Below we provide an overview of:

1. The new IMDRF Table of Contents for IVDs and non-IVDs
2. The guidances relevant to a specific subset of manufacturers. Most of these guidance documents are specific to 1) certain types of medical devices, 2) certain types of situations, or 3) related to Notified Body designation, which do not have a direct impact on medical device manufacturers.

IMDRF Table of Contents (ToCs)

On 25 June 2024 the IMDRF published updates versions of the IVD and non-IVD Table of Contents (Edition 4). The previous versions were issued March 2019.

The purpose of the ToCs are:

“To create a comprehensive submission structure that minimizes regional divergences and indicates where regional variation exists. This document is intended to provide guidance regarding the location of submission elements in the internationally defined structure.

This document is not intended to introduce any new regulatory requirements.”

The ToCs consider the requirements for:

• Australian TGA
• Brazil ANVISA
• Health Canada
• China NMPA
• European Union
• Japan PMDA
• Singapore HSA
• UK MHRA*
• US FDA

*UK specific differences are not itemized; however, the UK and MHRA are defined acronyms with likely intent to be included in a future revision.

MDCG 2024-10: Clinical Evaluation of Orphan Medical Devices

MDCG 2024-10, published 25 June 2024, to help manufacturers of orphan devices, which are devices that have a small patient population, treating rare diseases/conditions.

Due to the, by nature, lower volume of sales, the guidance acknowledges the “increased, and at times unpredictable, financial costs associated with compliance with MDR” can make it more challenging for manufacturers to supply these devices. And, that the application of the MDR requirements should be “balanced and proportionate”, to meet patient safety while also not hindering access to these devices.

MDCG 2024-10 provides clarification around:

• The criteria for classifying a device as an orphan medical device
• Guidelines for clinical evaluation, which is particularly challenging considering the small patient populations and limited clinical data available
• Guidance on implementing a post-market surveillance system
• Procedural considerations, including consulting with Expert Panels where appropriate

MDCG 2022-13 Rev. 1: Designation, re-assessment, and notification of Notified Bodies

The purpose of MDCG 2022-13 is to ensure a harmonized and robust process for assessing and designating conformity assessment bodies (CABs) and notified bodies (NBs) under the EU MDR/IVDR.

MDCG 2022-13 Rev. 1, was published 17 June 2024. It was updated to “…include guidance on the conduct of joint assessments relating to extending the scope of designations.”

MDCG 2024-1-5: Vigilance for Urogynaecological Surgical Mesh Implants

MDCG 2024-1-5 is a supplementary guidance related to MDCG 2024-1 on Device Specific Vigilance Guidance (DSVG) Templates.

Please read more about MDCG 2024-1, as a whole, here.

SCHEER Guides for Phthalates

Manufacturers of medical devices which contain phthalates may have already been following the recent EU consultation to update the guidelines.

The outcome is that the European Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) has published the final updated guidelines, available here.

If your products contain one or more of the following properties, you must justify their presence under MDR Annex I, GSPR 10.4.3: carcinogenic, mutagenic, toxic to reproduction (CMR) or endocrine-disrupting (ED). The new document provides guidelines on the benefit-risk assessment of the presence of phthalates.