This month’s roundup covers MedTech updates from the EU & Switzerland, the latest guidance and resources published by the FDA, and news from China’s NMPA. Read on for more…
Updates from the EU & Switzerland
Swiss Medtech calls for urgent changes to national Medical Devices Ordinance
The Swiss Medtech conference in Bern this month addressed how the Swiss MedTech industry is coping since being downgraded to third country status six months ago. In their recent article, the organisation says the industry is well positioned to continue exporting medical products under the new EU regulation, but the current imports situation is cause for concern in terms of posing a risk to patient care. Find out what Swiss Medtech has to say about exports, imports and the future of relations with the EU here.
EUDAMED latest: Two more modules released
We’ve been keeping up to speed on the progress of EUDAMED since December 2020, when the first module on Actors Registration was released. As of this month (October 2021), the second and third EUDAMED modules – regarding UDI / Device registration, and Certificates & Notified Bodies, have also been made available.
According to MDR, the EU Commission is unable to mandate the use of the released modules until EUDAMED is fully functional, so for now, data entry into the system by Economic Operators and Notified Bodies is voluntary. Once EUDAMED becomes fully functional, the remaining modules, as well as the mechanism for scrutiny and the CECP will be released. Find out more here.
EU Commission proposes changes to transitional provisions for certain IVD devices
The EU commission has proposed a progressive roll-out of the new IVDR to prevent supply disruption by changing transitional provisions.
The length of the proposed transition period depends on the type of device. Higher risk devices such as HIV or hepatitis tests (Class D) and certain influenza tests (Class C) have a transition period until May 2025 and 2026, whilst those with lower risk such as Class B and A sterile devices have until May 2027. Read more here.
MDCG publishes guidance on classification of medical devices
The MDCG has published guidance on the classification of medical devices. MDCG 2021-24 covers the purpose of medical device classification, the practical relevance of classification, how to carry out classification, and an explanation on individual rules such as those relating to non-invasive, invasive, and active devices. You can access the guidance here, and if you’re interested in further information regarding how to classify a medical device in the EU, take a look at our fact sheet here.
MDCG shares Q&A on requirements relating to Notified Bodies
The MDCG has released a Questions and Answers on requirements relating to Notified Bodies under MDR and IVDR.
The issues covered in the document have been identified in the context of joint assessments and include organisational and general requirements, resources requirements and process requirements. You can read the Q&A here.
The latest guidance and resources from the FDA…
Draft guidance on select updates for UDI
The FDA has developed a draft guidance for labellers of class I devices to revise the 2020 UDI Compliance Policy Guidance issued on 1 July, 2020. Once finalised, the updates in Section III of this draft guidance will supersede the recommendations in Section III of the 2020 UDI Compliance Policy Guidance.
The draft guidance explains that the FDA does not intend to enforce the Global Unique Device Identification Database (GUDID) submission requirements for certain class I devices, and is open for comments until 13 December 2021. Access the guidance here.
Final guidance on De Novo Classification Process
The FDA’s final guidance on the process for the submission and review of a De Novo classification request under section 513(f)(2) of the FD&C Act, regarding the Evaluation of Automatic Class III Designation is now available. You can access the guidance here, and for more information on the De Novo classification process, download our fact sheet.
Draft guidance on hearing aids and PSAPs
The draft guidance document identifies the applicable legal requirements under the FD&C Act for hearing aids and personal sound amplification products (PSAPs). Whilst hearing aids and PSAPs both affect a user’s ability to hear sound, the products have different intended uses and as such, are subject to different regulatory controls. This guidance aims to tackle the confusion between hearing aids and PSAPs, by describing the products, their respective intended uses, and the regulatory requirements which apply to each. Read the guidance here.
Cybersecurity Awareness Month resources
October was Cybersecurity Awareness Month. Cybersecurity relating to medical devices is an important part of patient safety and so maintaining strong cybersecurity is critical throughout the lifecycle of a device. The FDA has produced several resources as part of this awareness drive, to help educate on cybersecurity issues. Take a look at their cybersecurity awareness activities and resources here.
And in news from Asia-Pacific…
China’s NMPA releases Clinical Evaluation & Clinical Trial Guidelines for IVDs
“Clinical Evaluation Guideline for In Vitro Diagnostic Reagents Listed in Catalog of Clinical Trial Exemption” and “Clinical Guideline for In Vitro Diagnostic Reagents” were published by the NMPA on 24 September and 27 September respectively. The guidelines cover both IVDs exempted from clinical trial, and those undergoing clinical trial. Find out more here.
That concludes our October MedTech news. Check back in November for more updates.
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