Guidance on Surveying, Leveling, and Alignment Laser Products

FDA has issued guidance summarizing its current views on how laser performance standards apply to specialized surveying, leveling, and alignment (SLA) laser systems. While the guidance does not replace the existing standards, it clarifies how manufacturers should interpret FDA requirements for SLA laser products regulated as radiation‑emitting electronic devices. The document also addresses common questions about what qualifies as an SLA laser under FDA jurisdiction.

Classification of Digital Therapy Device for Sleep Disturbance in Psychiatric Conditions

FDA has assigned class II status, with special controls, to digital therapeutic devices intended to reduce sleep disturbances associated with psychiatric disorders. The agency determined that these special controls provide sufficient assurance of safety and effectiveness while supporting patient access to innovative digital health tools.

Classification of Optical Camera‑Based Physiological Monitoring Systems

FDA has classified hardware and software systems designed to measure pulse rate, heart rate, breathing rate, and respiratory rate using optical camera technology as class II devices subject to special controls. This classification reflects FDA’s conclusion that the controls will adequately manage risks and promote access to beneficial monitoring technologies.

Classification of Resorbable Shoulder Spacer

FDA has designated resorbable shoulder spacers as class II devices with associated special controls, which will be incorporated into the formal classification language.

Classification of EEG‑Driven Upper Extremity Powered Exerciser

FDA has placed EEG‑controlled powered exercise equipment for upper limbs into class II with special controls, acknowledging that the control measures will ensure appropriate safety and performance.

Classification of Virtual Reality Behavioral Therapy Device for Pain Relief

FDA has classified VR‑based behavioral therapy systems intended for pain management as class II devices with special controls. These requirements form part of the official regulatory classification for these products.

Classification of Brain Stimulation Programming Planning Software

Software designed to support planning for brain stimulation procedures has been classified by FDA as a class II device with accompanying special controls.

Classification of Bone Indentation Device

FDA has assigned class II status to bone indentation measurement devices, establishing special controls as part of the device’s regulatory classification.

Classification of Implantable Post‑Surgical Kinematic Measurement Knee Device

FDA has classified implantable devices used to measure knee kinematics following surgery as class II devices with special controls.

Updated Guidance on Manufacturer’s Certificate to Export (MCE)

Health Canada has released updated guidance describing how manufacturers can apply for an electronic MCE. The guidance includes instructions for validating medical device licenses and authorizations before submitting an application, as well as steps to confirm the legitimacy of issued certificates.

Annual Summary of Devices Requiring Clinical Evaluation Consultation (CECP)

Under MDR Article 54, notified bodies must seek independent expert panel input through the Clinical Evaluation Consultation Procedure (CECP) for certain high‑risk products, including class III implantables and class IIb active devices that deliver or remove medicinal products. CECP provides expert scientific review of a notified body’s clinical evaluation assessment report.

Pilot Program for Expert Panel Scientific Advice

EMA is initiating a pilot to allow manufacturers of selected high‑risk devices—specifically class III and certain class IIb devices—to obtain scientific advice on clinical development plans and proposed investigations. Starting late February, the agency will accept letters of interest from companies seeking participation.

NIS2 Directive and Medical Device Sector Implications

Directive (EU) 2022/2555 strengthens cybersecurity requirements across the EU, replacing the original NIS Directive. Within the medical device sector, the directive applies to manufacturers of medical and IVD devices, pharmaceutical R&D entities, manufacturers of pharmaceutical products, and manufacturers of devices deemed critical during public health emergencies.

MDR/IVDR Notified Body Designation Code Coverage – Jan 2023

MDR Code Coverage:

• Over 80% of MDR codes are covered by at least 20 of the 36 notified bodies.
• Five codes have coverage from fewer than one‑third of notified bodies:>/li>
• • MDA 0102, MDA 0104, MDA 0103, MDA 0101, MDS 1002.

IVDR Code Coverage:

• More than 80% of IVDR codes are covered by at least 7 of the 8 notified bodies.
• Only one code (IVD 4010, related to mycology) is covered by 5 notified bodies.

MDCG 2023‑2 – Standard Fees Publication Requirements

MDCG clarified that “publicly available” fee information must be directly accessible on a notified body’s official NANDO‑listed website, without registration or additional steps. Fee tables must use the currency of the NB’s country and indicate any regional variations.

EMA Pilot for Expert Panel Scientific Advice for High‑Risk Devices

EMA will launch a pilot in February 2023 enabling manufacturers of class III and class IIb devices that administer or remove medicinal products to request scientific advice from expert panels. Further details on submission templates, timelines, and selection criteria will be provided before launch.

MDCG 2023‑1 – Guidance on Health Institution Exemption (Article 5(5))

New MDCG guidance outlines how MDR/IVDR requirements apply to devices made and used internally by EU health institutions. Article 5(5) establishes conditions under which such in‑house devices are exempt from broader MDR/IVDR obligations. The guidance supports consistent interpretation by national authorities and helps healthcare professionals and researchers understand applicable requirements.

Proposed Amendments to MDR/IVDR Transitional Provisions

The European Commission has proposed updates to the MDR and IVDR transitional rules to ensure continued device availability and maintain high standards of quality, safety, and performance. The goal is to strengthen conformity assessment while preventing disruption caused by expiring certificates under the previous Directives.

Notification Requirements for In‑House Manufactured IVDs (Art. 10 IvDO)
Swissmedic has updated its notification form for devices manufactured and used within healthcare institutions under Art. 10 IvDO. Multiple devices with the same class and EMDN code may be grouped into a single notification if accompanied by a detailed device list. A fee of CHF 300 applies per notification.

Managing Certification Gaps (MDCG 2022‑18)
Swissmedic adheres to EU‑aligned medical device regulations. MDCG 2022‑18 provides a unified approach for managing cases where a device’s MDD/AIMDD certificate expires before MDR certification is issued, creating a “certification gap.” Article 97 MDR allows competent authorities to require manufacturers to resolve non‑compliance within a defined timeframe when no unacceptable safety risk exists, ensuring continuity of device availability.