Database for In vitro diagnostics Medical Devices notification | 25 April 2023
In Vitro Diagnostic Medical Devices Notifications includes notifications on the first placing of in vitro diagnostics on the market (according to § 25 MPG – Act on Medical Devices).
The database is part of the German database-supported medical devices information and database system. Included therein is mainly administrative data and further data relevant to the notification.
Electronic submissions for medical devices will be opened on 2nd May | 06 April 2023
Fimea’s new electronic submission service will be opened for medical device operators on 2 May 2023. The electronic submission service is used for reporting data to the national CERE register by
- Self-manufacturers of social welfare and health care units,
- Manufacturer of custom-made devices, excluding manufacturers of risk class III implantable devices (notified body used in the assessment), and
- Distributors liable to file a notification.
UNITED KINGDOM (UK)
Software and Artificial Intelligence as a medical device | 06 April 2023
AI and software play a crucial role in health and social care. Numerous of these items are governed as medical devices or in vitro diagnostic medical devices (IVDs) in the UK.
Access to significant Software Group outputs that may be useful is provided in this guidance. Click here to download the guidance on Software as a Medical Device (SaMD), including Artificial Intelligence as a Medical Device (AIaMD)
Guidance for manufacturers on vigilance | 24 April 2023
The medical device vigilance system involves reporting and evaluating adverse incidents and safety corrective actions related to medical devices.
This system is described in detail in the MEDDEV 2.12/1 rev 8 guidelines and additional guidance on post-market surveillance, which provide information on what incidents to report, how to report them, and when to do so for medical devices on the UK market
Register medical devices to place on the market | 27 April 2023
Before being sold in Great Britain (England, Wales, and Scotland), all medical devices, including IVDs, custom made devices, or procedure packs, must be registered with the MHRA.
To be sold and registered with the MHRA, devices in Great Britain must comply with the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002), which are in effect there.
Only manufacturers or UK Responsible Persons with a physical presence in the UK, or Northern Ireland-based Authorized Representatives (for the purposes of the Northern Ireland market), may register devices with the MHRA.
Implementation of medical device future regime | 27 April 2023
The MHRA released the government’s response to the public consultation on the future oversight of medical devices in the UK on June 26, 2022.
The response described the planned regulatory reform, as well as the transitional plans for CE and UKCA marked devices sold in the United Kingdom. an update on the timelines to implement the future Medical Device Regulations can be found here (Implementation of medical devices future regime)
Regulating medical devices in UK | 28 April 2023
The UK medical device market is governed by the Medicines and Healthcare Products Regulatory Agency (MHRA). This guidance provides information on the UK system, including for:
- Getting your device certified
- Conformity marking your device.
- Registering your device with the MHRA
This guidance is divided into sections on the different rules that apply in Great Britain, Northern Ireland and the EU. Great Britain is England, Wales and Scotland.
Extended acceptance of CE marked medical devices on the Great Britain market | 28 April 2023
An extended timeframe for the acceptance of CE-marked medical devices on the British market has been made possible by a statutory instrument that has been laid before Parliament.
This means that subject to parliamentary approval, medical devices with the CE mark will be accepted on the British market after the current deadline of 30 June 2023.
Announcements on clinical trial with medical devices and performance studies with In vitro medical devices | 13 April 2023
The instructions for submitting combined trials and for submitting previously authorized trials that are now being converted to combined trials have been updated by SwissMedic.
UNITED STATES OF AMERICA (USA)
Agency Information Collection Activities | 10 April 2023
The Food and Drug Administration (FDA) is making the public aware of an opportunity to comment on the Agency’s proposed collection of specific information.
Federal agencies are required to publish notice in the Federal Register under the Paperwork Reduction Act of 1995 (PRA). regarding each proposed data collection, including any proposed extensions to already-existing data collections, and to give the public 60 days to respond to the notice with comments.
In this notice, the Centre for Devices and Radiological Health of the FDA is seeking feedback on the information gathering related to reports of removals and corrections for medical and radiation emitting products.
Sterilization for medical devices | 11 April 2023
The Radiation Sterilization Master File Pilot Program has been announced by the FDA. This voluntary pilot program aims to assist businesses in developing less onerous regulatory methods for sterilizing approved medical devices, including new radiation sources.
Under the specific conditions outlined in the notice, the pilot will be accessible to nine companies that sterilize single-use, PMA-approved medical devices using gamma radiation or ethylene oxide (EtO) and intend to submit master files when making certain changes to sterilization sites, sterilization methods, or other processes.
Guidance for Industry and Food and Drug Administration (FDA) Staff | 13 April 2023
The Food and Drug Administration (FDA) has released a final guidance document titled “Peripheral Percutaneous Transluminal Angioplasty and Specialty Catheters-Premarket Notification (510(k)) Submissions“.
The FDA is releasing this final guidance document to offer suggestions for 510(k) submissions for specialty catheters and peripheral percutaneous transluminal angioplasty (PTA) balloons.
At-Home OTC COVID-19 Diagnostic Tests | 17 April 2023
The FDA has provided information on at-home over-the-counter (OTC) COVID-19 diagnostic tests, which are authorized for self-testing. These tests allow individuals to collect their own sample, perform the test, and read the result without needing to send a sample to a laboratory.
There are two types of diagnostic tests available: molecular and antigen, with most authorized at-home OTC COVID-19 tests being antigen tests.
However, users of antigen tests should repeat testing following a negative result, whether they have symptoms or not, to reduce the risk of a false negative test result. For more information, the FDA has issued a safety communication on the matter.
In Vitro Diagnostic Devices for Detection and/or Diagnosis of Ebola | 19 April 2023
The Food and Drug Administration (FDA) has announced the revocation of Emergency Use Authorizations (EUAs) previously issued to BioFire Defense, LLC, and Biocartis NV.
The FDA revoked the EUAs for the FilmArray NGDS BT-E Assay and the Idylla Rapid Ebola Virus Triage Test under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as requested by each Authorization holder.
In Vitro Diagnostics EUAs – Molecular Diagnostic Tests for SARS-CoV-2 | 19 April 2023
The Food and Drug Administration (FDA) has released two final guidance to transition from COVID-19 policies to normal operations for medical devices.
The guidances provide recommendations for developing a transition implementation plan, submitting a marketing submission, and taking other necessary actions.
Manufacturers seeking marketing authorization should start working on a submission and transition plan. The Food and Drug Administration (FDA) encourages stakeholders to review the guidance, attend the webinar, and reach out with any questions or concerns.
Orthopaedic and rehabilitation devices panel of the medical devices advisory committee meeting announcement | 20 April 2023
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee.
The committee’s primary responsibility is to advise and counsel the Agency on Food and Drug Administration (FDA) regulatory matters. The public is welcome to attend the meeting.
TIME: From 9 a.m. to 6 p.m. Eastern Time on April 20, 2023, a virtual meeting will be held.
Disclaimer: Regulations/legislations are subjected to changes from time to time and the author claims no responsibility for the accuracy of information.