On March 24th, 2022, the Medical Device Coordination Group (MDCG) released a revision to an existing guidance. In addition, on April 26th and May 4th the MDCG released two new documents. The previously released guidance on the summary of safety and clinical performance, a guide for manufacturers and notified bodies (MDCG 2019-9) was updated to revision 1. While the two new documents provide guidance on the borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices (MDCG 2022-5) and offer guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR (MDCG 2022-6).
MDCG 2019-9 Rev. 1 – Summary of safety and clinical performance. A guide for manufacturers and notified bodies.
This document provides guidance on the presentation, content and validation of the Summary of Safety and Clinical Performance (SSCP) that needs to be drawn up by manufacturers of implantable devices and class III medical devices, other than custom-made or investigational devices, as per MDR 2017/745 Article 32.
In this first revision changes have been made to section 3.1 to provide some clarification on the association of the SSCP with the Basic UDI-DI in EUDAMED. In the general requirements and templates, a manufacturer reference number was also added.
MDCG 2022-5 Guidance on borderline between ,edical devices an medicinal products under Regulation (EU) 2017/745 on medical devices.
The differentiation between the Medical Device Regulation 2017/745 (MDR) on the one hand and the Medicinal Products Directive 2001/83/EC (MPD) on the other hand is crucial for the proper implementation of these pieces of legislation and their correct interpretation and enforcement. Several provisions to differentiate between the two legal frameworks have been laid down in the MDR and MPD. This new guidance document provides further clarifications and examples explaining these provisions in order to support the uniform application of the MDR across the EU.
The guidance starts with a general discussion of the borderline between medical devices and medicinal products, including relevant definitions and examples. Separate chapters are dedicated to herbal products, substance-based devices and combination products that consist of a combination of a medical device and a medicinal product.
MDCG 2022-6 – Guidance on significant changes regarding the transitional provision under Article 110 (3) of the IVDR.
Article 110(3) of the IVDR, as amended by Regulation (EU) 2022/1121, states that under certain conditions certain devices may be placed on the market or put into service after the date of application of the IVDR, i.e., 26 May 2022, until the end of the different transition periods specified in Article 110(3) IVDR. The conditions for the application of the transitional provisions in Article 110(3) IVDR are that the devices continue to comply with the IVDD 98/79/EC and that there are no significant changes in the design or intended purpose of the device after the date of application of the IVDR.
This guidance provides clarification on the changes to a legacy device that should be considered a “significant change in design or a significant change in the intended purpose” under IVDR Article 110(3).
The manufacturer always remains responsible for providing evidence that changes neither affect the design nor the intended purpose. When a change is likely to affect the design or the intended purpose of the device, the significance of such a change should be assessed case-by-case providing evidence for the outcome of the assessment. The manufacturer must be able to justify their decision when the changes are considered to be non-significant. The justification shall be documented and made available to a competent authority when requested.
If a change is not a significant change in design or intended purpose under IVDR Article 110(3), the implementation of such a change is allowed during the transitional period without the need for certification under the IVDR. In such cases, the manufacturer needs to comply with the documentation requirements of the IVDD, i.e., the updated technical documentation must allow assessment of the conformity of the product with the applicable requirements.
To help manufacturers and notified bodies in judging the significance of the changes, the guidance includes five flow charts asking questions related to different factors.
What does this mean to you?
MDCG 2019-9 Rev 1 is an invaluable guidance when creating your Summary of Safety and Clinical Performance. For IVD manufacturers it can already be used a s a source of inspiration for their Summary of Safety and Performance.
MDCG 2022-5 contains some very valuable insights when you are faced with a product of which you must determine if it falls under the MDR or the MPD. It can also provide useful information for combination devices, that thus consist of a medical device and medicinal product part.
MDCG 2022-6 is an invaluable guidance for all manufacturers of IVD legacy devices as it helps them in their assessment of changes during the transitional period. Manufacturers should adjust their change control procedures to include an assessment of the significance of changes made to a device in order to adequately determine if the change triggers the immediate implementation of the IVDR or if it is still allowed during the transitional period in which the device is in essence frozen.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.