A summary of July and August 2024 medical device and IVD regulatory developments, including insights on the IVDR transition extension, Eudamed and Swissdamed module roll outs, and more.
This session held by the European Commission Directorate-General for Health and Food Safety (DG SANTE) Unit D.3 – Medical Devices called “State of play of MDR/IVDR implementation” includes the latest view from the EU Commission on timelines, MDCG documents and amended timelines. It specifically summarizes the reasons and MDCG guidance documents supporting the transition to MDR or IVDR.
This document is subtitled “Q&A on practical aspects related to the implementation of the extended transitional period provided for in the IVDR, as amended by Regulation (EU) 2024/1860 of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices, JULY 2024.”
It includes significant Q&A and interpretation for core questions related to the latest MDR/IVDR amendment by Regulation (EU) 2024/1860.
This revision updates interpretation for harmonized standards and state-of-the-art, but also adds considerations on the references to EN ISO 15189 and ISO 14155:2011 and on information and clarification by CEN and CENELEC and their Technical Committees.
This third update of the comprehensive classification guidance now includes a ‘kit’ definition, and new examples for interpretation of Rule 3(a), Rule 4(a), and Rule 5(c).
This one pager published by the European Commission is showing the gradual rollout for EUDAMED in an illustrative overview.
This template for a Notified Body Confirmation Letter is demonstrating the content and information for a formal application in accordance with Section 4.3, first subparagraph of Annex VII of IVDR written by the NB.
This decision is a renewal of the designation for four entities managing the UDI system for the next five years in Europe:
The first module of the Swissdamed medical devices database is now live. The “Actors” module enables economic operators to register online. Registrations can be applied via Swissdamed.
The second module, “Devices,” which will facilitate the voluntary registration of certain medical devices, will go live in several phases. The first release is planned for 2025.
The product registration obligation already set out in the MedDO and IvDO will enter into force in 2026, with the amendment of the MedDO and IvDO planned for autumn this year.
In the EU, Regulation (EU) 2024/1860 amending the EU-IVDR regarding the transitional provisions for certain IVD medical devices was adopted on 13 June 2024 and included the extension of the validity of certain certificates issued under the old legislation until 2027 – 2029.
On 14 August the Federal Council in Switzerland stated that these amendments must also be implemented in Switzerland to avoid any potential supply bottlenecks.
Update of UK’s MHRA guidance on notifications about clinical investigations for medical devices. A section on regulatory advice meetings and a new QSR template have been added.
Update of UK’s MHRA guidance on how to register medical devices intended for the Great Britain and Northern Ireland markets. The reference guides for Account Management and Device Registration reflect changes to the registration system.
The document is updated for certain Australian requirements linked to the Australian Sponsor (Annex 5, page 160).
Revision of Japanese Medical Device QMS requirements related to Ordinance MHLW MO169, the references aligned with ISO 13485:2003 have been fully removed, reflecting the March 2024 shift to solely acknowledge the ISO 13485:2021 amendment (in line with ISO 13485:2016).
FDA has published a FAQ page, where you’ll find answers to the most common questions FDA has received through ldtfinalrule@fda.hhs.gov related to laboratory developed tests (LDTs). The specified timelines for the phaseout policy stages are set for 1-4 years after the publication date of May 6, 2024. The FAQ page will be updated periodically.
On August 23, 2024, the FDA has published final guidance that provides the standards for the electronic submission of De Novo Requests, a timetable for standard establishment, and exemption criteria. FDA will require De Novo Request electronic submissions to be provided as described in the guidance from 1 October 2025.
On August 20, 2024, the FDA has issued final guidance that allows manufacturers to provide user manuals accompanying electronic products in either paper or electronic form. The guidance marks the FDA’s recognition of the wide use of electronic media for instruction provision, and capitalises on the opportunity to reduce paper consumption, increase accessibility, and provide rapid means for editing and updating content.
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