MedTech Regulatory Insights December 2025

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December 8th, 2025
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MedTech Regulatory Insights December 2025

REGULATORY RADAR

MedTech Regulatory, medtech regulatory compliance, medtech regulatory consulting, — MedTech Regulatory Insights December 2025 8

1. MedTech Europe Pushes for Digital Labels

Medtech Europe has published a joint position paper on the Digital label for authorised representative and importer, which urges the European Commission to allow details regarding the EU Authorised Representative and EU importer to be provided digitally, rather than solely on the physical label.

2. Swissmedic Updates SPP Guidance

Swissmedic has published version 1.1 of the Information Sheet on Systems and Procedure Packs (SPP), featuring minor editorial changes and the addition of a notable example in Chapter 4.1: specimen collection kits are considered Procedure Packs.

3. ISO 9001 Revision Advances

The next ISO 9001 revision is expected in October 2026, with the Draft International Standard now open for public comment. While the update includes editorial clarifications to ISO 9001:2015, it introduces a stronger focus on quality culture, ethical conduct and leadership’s role in continual improvement—representing a meaningful shift in the standard. As the organisation leading the revision, support and guidance will be provided to help organisations prepare for a smooth transition.

4. Updated Medical Device Policy Released

The second edition of the Development of Medical Devices Policies updates the 2011 version to align with the Sustainable Development Goals and emerging global health priorities. It adds new content on sustainability, digital health, participatory governance, public health emergencies, and medical device nomenclature. The document also updates regulatory frameworks, HTA and HTM guidance, and emphasises needs-based prioritisation, recent WHA resolutions, and implementation strategies with indicators for monitoring progress.

5. CDSCO Licenses Mandatory for Devices

The notice clarifies that under the Medical Devices Rules, 2017, all medical devices sold in India must have a valid CDSCO or State Licensing Authority license based on their risk class (A–D). Manufacturing and import licenses are mandatory, and no device can be sold without them. Procurement agencies, including hospitals, must require these licenses during tenders. Other certifications, like USFDA/CE, may be additional but cannot replace CDSCO/SLA licensing requirements.

1. FDA Clears Zimmer Biomet’s Enhanced ROSA Knee

Zimmer Biomet received FDA 510(k) clearance for ROSA® Knee with OptimiZe™, an enhanced robotic-assisted knee replacement system offering personalised surgical planning, improved accuracy and reduced variability. The system introduces new planning, landmarking, tracking, kinematic alignment and user-experience features, and integrates with ZBEdge® Analytics for data-driven decisions. Targeted release will begin in 2025, with full U.S. availability expected in early 2026.

2. Biorad Medisys Develops VNS Device

Pune-based medical device maker Biorad Medisys is developing an implantable device that uses vagus nerve stimulation (VNS) to help regulate blood-glucose levels, hunger, and insulin sensitivity, potentially offering a new non-drug approach to managing diabetes and obesity. The innovation is being developed by the company’s newly acquired US-based unit, Reshape Lifesciences, which specialises in obesity and metabolic-focused medical technologies.

1. FDA Issues BD Pump Correction

“Correction Alert” from the U.S. Food and Drug Administration (FDA), announcing that Becton, Dickinson and Company (BD) has updated the instructions for use of its BD Alaris Pump infusion-pump systems because of an identified issue. The alert clarifies that this is a correction (not a removal), but still involves a serious risk — the continued use of affected devices without following the updated instructions may cause serious injury or death.

2. FDA Recalls BALT MEGA Ballast

U.S. Food and Drug Administration (FDA) Recall — BALT USA Removes MEGA Ballast Distal Access Platform.

The FDA has issued a recall alert for the “MEGA Ballast Distal Access Platform” manufactured by BALT USA.
This recall is classified as the most serious type: the devices must be removed from use or sale because continuing to use them “may cause serious injury or death.”
Hospitals, providers and distributors should cease using or distributing the affected devices immediately and follow the FDA’s recall instructions.

3. Baxter Life2000 Ventilation System Recall:

Baxter is recalling all Life2000 ventilators and compressors due to a cybersecurity vulnerability. Unauthorised physical access could alter therapy settings, risking device malfunction, serious injury, or death. Patients and healthcare providers must stop use immediately, contact Baxter or their supplier for replacement therapy, and ensure devices are not left unattended. No injuries or deaths reported to date. For assistance, contact Baxter Home Care (800-426-4224, option 3) or Acute Care (800-426-4224, option 2 → 1).

4. Siemens 3 Tesla MRI Systems Correction Alert:

Siemens Healthineers is issuing a correction for certain 3 Tesla MRI systems due to potential ice blockages in the magnet venting system. If a magnet quench occurs, helium gas may be trapped, causing pressure buildup, possible rupture, massive helium release, cold burns, trauma, or death. No injuries have been reported. If the error message about “average heater power above threshold” appears, stop scanning, remove the patient, secure the room, post “DO NOT USE,” and contact Siemens service (1-800-888-7436). Continue use only after inspection.

5. B. Braun Streamline Bloodline Set Correction Alert:

B. Braun Medical identified damaged arterial and venous connectors in certain lots of the Streamline Bloodline Set for Dialog+, potentially allowing air ingress, blood/fluid leakage, microbubbles, or triggering air-in-line alarms. Risks include treatment delays, moderate blood loss, bloodstream infections, air embolism, and, in severe cases, life-threatening events or death.

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ASK THE EXPERT

Question: As Per IVD kit for screening of Flu includes the following components:

A portable instrument having built-in software for result interpretation

Ready-to-use assay kit

Sample collection & processing kit

In which class shall this medical device be classified as per IVDR? It shall be registered separately or as a single system?

Answer:

The kit and its components are considered a single functional unit for a specific flu screening purpose and are handled as a single device during the conformity assessment process.
Kit Definition: The IVDR defines a “kit” as a set of components packaged together and intended to be used to perform a specific IVD examination.
Component Classification: The individual components have different baseline classifications, but the final system classification governs.
The portable instrument and its built-in software, if it merely drives the instrument and has no independent diagnostic function, would typically be Class A.
The sample collection kit is a Class A specimen receptacle component.
The ready-to-use assay kit components follow the highest risk classification of the intended test (Class C for Flu).
Highest Class Prevails: Implementing rule 1.9 of the IVDR states that if several classification rules apply to the same device or system, the rule resulting in the higher classification shall apply.

Therefore, the entire system is classified as Class C.

TRIVIA

In a Clinical Study Report (CSR) Adverse Event (AE) narrative, what’s the golden rule for describing the event timeline?

Use only the investigator’s description verbatim
Present chronological, medical, and causality context in a neutral tone
Include the sponsor’s interpretation of severity
Summarise only for SAEs

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EVENTS

India Med Expo 2025 – 22nd Edition
India Med Expo Hyderabad 2025 brings together exhibitors and visitors to showcase cutting-edge medical devices, diagnostics, and healthcare solutions.
5–7 Dec | Hitex Exhibition Centre, Hyderabad
Register Here

Medicall Mumbai 2025 – 44th Edition

Medicall is India’s largest B2B Medical Equipment Exhibition

12–14 Dec | Nesco, Goregaon, Mumbai

Medical Expo in India – Medicall – Expo Registration – Visitors/Stalls