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On 26 March 2026, the European Parliament adopted amendments to a proposed regulation intended to simplify the implementation of EU rules on artificial intelligence (“Digital Omnibus on AI”), amending the EU AI Act (Regulation (EU) 2024/1689). The adopted text states the file was referred back for interinstitutional negotiations under the ordinary legislative procedure (first reading). Selected points highlighted in the amendments Note: this is an adopted European Parliament position at first reading and is subject to further negotiations before any final legal text is agreed. More info, here.

ISO 14155:2026 (published March 2026)  is the updated international standard for Good Clinical Practice (GCP) in clinical investigations of medical devices in human subjects. What’s new (selected changes) Practical implication Teams running or preparing device investigations may want to review whether their CIP/protocol structure, risk documentation, committee charters (data monitoring committee / clinical events committee), and reporting procedures reflect the updated expectations.

The MDCG published MDCG 2025-8 Rev. 1 (March 2026), a guidance document on implementing Master UDI-DI for spectacle frames, spectacle lenses and ready-to-wear reading spectacles as highly individualised devices under the MDR. The guidance clarifies how Basic UDI-DI and Master UDI-DI differ and how they are assigned and linked for these device families. The assignment parameters (triggers) and practical decision trees: More info, here.

On 20 March 2026, the European Commission adopted a Commission Delegated Regulation (C(2026) 1798 final) amending Regulation (EU) 2017/745 (MDR) regarding the list of implantable and Class III devices exempted from the obligation to perform clinical investigations under Article 61(6)(b). Why this matters: The act builds on the MDR concept of well-established technologies (WET)—devices with common and stable designs, well-known safety and clinical performance, and a long history of use on the EU market (criteria referenced in MDCG guidance). What changes: Based on experience with MDR implementation and stakeholder consultation through the MDCG, the Commission expands the list of device types in Article 61(6)(b) that may benefit from a simplified approach (i.e., exemption from conducting clinical investigations), provided: the clinical evaluation is based on sufficient clinical data, and it complies with relevant product-specific Common Specifications (CS), where available. Important clarification: Even when exempt from clinical investigations, manufacturers remain required to plan, conduct and document a clinical evaluation in line with Article 61 MDR. Entry into force: The Delegated Regulation enters into force on the 20th day after publication in the Official Journal of the European Union. More info, here.

On December 2025, FDA published a final (nonbinding) guidance: “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.” It clarifies how FDA assesses RWD quality to determine whether resulting RWE can support regulatory decisions, and it supersedes the 2017 guidance.  The guidance highlights:  A practical note that FDA and industry may need up to 60 days to operationalize the recommendations.   More info here. 

In December 2025, FDA issued the final guidance “Processes and Practices Applicable to Bioresearch Monitoring (BIMO) Inspections.” The document describes FDA’s processes and practices for BIMO inspections and recommends communication practices with regulated parties in advance of, during, and after an inspection. The guidance is nonbinding.   What it covers (high level):  More info here.

On December 2025, DG SANTE published MDCG 2025-10, a guidance document on post-market surveillance (PMS) under the MDR/IVDR.   The guidance describes:  More info, here.

In December 2025, the European Commission proposed a draft Implementing Regulation to amend Annex VII, introducing mandatory maximum timelines and defined “clock-stops” for Notified Body activities under the MDR/IVDR. The objective is clear: increase predictability, streamline processes, and support timely access to medical devices.   Team-NB—the European Association of Medical devices Notified Bodies—welcomes the intent, while cautioning that several elements may be difficult to implement without unintended consequences for quality, capacity, and cost.  Team-NB highlights four recurring risks:   More info, here. 

The FDA’s Office of Combination Products (OCP) has issued final guidance titled “How to Prepare a Pre-Request for Designation (Pre-RFD).”   This guidance is designed to assist manufacturers in obtaining preliminary, non-binding feedback from the FDA regarding a product’s regulatory identity (drug, device, biologic, or combination product) and the appropriate Agency Center (CDER, CDRH, or CBER) responsible for review.   Key Highlights: Why this matters for regulated product developers:  How Instituto Pedro Nunes can support your organisation: More info, here.

In its latest Position Paper (October 2025), MedTech Europe urges regulators and Notified Bodies to adopt a risk-based and proportionate approach to Post-Market Clinical Follow-up (PMCF) activities for medical devices under the MDR 2017/745.  Manufacturers report growing pressure from authorities and Notified Bodies to conduct PMCF clinical investigations for nearly all devices — even long-established, low-risk technologies. MedTech Europe argues that this contradicts the MDR’s intent to align clinical evaluation with risk management and may unnecessarily strain healthcare professionals, patients, and innovation capacity.  Main concerns  MedTech Europe calls for:  A proportional PMCF system ensures safety remains verifiable — without compromising the availability of proven, safe devices.  More info: https://www.medtecheurope.org/resource-library/risk-based-approach-post-market-clinical-follow-up/  At IPN, we help manufacturers design and implement PMCF plans that are data-driven, proportional, and regulator-ready, integrating clinical evaluation, PMS, and risk management effectively.