MDR

Subscribe to MDR via RSS

Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during May and early June 2026 from the United Kingdom and European Union.

May 2026 saw continued momentum across the European Union (EU) and United Kingdom (UK) toward modernizing and streamlining the regulatory landscape for digital health, with a particular focus on accommodating AI-enabled technologies while reducing unnecessary complexity. A central development was the provisional agreement on the Digital Omnibus package, which seeks to simplify the application of the EU AI Act by clarifying overlaps with sector-specific legislation, deferring key obligations, and introducing more proportionate requirements.

In parallel, regulators on both sides of the Channel are advancing reforms to ensure that medical device frameworks remain fit for purpose in an increasingly software-driven and data-centric environment. In the EU, the activation of key European Database on Medical Devices (EUDAMED) modules marks a major step toward enhanced transparency and traceability, while ongoing discussions on the Medical Devices Regulation 2017/745 (MDR)/In Vitro Diagnostic Regulation 2017/746 (IVDR) revisions highlight a strong policy drive toward simplification and better integration of AI. In the UK, the Medicines and Healthcare products Regulatory Agency’s (MHRA) proposed pre-market reforms and broader thinking on AI regulation signal a shift toward more flexible, lifecycle-based oversight, with greater emphasis on post-market monitoring and innovation support.

Data governance and cybersecurity also remain high on the agenda. Industry and regulators alike are emphasizing the need for coherent, proportionate frameworks that avoid duplication while enabling innovation, particularly in light of expanding AI use cases and global supply chains. Together, these developments reflect a broader trend toward risk-based, innovation-friendly regulation, coupled with increasing expectations around transparency, accountability, and data protection in digital health.

Continue Reading Virtual and Digital Health Digest – June 2026

On 7 May 2026, the European Parliament and Council announced a provisional political agreement on the AI Act portion of the Digital Omnibus package. According to the European Parliament’s press release and the Council’s press release, the agreement aims to make compliance more workable, while maintaining its main provisions and risk-based approach. The agreed text has not yet been published, and the agreement remains provisional pending formal adoption by both institutions, which co-legislators intend to complete before 2 August 2026, the date on which the AI Act’s original high-risk system obligations were due to become applicable.

This blog post sets out what the press release describes as having been agreed, and flags the points most relevant to pharmaceutical and MedTech companies. As we noted in our earlier analysis, the Digital Omnibus on AI Proposal carries significant implications for life sciences companies. We will provide a fuller assessment once the agreed text is available and adopted.

Continue Reading EU AI Act Omnibus: Provisional Deal Announced – Initial Reflections for Life Sciences Companies

On 5 May 2026, the European Commission published an implementing regulation setting new procedural requirements for Notified Body assessments in medical device and IVD conformity assessment procedures (the “Implementing Regulation”). The Implementing Regulation aims to give manufacturers greater certainty in their interactions with Notified Bodies during the initial conformity assessment process and in post-market modifications and re-certifications, as well as aiming to avoid inconsistent practices between Notified Bodies.

To achieve these objectives, the Implementing Regulation sets maximum timelines for Notified Body assessments, provides for standardised rules around quotes by Notified Bodies for carrying out assessments and standardises certain information and verification requirements. The Implementing Regulation also requires each Notified Body to monitor and report on the duration and costs of its assessment activities. Manufacturers will, therefore, have better oversight of the performance of each Notified Body when selecting one to carry out an assessment.

The Implementing Regulation has been developed in response to the inconsistent and divergent interpretation of the procedures for Notified Body assessments under the EU Medical Devices Regulation 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR), which makes the processes unpredictable for manufacturers.

The European Commission had previously published the implementing regulation in draft form in December 2025 and opened a consultation, which closed in January 2026.

Continue Reading EU implements new rules on uniform procedural requirements for Notified Body assessments

Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during December 2025 and early January 2026 from the the United Kingdom, and European Union.

January 2026 saw significant activity as UK and EU authorities advanced major initiatives affecting the use of AI, digital technologies, data governance, and cybersecurity in healthcare and life sciences. Notable developments include EMA’s and FDA joint principles on the use of AI across the medicinal product lifecycle, the European Commission’s call for evidence on the proposed amendments to the Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), proposals to strengthen the EU Cybersecurity Act, and important data protection interventions. In parallel, UK and EU regulators continued to focus on the safe deployment of digital tools in healthcare, including new Medicines and Healthcare products Regulatory Agency (MHRA) guidance on mental health technologies and ongoing work to refine AI governance. These updates, alongside developments in Intellectual Property (IP) and product liability, signal a rapidly evolving regulatory environment that will help to shape digital innovation and compliance expectations throughout 2026.

Continue Reading Virtual and Digital Health Digest – January 2026

On 19 November 2025, the European Commission published two legislative proposals – the Digital Omnibus on AI Regulation Proposal and the broader Digital Omnibus Regulation Proposal (“Proposals”) – as part of a wider initiative to simplify and streamline the EU’s digital regulatory framework. Together, the Proposals introduce targeted but significant amendments across a broad range of instruments, including the EU AI Act (Regulation (EU) 2024/1689), the GDPR (Regulation (EU) 2016/679), the ePrivacy Directive (2002/58/EC), the NIS2 Directive ((EU) 2022/2555), and the EU Data Act (Regulation (EU) 2023/2854).

Continue Reading EU Digital Omnibus: What the Proposed Reforms Mean for Pharma and MedTech

Today, 16 February 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) opened an important consultation seeking views on proposed changes to the recognition of CE‑marked medical devices in Great Britain (GB). The initiative forms part of the UK’s ongoing efforts to refine its post‑Brexit regulatory landscape and ensure continued patient access to safe, effective medical technologies. The consultation invites feedback from a broad range of stakeholders, including manufacturers, distributors, clinicians, procurement bodies, trade associations, regulatory specialists, and patient organisations. It follows the UK government’s response in July 2025 to its consultation on routes to market for medical devices and IVDs, which outlined, among other initiatives, details of a future international reliance scheme – see our previous blog post on this for more information.

Continue Reading MHRA Launches Targeted Consultation on Indefinite Recognition of CE‑Marked Medical Devices

Global manufacturers placing medical devices or IVDs on the EU market are facing a pivotal moment. Our latest advisory sets out details on the most significant reforms to the EU framework since the MDR and IVDR took effect, with particular emphasis on what these mean for international companies. For companies headquartered outside the EU, who already face additional hurdles such as appointing an EU Authorised Representative, navigating EU‑specific labelling and language rules, and registering in EUDAMED, the Commission’s proposed changes represent both a long‑awaited easing of systemic pressures and a clear signal to reassess EU market‑entry strategies.

Continue Reading The EU Medical Device Shake‑Up: What International Companies Should Prepare For

Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during December 2025 and early January 2026 from the the United Kingdom, and European Union.

Continue Reading Virtual and Digital Health Digest – December 2025

Introduction

The European Commission has published its proposals on the amendment of the Medical Devices Regulation 2017/745 (MDR) and In Vitro Diagnostic Regulation 2017/746 (IVDR) (“the proposals”). This marks a pivotal moment for the EU healthcare and MedTech landscape, following a public consultation by the Commission in early 2025 (see our blog here) and a call for evidence in September 2025 (see our blog here). The proposals respond to industry concerns over complexity, cost, and delays which have been substantially hammering the MedTech industry since the implementation of the MDR and IVDR.

The proposals aim to streamline regulatory processes, reduce administrative burden, and enhance predictability, while maintaining patient safety and public health. From adaptive pathways for breakthrough and orphan devices to leaner conformity assessments, stronger notified body (NB) governance, and changes to classification, these changes are designed to future-proof the regulatory framework and foster innovation. For manufacturers, healthcare institutions, innovators, and industry stakeholders, the proposals signal a shift toward a more proportionate, risk-based system that supports timely access to critical technologies without compromising quality.

Below, we have set out an overview of some of the key proposals.  Additionally, while not released with the proposals, the European Commission published a draft Implementing Regulation on certain uniform quality management and procedural requirements for the conformity assessment activities carried out by Notified Bodies – see our separate blog on this here.

The proposals have now been submitted to the European Parliament and Council for review. Once the Parliament and Council have adopted their own positions on the text, there will be negotiations to agree a final text which can be formally adopted by the Council and the Parliament. At this stage, it is challenging to anticipate what would be the result of the political negotiations and unclear when the new rules will start to apply.

A feedback period has been opened, running from 7 January to 5 March 2026. All feedback received will be summarised by the Commission and presented to the European Parliament and Council with the aim of feeding into the legislative debate.

Continue Reading From complexity to clarity: How the EU Commission plans to overhaul the MDR and IVDR

On 12 December 2025, the European Commission published a draft Implementing Regulation (“the Regulation”) on certain uniform quality management and procedural requirements for the conformity assessment activities carried out by Notified Bodies (“NBs”), introducing detailed requirements for NBs operating under the Medical Device Regulations (EU) 2017/745 (“MDR”) and the In Vitro Diagnostic Medical Device Regulations (EU) 2017/746 (“IVDR”).

The recitals describe serious systemic challenges that have emerged since the implementation of the MDR/IVDR and the proposals aim to set out a structured resolution to these challenges. An overview of these proposals is set out below. Overall, the Regulation aims to create a harmonised NB landscape that is predictable, transparent, and fair – supporting patient safety while easing unnecessary administrative burdens for manufacturers. Whether this goes far enough to address the challenges identified will have to be seen.

The Regulation is open for public consultation until 23 January 2026. Once feedback has been reviewed by the Commission, it will be published. The Commission  anticipates adoption of the Regulations in the first quarter of 2026, following which it will be sent to the European Parliament and Council for consideration. The timing of the formal adoption of the Regulation is not yet clear.

Continue Reading A Deep Dive into the EU’s New Implementing Regulation for Notified Bodies