The Last Quarter of 2024 in MedTech: It Has Been a Busy Year

By Evangeline Loh

Last year, 2024, was our inaugural year of quarterly regulatory insights: first quarter, second quarter, third quarter . We’ve relished every moment of highlighting medical device regulatory developments. Sometimes the regulatory themes were very natural, other times, the categorization was a little more contrived.

Q4 2024 highlights post-market surveillance (PMS), regulatory revision and clinical investigational data.

Developments in PMS continue

Manufacturers are sometimes required to obtain data on medical devices on the market and in use. PMS is hence so pivotal.

The European regulations (MDR 2017/745, IVDR 2017/746) established the importance of PMS. And, even before then, the medical device regulatory system in Australia leveraged different regulatory authorizations, though the Therapeutic Goods Administration (TGA) focused on market surveillance and a manufacturer’s PMS.

The Dutch authorities surveilled the PMS of 13 Dutch manufacturers. The results (October 8) were grim: each manufacturer was deficient. The UK Medicines and Healthcare Regulatory products Agency (MHRA) posted a draft Statutory Instrument (SI) on PMS. And, on December 20, MHRA released the official SI on PMS, Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (SI 2024 No. 1368) heralding the focus on compliance to this PMS SI on June 16, 2025.

Regulatory revision

There has been a tremendous amount of discussion about structural revisions to the European MDR and IVDR while the European Commission continues their survey on the MDR and IVDR.  

In China, there was a draft Medical Device Management Law to revolutionize the current state order. This is proposed to increase the magnitude of the legislation while simultaneously removing administrative burdens and the requirement for a medical device to be authorized first in the country of origin.

In the UK, the MHRA revised (December 11) the initial roadmap posted in January. In addition to development in four policy areas and four future software guidance documents, the pre-market SI, public consultation commenced November 14, and is expected to come into force in 2026.

Clinical investigational data

The 2024 Medica conference in Düsseldorf showcased innovation. It seems that our future revolves around sensors capturing data and assessing the data to share analytics, insights and clinical decisions. Even our vehicles may become medical devices in the future. Big data is a part of this, though we’ll likely need clinical investigation data to support this.

In Europe, MDCG 2024-15 was released (guidance on clinical investigational reports (CIR) in the absence of EUDAMED). CIRs for medical devices are now posted to CIRCABC. The regulator in Brazil, ANVISA, shared a database (December 19) of higher-risk medical device clinical investigations starting from 2016. The proposed Medical Device Management Law advances global Randomized Controlled Trials (RCT) and the use of RCT data for registration in China.

Concluding remarks

The International Medical Device Regulators Forum (IMDRF), currently under the U.S. Food and Drug Administration (FDA) chair, emphasized regulatory reliance, as many developments this year advanced this theme. The popular press and even regulators discussed artificial intelligence (AI), but thus far only the European Union has established legislation (the AI Act) to address this issue.

We look forward to 2025, sharing regulatory news and continuing to write about the importance of regulatory reliance, clinical investigational data and PMS.