Our February 2024 MedTech news roundup covers the latest information from the MDCG on EMDN update procedures and the vigilance system for CE-marked devices respectively, as well as news from the EU Commission on the extra steps proposed to ensure availability of medical devices and the results of its latest Notified Bodies Survey on certifications and applications related to MDR and IVDR.
Read on to also find out more about the launch of the UK’s “Team-AB”, the release of version 2.0 of the NIST Cybersecurity Framework, and new guidances from Health Canada and China’s NMPA.
MDCG shares procedures for the updates of the EMDN
This month the MDCG released information regarding the procedures for the updates of the European Medical Device Nomenclature. MDCG 2024-2 details the actors involved, the procedure for the annual revision of the EMDN, and the pilot procedure for the ad-hoc updates of the EMDN requiring an expedited review. You can access the document here.
MDCG publishes guidance on vigilance system for CE-marked devices
The MDCG has released Device Specific Vigilance Guidance (DSVG) to harmonize vigilance reporting and provide guidance for manufacturers of specific devices. Whilst the guidance provides further clarification for vigilance reporting of specific devices to the relevant Competent Authority, it does not replace or extend any of the requirements in MDR or IVDR.
The document outlines how to report incidents and serious incidents, defined in Article 2(64) and (65) MDR and in Article 2(67) and (68) IVDR, in accordance with Articles 87 and 88 MDR and Articles 82 and 83 IVDR, which occurred with specific devices to the relevant Competent Authority. Read the guidance here.
EU Commission proposes extra steps to ensure availability of medical devices
At the end of last month, the EU Commission proposed additional steps regarding the transition period for IVDs, the EUDAMED rollout, and an information obligation in case of interruption of supply. The Commission’s proposal includes:
- Allowing more time for IVD manufacturers to transition to the new rules, subject to certain important conditions
- Speeding up the launch of some parts of the European Database on Medical Devices (EUDAMED)
- Obliging manufacturers to notify in case of supply disruption of certain devices
The proposed steps aim to ensure the availability of in vitro diagnostics, enhance transparency, and safeguard patient care. Find out more on the proposal here.
EU Commission shares results of Notified Bodies Survey on certifications and applications
The EU Commission has released the results of its latest Notified Bodies Survey on certifications and applications related to MDR and IVDR. The survey is part of the Commission’s ongoing study to support the monitoring and analysing of medical device availability on the EU market, and these latest results collected are from the sixth Notified Body survey that captured data up until 31 October 2023.
The results revealed an indication from the majority of Notified Bodies that less than 25% of their clients have completed the transfer of all devices intended to be certificated to MDR, with only four Notified Bodies indicating that over 50% of their clients have completed the transfer. Almost all Notified Bodies indicated that less than 25% of their clients have completed the transfer to IVDR. You can access the full results here.
UK approved bodies launch Team-AB
On 19 February, a group of approved bodies in the UK came together to launch the UK Association for Medical Device Approved Bodies (Team-AB). With plans to lobby the government and the MHRA as new medical device regulations are developed in the UK this year, the group intends to act as a forum for applicant and designated approved bodies to share their experiences about the UK’s regulatory regime.
The current UK Medical Device Regulations 2002, based on the EU Medical Device Directives (MDD), is set to undergo a major update that’s expected to come into effect in 2025. As such, the group hopes to develop a more consistent understanding of what regulators expect of them and the feedback they give to stakeholders as the UK regulatory landscape is reformed.
Read more on this in the RAPS article here.
UK’s MHRA lists two new approved bodies
The MHRA has listed two new approved bodies under the UK Medical Devices Regulations. LNE-GMED UK Limited and Scarlet NB UK Ltd have been added under the medical devices scope. For more information on the UK approved bodies, see here.
NIST releases version 2.0 of Cybersecurity Framework
The National Institute of Standards and Technology (NIST) has released the updated 2.0 edition of its Cybersecurity Framework (CSF). The update to this essential guide for managing cybersecurity risk is designed to make the framework universally applicable, catering to a diverse range of industries (including MedTech), organisation sizes, and cybersecurity maturity levels. Read more on this here.
Health Canada publishes updated draft guidance on interpreting ‘significant change’
Health Canada has published draft guidance on how to interpret the definition of “significant change” of a medical device.
The guidance document has been updated to expand on the definition of “significant change” in the Medical Devices Regulations to help medical device manufacturers determine whether a change proposed to a Class III or IV medical device is significant. Read more about the guidance here.
China’s NMPA publish final guideline facilitating international access to real world data pilot
NMPA recently published the finalised document “Guideline on Medical Device Real-world Study Design and Statistical Analysis”. The guideline will facilitate overseas manufacturers to further explore the Hainan Real-world Data pilot program.
Hainan Boao Pilot Zone allows overseas unapproved medical devices, IVDs, and drugs with clinical urgency status to be used in China. While commercializing and selling their products, manufacturers can collect RWD through RWS in Hainan as local clinical evidence in China to support their national NMPA registration approval, which may reduce the timeline for market access. Find out more here.
That concludes our February MedTech news roundup. Check back in March for more medical device news and updates.
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