Our MedTech news roundup for July 2024 covers WHO’s announcement of MeDevIS, the EU AI Act, MDCG guidance on medical device standardisation and IVD classification rules, MedTech Europe’s call for industry competitiveness, and the latest on portable battery compliance.
Information sheets from Swissmedic on clinical investigations and performance studies also feature, as well as updates from the FDA, Health Canada, and China’s NMPA on dental devices, recognised standards, and urgent device importation respectively.
Read on for more…
WHO announces MeDevIS platform to boost access to MedTech and devices
This month the World Health Organization (WHO) publicly announced its new online platform, MeDevIS (Medical Devices Information System). As the first global open access clearing house for information on medical devices, the platform is designed to support governments, regulators, and users in their decision-making on selection, procurement, and use of devices.
With the aim to provide a “one-stop-shop of international information”, the MeDevIS platform includes 2,301 types of medical devices used for a broad range of health issues – a figure set to grow as the platform develops.
It references two international naming systems for medical devices – the European Medical Device Nomenclature (EMDN), mostly used in European countries for registration in the European database, and the Global Medical Device Nomenclature (GMDN) used in regulatory agencies in Australia, Canada, the UK, US, and other Member States. The naming systems include coding and definitions and can be used in every country to facilitate registration for regulatory approval, procurement and supply, inventories in health facilities, tracking, and pricing.
Find out more about MeDevIS here.
MedTech news from the EU & Switzerland
EU Artificial Intelligence Act to take effect 1 August
In 2021, the EU Commission proposed a Union-wide regulation on Artificial Intelligence (AI). Following extensive negotiations, the “Regulation laying down harmonised rules on Artificial Intelligence” (AI Act) was adopted by European Parliament and the Council of the European Union, and the act was published in the Official Journal of the European Union on 12 July 2024.
The AI Act takes effect on 1 August this year, and whilst it will be directly applicable in all 27 member states, there is a phased system of transitional periods, along with certain exceptions to the rules concerning implementation date.
Find out more about the AI Act here.
MDCG updates guidance on standardisation for medical devices
The MDCG has updated its guidance on standardisation for medical devices. Released this month, MDCG 2021-5 Rev. 1 incorporates additions relating to EN ISO 15189 and ISO 14155:2011, MDR/IVDR standardisation, rulings of the European Court of Justice, as well as regarding the European Pharmacopoeia, common specifications, and CEN & CENELEC and their Technical Committees.
Updates regarding HAS consultants, the IMDRF, the state of the art, and the SFHS (former ABHS) are also included.
You can access the revised guidance here.
Updated guidance on IVD medical device classification rules under IVDR
This month the MDCG has released revised guidance on the classification rules for in vitro diagnostic medical devices under the EU IVDR. These latest changes affect the following rules:
- Rule 3(a) – Devices intended for detecting the presence of, or exposure to, a sexually transmitted agent
- Rule 4(a) – Devices intended for self-testing
- Rule 5(c) – Specimen receptacles
- Rule 6 – Devices not covered by the above-mentioned classification rules are classified as Class B
You can read the updated guidance here.
MedTech Europe urges EU Commission to prioritise industry competitiveness
As part of its statement of support for the re-election of President Ursula Von der Leyen, MedTech Europe has urged the EU Commission to prioritise the competitiveness of the medical technology industry to benefit patients in Europe.
Whilst acknowledging Europe’s innovative MedTech research ecosystem, efficient and accessible healthcare systems, and move towards value-based healthcare, MedTech Europe noted that the continent’s current political, legislative, and regulatory trajectory prompts hesitation amongst investors.
The organisation called upon the EU Commission to champion policies that ensure equitable access to top-tier healthcare, foster a unified digital health ecosystem across Europe, and build crisis-resilient healthcare systems that are financially and environmentally sustainable. MedTech Europe also encouraged MDR and IVDR reform in their statement, to overcome “inefficient and unpredictable processes, skyrocketing cost of compliance, insufficient support for innovation, and a lack of accountable governance.”
Read MedTech Europe’s full statement here.
Template published for Manufacturer’s Declaration under Regulation (EU) 2024/1860
MedTech Europe has published a Manufacturer’s Declaration template to facilitate compliance with Regulation (EU) 2024/1860.
Any IVD manufacturer may freely use the template to make their own declaration regarding the extended transitional periods for devices for which the conformity assessment procedure under IVDD did not require notified body involvement, the validity of certificates issued under IVDD, and/or the compliance of legacy devices.
Authorised Representatives may also complete the declaration on the manufacturer’s behalf.
Find out more about the template here.
Portable battery compliance required from August
By 18 August this year, portable batteries need to be compliant with the EU Battery Regulation 2023/1542. This means that portable batteries must possess the technical documentation for compliance to relevant articles of the regulation, declaration of conformity, and CE marking.
As such, medical device and IVD manufacturers must review the compliance of their batteries, including ensuring there is the necessary CE marking, or accepting responsibility as the manufacturer and affixing the CE marking.
Swissmedic publishes information sheets on clinical investigations and performance studies
This month Swissmedic has published two information sheets.
The Information Sheet on Clinical Investigations with medical devices and the Information Sheet on Performance Studies with IVD are intended for sponsors of clinical investigations of devices and performance studies with IVDs respectively, as well as CROs and investigators.
Valid under MDR and the IVDR correspondingly, the resources provide guidance on the authorisation process, reporting requirements of sponsors, and Swissmedic’s surveillance.
You can access both information sheets here.
MedTech updates from the US, Canada, & China
FDA shares draft guidance on 510(k) submissions for dental devices and curing lights
The FDA has published two draft guidance documents regarding 510(k) submissions for dental composite resin devices, and dental curing lights (which harden the resin-based materials used in fillings, bonding, and other dental procedures),
The draft guidance documents provide the FDA’s recommendations on device description, performance testing, and labelling to support 510(k) premarket submissions.
You can access each draft guidance document – both of which are open for comments until 10 September, at the respective links below:
- Dental Composite Resin Devices – Premarket Notification (510(k)) Submissions – Draft Guidance for Industry and FDA Staff
- Dental Curing Lights – Premarket Notification (510(k)) Submissions – Draft Guidance for Industry and FDA Staff
Health Canada updates recognised standards guidance
Health Canada has updated its list of recognised standards for medical devices, as well as its guidance on using standards to support compliance with the Medical Device Regulations.
The updated standards list includes a new method of version recognition using standards listed without years and editions, as well as six new standards, and 12 updated standards. 14 standards have also been removed.
The updated guidance document explains the concepts that manufacturers must apply when using standards to support compliance with the Medical Devices Regulations and explains the new method used for version recognition.
China’s NMPA green lights urgent importation and use of certain medical devices
On 19 July the NMPA published “Management for Temporary Importation and Use of Medical Devices Urgently Needed in Clinical Settings”, which green lights the urgent importation and use of medical devices nationwide, even if they have not been NMPA approved.
The management requirements define the product and medical institution scope, clarify the responsibilities of institutions, enterprises, foreign manufacturers, and agents, and specify application materials, procedures, review methods, and timelines. The requirements apply to the temporary importation of Class II and Class III medical devices urgently needed for clinical use, that are already available abroad but not domestically, excluding large-scale equipment.
NMPA releases newly established standards
36 newly established or revised industry standards were released by the NMPA on 10 July, with the aim of guiding manufacturers on the topics of type testing, pre-clinical, clinical studies, and regulatory submissions. Read more about the specific standards here.
That concludes our July 2024 MedTech news roundup. Check back in August for more medical device news and updates.
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