Our August MedTech news roundup covers the EU Commission’s call for EURLs, an FAQ from Swissmedic on medical devices notification, MDCG guidance regarding notified bodies and joint assessment teams, plus new technical documentation on UDI/Devices registration. Guidance from the FDA is also included – regarding hearing aids and hydrogen peroxide-based contact lens care products respectively, as well as an update from Australia’s TGA on active medical devices. Read on for more…
EU Commission calls for EU reference laboratories
According to Article 100 of the EU IVDR, the European Commission may designate EU reference laboratories (EURLs) for high-risk in vitro diagnostic medical devices.
As such, this month the Commission has called upon EU Member States, as well as Iceland, Norway, Liechtenstein and Turkey to submit applications for candidate EURLs.
Member states have until 31 March 2023 to submit their nominations to the Commission. Find out more here.
Swissmedic shares FAQ on medical devices notification
Swissmedic has published Frequently Asked Questions regarding the notification of medical devices. Topics covered in the FAQ include what medical devices must be notified to Swissmedic, who must submit the notification, which class of devices should be notified to Swissmedic, EUDAMED access, information on device codes, and costs and timings for notifications. Read the full FAQ here.
MDCG shares guidance on designation, re-assessment and notification of conformity assessment bodies and notified bodies
MDCG 2022-13 provides guidance to the authorities responsible for notified bodies and joint assessment teams for when they:
- conduct assessments of CABs (conformity assessments bodies) that apply for designation as a notified body in the field of medical devices and/or IVD medical devices
- re-assess notified bodies (NBs)
The MDCG guidance published this month aims to bring consistency and alignment to the working practices of the different designating authorities in the Member States, regarding the assessment, designation, notification and re-assessment of CABs and NBs. You can access the guidance here.
EU commission releases technical documentation on UDI / Devices registration
On 2 August, the EU commission released Version 2.8 of their Technical Documentation (TD) regarding UDI / Devices registration. The TD includes a EUDAMED UDI / Device data dictionary, UDI Device business rules, UDI Device enumerations, the DTX service definitions for economic operators, a data exchange user guide for economic operators, and EO-XML samples. Take a look at the documentation here.
FDA updates regulatory framework for hearing aids
The FDA is establishing a regulatory category for over-the-counter hearing aids and making related amendments to update the regulatory framework for hearing aid devices. In doing this, the FDA intends to provide reasonable assurance of safety and effectiveness for these devices as well as foster access to, and innovation in, hearing aid technology, thereby protecting and promoting public health.
With the final rule effective from 17 October 2022, the FDA has this month released final guidance on regulatory requirements for hearing aid devices and personal sound amplification products (PSAPs). The guidance describes hearing aids, PSAPs, their respective intended uses, and the regulatory requirements that apply to both types of products.
You can access the final guidance here and read more about the FDA final rule on Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids here.
FDA issues draft guidance on hydrogen peroxide-based contact lens care products
The FDA has issued draft guidance to provide labelling recommendations for hydrogen peroxide-based contact lens care products (HPCPs) submitted in premarket notification (510(k)) submissions.
Misuse associated with these devices has resulted in serious eye injuries, and so the labelling recommendations in this guidance aim to help manufacturers to develop labelling with information about specific risks and directions for use of HPCPs in conjunction with a user’s prescribed contact lenses. The draft guidance is open for comments until 17 October 2022, and is available to read here.
Australia’s TGA publishes requirements overview for active medical devices
Active medical devices are a subset of devices that use energy to operate. The TGA has recently published an introduction and overview of requirements that cover guidance on the specifics relating to these devices, which include the likes of pacemakers, gas-powered suction pumps, X-ray machines, surgical lasers and lung ventilators. Read more on the guidance here.
That concludes our August MedTech news. Check back in September for more updates.
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