare professionals and researchers of health institutions aiming to design, manufacture, modify and use in-house devices. In addition, this guidance document intends to foster harmonised application of Article 5(5) by the national competent authorities.

Both Regulations also state that any natural or legal person offering diagnostic or therapeutic services through distance sales to patients in the Union must use devices that comply with the MDR or IVDR (Article 6(2)). Of importance here is that the exemption provision from Article 5(5) is only applicable to health institutions within the Union.