December “In All Other News”: Revised MDCG Docs, Team NB Guide on MDR Certification Stages & more
3 January 2025
MDCG Updates: Status of MIR, FSCA, Trend Report Forms & Guidance, and MDCG 2023-3 Revised
8 January 2025Expand Well-Established Technologies List
Initiative Published: HERE
| Summary: The proposed delegated act will expand the list of well-established technologies referred to Regulation (EU) 2017/745 on medical devices with a view to exempting them from some legal requirements and reduce administrative burden, without compromising health and safety. |
| Type of act: Delegated regulation |
| Draft act: Feedback Upcoming |
| Commission adoption: Planned for Third quarter 2025 |
Background
Under the MDR, examples of ‘well-established technologies’ (WET) are those listed in Article 61(6)(b): sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors. Article 61(8) allows for the expansion of this list via a delegated act. Per MDCG 2020-6, common characteristics for well-established technologies include:
- relatively simple, common and stable designs with little evolution;
- their generic device group has well-known safety and has not been associated with safety issues in the past;
- well-known clinical performance characteristics and their generic device group are standard of care devices where there is little evolution in indications and the state of the art;
- a long history on the market.
Reclassification of Well-Established Technologies
Initiative published: HERE
| Summary: Regulation (EU) 2017/745 on medical devices provides rules to classify devices in one of the four risk classes (class I, IIa, IIb and III) depending on their intended use and inherent risk. With this implementing act, the Commission aims to reclassify certain well-established technologies, for which the application of the general classification rules in Annex VIII of Regulation (EU) 2017/745 is not proportionate to the devices’ nature and respective (limited) risks. |
| Type of act: Implementing regulation |
| Draft act: Feedback Upcoming |
| Commission adoption: Planned for Fourth quarter 2025 |
Background
As the initiative refers to reclassification, it is presumably invoking Article 51(3(b)) or Article 51(4). This allows the Commission, by means of an implementing act, to initiate reclassification of a device, or category or group of devices.
Electronic IFUs for Medical Devices
Initiative published: HERE
| Summary: The new implementing regulation will allow the issuance of electronic instructions for use for all medical devices intended exclusively for use by healthcare professionals. |
| Type of act: Implementing regulation |
| Draft act: Feedback Upcoming |
| Commission adoption: Planned for Second quarter 2025 |
Background
Under the MDR 2017/745, electronic Instructions for Use (eIFUs) are only allowed for the following types of devices:
- If they are for professional use and use by other persons is not foreseeable:
- Implantable and active implantable devices,
- Fixed installed medical devices and their accessories, and
- Medical devices and their accessories fitted with a built-in system visually displaying the instructions for use.
- For software covered by the Regulation, the instructions may be provided in electronic format by means of the software itself.
In February 2024 the Commission was requested to assess, and possibly expand, the scope of medical devices eligible for eIFUs.
In August 2024 the Commission opened a survey to collect feedback from healthcare professionals on allowing electronic Instructions for Use (eIFU) for all professional use medical devices.
In October 2024 the survey was closed and 87% of respondents stated they would prefer using eIFUs, if available to them.
Requirements to be Met by Notified Bodies
Initiative published: HERE
| Summary: The European Commission plans to establish a new implementing act that will create standardized rules for notified bodies designated under EU medical device regulations. These rules will specify the requirements that these notified bodies must meet. Notified bodies are independent third parties responsible for the assessment and certification of medical devices and in vitro diagnostics. They are designated and regularly monitored by national competent authorities. |
| Type of act: Implementing regulation |
| Draft act: Feedback Upcoming |
| Commission adoption: Planned for Fourth quarter 2025 |
Background
This may address some of the concerns raised by Team Notified Body during the 15 October 2024 MDCG Working Group meeting, which include:
- Staffing challenges, particularly regarding the “employed by” requirement, which limits the ability of notified bodies to utilize qualified personnel based internationally.
- Request to streamline the review process, including eliminating redundant work.
- Reconsider the application of EU 2017/2185, which defines the scope of designation for notified bodies and lists of device codes.
Expert Panel on Orphan & Paediatric Devices
Initiative published: HERE
| Summary: With this implementing act, the Commission intends to set up an additional expert panel in the field of orphan and paediatric devices and update administrative aspects related to the management of the panels. Expert panels provide scientific technical and clinical opinions and advice in support of the implementation of the EU medical devices regulations. |
| Type of act: Implementing decision |
| Draft act: Feedback: Upcoming |
| Commission adoption: Planned for Second quarter 2025 |
Background
The European Medicines Agency (EMA) launched a pilot program for Orphan Medical Devices in August 2024. During the 15 October 2024 MDCG Working Group meeting, the EMA highlighted its focus on paediatric devices within its Article 61(2) and Orphan Device pilots. Additional areas of short- and long-term support for expert panels were also identified in the meeting.
