This month’s roundup includes an update on the EU Commission’s joint implementation plan for IVDR, guidance from the MDCG on SSCPs, EUDAMED updates, as well as news from the FDA, China’s NMPA, and Australia’s TGA. Read on for more…
News from the EU
EU Commission publishes updated joint implementation plan for IVDR
The EU Commission has published a joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
The Joint Implementation Plan is the result of review by the MDCG including the relevant sub-groups, with input from stakeholders. As well as setting the priorities, the Plan will serve as a living document to monitor their implementation. The status and timelines for each item are updated ongoing to reflect the progress of the work. You can download the updated plan here.
MDCG releases guidance on SSCP creation
The MDR requires medical device manufacturers to draw up a Summary of Safety and Clinical Performance (SSCP) for implantable devices and class III devices (other than custom-made or investigational devices). The SSCP is then validated by a notified body and made available to the public via EUDAMED.
The MDCG has released a document to provide guidance on the presentation, content, and validation of the SSCP. Read the guidance here.
EUDAMED update: Updated technical documentation now available
We’ve been keeping up to speed on the progress of EUDAMED since December 2020, when the first module on Actors Registration was released. In October 2021, the second and third EUDAMED modules – regarding UDI / Device registration, and Notified Bodies & Certificates, were made available.
This month, updated technical documentation for the second and third modules has been made available. For more information on the technical documentation for the UDI / Device registration module click here, and similarly for the Notified Bodies & Certificates module technical documentation, click here.
Updates from the US
FDA releases final guidance regarding Safety and Performance Based Pathway
The FDA has published final guidance on performance criteria for the Safety and Performance Based Pathway regarding denture base resins, facet screw systems, surgical sutures, and orthopaedic fracture fixation plates.
The guidance documents provide the FDA’s recommendations on performance criteria to support premarket submissions for each of these medical products in the Safety and Performance Based Pathway.
Under this framework, those planning to submit a 510(k) using the Safety and Performance Based Pathway for these products will have the option to use the performance criteria proposed in the respective final guidance documents to support substantial equivalence, rather than a direct comparison between the performance of the subject device and a predicate device. The recommendations are intended to promote consistency and facilitate efficient review of submissions.
You can access each of the guidance documents via the links below:
- Denture Base Resins – Performance Criteria for Safety and Performance Based Pathway
- Facet Screw Systems – Performance Criteria for Safety and Performance Based Pathway
- Surgical Sutures – Performance Criteria for Safety and Performance Based Pathway
- Orthopaedic Fracture Fixation Plates – Performance Criteria for Safety and Performance Based Pathway
FDA publishes draft guidance on Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
The FDA’s recently published draft guidance is intended to provide recommendations to industry regarding cybersecurity device design, labelling, and the documentation to be included in premarket submissions for devices with cybersecurity risk. The recommendations aim to facilitate an efficient premarket review process and help ensure that marketed medical devices are sufficiently resilient to cybersecurity threats. Access the draft guidance here.
The latest from Asia-Pacific
China: All Class III Devices & IVDs subject to UDI from 1 June 2022
China’s NMPA has announced that Unique Device Identification (UDI) will be implemented with all Class III devices and IVDs, effective from 1 June 2022.
69 high-risk class III devices were included in the UDI application for the First Group of Devices, which started from 1 January 2021. This latest announcement means the remainder of Class III devices and IVDs will now follow suit. Find out more here.
China: 23 Mandatory Standards to be issued in 2022
On 14 April, the NMPA issued the “2022 Medical Device Industry Standards Revisions Plan”. The plan includes 23 mandatory and 93 recommended standards. The Standards Revisions aim to facilitate local type testing and regulatory submission by manufacturers and intend to make Chinese standards more consistent with international standards. Read more here.
China: NMPA & China Health Commission introduce GCP
The NMPA and China Health Commission have released the “Quality Management Practice Specification for Clinical Trials of Medical Devices”, which will be implemented from 1 May 2022.
The “China GCP” covers the entire process of medical device clinical trials, including design, implementation, supervision, inspection, data collection, recording, preservation, analysis, summary, and reporting.
It reflects the latest international requirements, referring to documents from the IMDRF such as MDCE WG/N57 FINAL:2019. The specification also introduces the concept of multi-regional clinical trials in different countries or regions, which facilitates the market access of innovative imported products. Find out more here.
Australia: TGA issues update on 2021 Advertising Code regarding hard copy ads
Australia’s Therapeutic Goods Administration (TGA) has updated advertisers on the transitional arrangements regarding the 2021 Advertising Code, specifically in relation to stock of hard copy ads.
The Therapeutic Goods Advertising Code Instrument 2021 came into effect on 1 January 2022. The 2021 Code repeals and replaces the Therapeutic Goods Advertising Code (No.2) 2018 (2018 Code). A transition period applies until 30 June 2022, during which time advertisers can comply with either the 2021 Code or the 2018 Code. Find out more here.
That concludes our April MedTech news. Check back in May for more updates.
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