July 13th, 15th, 22nd and August 3rd, 2021, new guidance documents were released by the Medical Device Coordination Group (MDCG). These new documents provide explanatory notes on the IVDR codes (MDCG 2021-14), introduce four forms to be used by conformity assessment bodies when applying for designation under the MDR or IVDR (MDCG 2021-15,16,17 and 18), provide guidance on the integration of UDI within an organisation’s QMS (MDCG 2021-19), provide instructions for generating CIV-ID for MDR Clinical Investigations (MDCG 2021-20) and provide guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices (MDCG 2021-21).
MDCG 2021-14 Explanatory note on IVDR codes
This guidance is intended to explain the different levels of codes, established in Annex II of the Commission Implementing Regulation 2017/2185, and how they should be used, including the use of conditions to ensure a harmonised use of the codes especially for the allocation of resources to conformity assessment activities. In this guidance document each type of code is presented, an explanation is given on how the code is to be applied and how many of each code can or should be assigned to each device. For example, the “IVR” code reflecting the design and intended purpose of the device should be used exactly once per device, while 1 to several “IVP” horizontal codes, describing the main examination procedures, may be assigned per device.
MDCG 2021-15 Application form to be submitted by a conformity assessment body when applying for designation as notified body under the medical devices regulation (MDR)
MDCG 2021-16 Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices regulation (IVDR)
MDCG 2021-17 Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR)
MDCG 2021-18 Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR)
These forms are intended for conformity assessment bodies.
MDCG 2021-19 Guidance note integration of the UDI within an organisation’s quality management system.
This document provides guidance on the integration of the UDI and the implementation of the UDI obligations as part of an organisation’s Quality Management System (QMS) as required by Article 10(9)(h) MDR and 10(8)(h) IVDR. Economic operators concerned include manufacturers, in the case of Article 16(1) MDR/IVDR a distributor, importer or any other natural or legal person that assumes the obligations incumbent on manufacturers, and in case of Article 22(4) MDR the natural or legal persons that assumes the obligations incumbent on manufacturers.
The guidance explains how UDI and Basic UDI-DI assignment, and management of the UDI-related information can impact many other lifecycle QMS processes. Manufacturers are thus urged to establish a UDI implementation plan and use appropriate implementation tools as described in its QMS to allow correct assessment/decisions to be made and the proper documented evidence to be created. This to ensure compliance with the Regulations regarding the UDI-system.
The guidance also provides advice on integrating UDI obligations into different areas of a manufacturer’s QMS such as design and development, product documentation and retention, Production and process, serious incidents, and field safety corrective actions etc. The annexes provide a list of steps that should be considered when implementing UDI processes into a QMS, an example of a UDI implementation plan, and recommendations for notified bodies on auditing the implementation of the UDI system.
MDCG 2021-20 Instructions for generating CIV-ID for MDR Clinical Investigations.
For clinical investigations under the MDR the Competent Authorities use EUDAMED2 to obtain a Union-wide unique single identification number (the ‘CIV-ID’), upon submission of the required information to EUDAMED2. The instructions covered within this guidance are thus only applicable to Competent Authorities who currently have access to EUDAMED2.
MDCG 2021-21 Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices.
This guidance document addresses the performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices (IVDs) in the context of conformity assessment under either Directive 98/79/EC or IVDR. It covers devices for detection or quantification of SARS-CoV-2 nucleic acid, antigens and detection or quantification of antibodies against SARS-CoV-2. These devices are collectively referred to as SARS-CoV2 IVDs.
The content of this guidance document is envisaged to form the basis for the future common specifications to be adopted according to Article 9 of the IVDR in the coming months. The content may be adapted to take account of changing circumstances and increasing scientific and technical knowledge, as the COVID-19 pandemic continues to evolve.
What does this mean to you?
MDCG 2021-14 is a crucial document to help you assign the appropriate codes to your devices. These codes are required in order for you to select an appropriate Notified Body who has been designated for the codes applicable to your device, and for the Notified Body to ensure that the team allocated for the conformity assessment of a device has adequate knowledge and expertise.
MDCG 2021-19 provides useful advice and insights to manufacturers on how to ensure that the UDI system and the UDI obligations incumbent on manufacturers is integrated into their QMS.
MDCG 2021-21 is an invaluable guidance for all parties involved in the manufacture and bringing to the EU market of SARS-CoV-2 IVD devices. It addresses the performance evaluation requirements for such devices and forms the basis for a future Common Specification for SARS-CoV-2.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.
