UK Updates
Medicines & Healthcare products Regulatory Agency (MHRA) MHRA Invites Feedback on Proposed Changes to Medical Device Regulation
On 11 May 2026, the Medicines and Healthcare products Regulatory Agency (MHRA) published new draft pre-market regulatory requirements for medical devices and in vitro diagnostic (IVD) devices entering the Great Britain market.
The draft Medical Devices (Amendment) Regulations 2026 aims to prioritise patient safety and access to innovative medical technologies.
Key highlights:
These measures support the UK’s ambition outlined in the Life Sciences Sector Plan,to become one of the top three fastest countries in Europe for MedTech access by 2030,
Call for Engagement
The MHRA is inviting feedback from industry, approved bodies, healthcare organisations and patients. Stakeholders are invited to share their views via the MHRA survey by 11:59 pm (UK time) on Friday, 19 June 2026. Submitted responses will shape the Impact Assessment and future implementation.
To read more visit : MHRA invites views on proposed changes to medical device regulation - GOV.UK
Understanding the 2026 UK Medical Devices Amendment Regulations
The MHRA has released a comprehensive impact questionnaire to capture insights from manufacturers, healthcare organizations, approved bodies, UK Responsible Persons, and patients.
Impact of questionnaire
The questionnaire published in May 2026 is not just about data collection exercise it is a strategic tool for policymaking. It seeks detailed input on:
What’s Changing Under the 2026 Regulations?
The proposed reforms touch nearly every aspect of the medical device lifecycle. Key areas include:
Economic and Operational Impact
One of the most critical aspects of the questionnaire is its focus on cost implications. Stakeholders are asked to estimate:
Impact on Innovation
A central question is whether the regulations will encourage or hinder innovation.
Patient Safety
At its heart, the reform is about improving patient outcomes. Stakeholders are asked to estimate:
Enhanced traceability, stricter classifications, and better post-market surveillance are expected to reduce risks and improve accountability.
The survey, open from May 11 to June 19, 2026, provides a structured way for everyone including patients to influence the future of medtech regulation in Great Britain.
For guidance visit :https://lnkd.in/ghhvbEec
Medical Devices (Amendment) Regulations 2026
The UK government has laid the Medical Devices (Amendment) Regulations 2026 before Parliament. These regulations update definitions, technical documentation, conformity assessment, software change control, and transitional arrangements to strengthen patient safety, increase clarity for industry, and better align with international practice.
Expanded Definitions
The regulations clarify several core concepts:
Technical Documentation & Inspections
Manufacturers must maintain searchable, English language technical files based on Annex II MDR. Implantable devices must be supplied with implant cards and patient leaflets detailing identification, warnings, and materials. Documentation must be retained for 15 years for implantables and 10 years for other devices. Regulators can request documentation within three working days, reinforcing audit readiness.
Software & PCCPs
The regulations introduce Pre Determined Change Control Plans (PCCPs) for software driven devices. Approved bodies may approve PCCPs with conditions or restrictions, and certificates must reference them to ensure traceability of software modifications.
Conformity & Equivalence
Equivalence claims must consider technical, biological, and clinical characteristics. For Class IIb and III implantables, equivalence requires valid UKCA, CE, or international reliance certificates. Documentation must be retained for the device’s lifetime.
Labelling & Claims
Misleading or unsubstantiated claims in labelling, instructions, or promotional materials are prohibited. Implant cards and patient leaflets are mandatory, improving transparency and patient empowerment.
Transitional Provisions
Manufacturers can continue lawful supply under existing certificates for limited periods:
Applications submitted before cut off must be resolved within 12 months or reassessed under the new rules.
Implications
Conclusion
The 2026 amendments tighten definitions, shorten transitional timelines, mandate implant cards and patient leaflets, and strengthen conformity assessment. These changes reinforce patient safety and accountability while giving industry transitional time to adapt.
For guidance visit :https://lnkd.in/ghhvbEec
UK Export Rule for Drugs and Medicines
The UK has a strong system for export of drugs and medicines, designed to balance patient safety, regulatory oversight, and international trade requirements. Updated in May 2026, this guidance outlines the permissions, certificates, and processes that exporters must follow.
Key categories
Export certificates for human medicines
There are five main certificate types for human medicines. These are
Applications are submitted via the MHRA portal or by email.
Export certificates for veterinary medicines
The VMD issues five Defra certificate :
Applications are made online or by email. Certificates issued within 10 days;
Fees
Great Britain (£54) and Northern Ireland (£30). Fees are paid through GOV.UK Pay.
Exporting drugs and medicines from the UK requires coordination with multiple authorities which are the Home Office, MHRA, VMD, and the Department for Business and Trade. For guidance read more
European Updates
EUDAMED Release 2.27.0
The European Commission has published the latest EUDAMED release notes (v2.27.0, 2026), introducing new functionalities and developments across multiple modules. This update reflects the EU’s ongoing commitment to improving regulatory oversight, transparency, and efficiency in medical device management under the MDR/IVDR framework.
Importance
The EUDAMED release strengthens traceability, compliance, and transparency within the EU regulatory ecosystem.
Key Highlights from the Release
Conclusion
EUDAMED continues to evolve as the backbone of EU medical device regulation. With new modules like Market Surveillance and enhanced certificate management, stakeholders gain better tools to ensure patient safety and regulatory compliance.
For guidance visit:https://lnkd.in/ghhvbEec
MDCG
Understanding IVDR Classification: A Practical Guide to MDCG 2020-16
Published: March 2025
The European Union’s In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 has significantly reshaped how diagnostic devices are classified and regulated. At the centre of this transformation lies MDCG 2020-16 rev.4, a guidance document that clarifies how in vitro diagnostic (IVD) devices are classified under Annex VIII of the IVDR. For manufacturers, regulatory professionals, and quality experts, this guidance is essential to navigating compliance and ensuring patient safety.
Importance
Classification determines the conformity assessment route, the level of notified body involvement, and the evidence required to demonstrate safety and performance. Misclassification can lead to costly delays, compliance risks, and even market withdrawal.
Classification
IVDR devices are classified into four risk-based categories:
Intended Purpose Drives Classification
Classification depends primarily on the intended purpose defined by the manufacturer
This includes :
Even subtle wording differences can change classification.
For example:
Overview of IVDR Classification Rules
The IVDR classification framework includes 7 core rules, each addressing different types of IVDs.
Rule 1: High-Risk Infectious Disease Testing (Class D)
Covers devices detecting:
Rule 2: Blood Grouping and Compatibility (Class C/D)
These tests directly impact transfusion safety, making accuracy essential.
Rule 3: Broad Category of High-Impact Clinical Tests (Class C)
Rule 3 includes:
Rule 4: Self-Testing and Near-Patient Testing
Rule 5: Low-Risk Laboratory Products (Class A)
Includes:
Rule 6: Default Rule (Class B)
Devices not covered by other rules fall into Class B.
Rule 7: Controls (Class B)
Unassigned controls (no fixed value) are classified as Class B, unless linked to higher-class devices.
Final Thoughts
MDCG 2020-16 is a roadmap for risk-based thinking in diagnostics. Understanding classification is essential not only for compliance but also for building trust in diagnostic technologies. For guidance read more
USA Updates
FDA : Guidance on Human Factors in Medical Device Submissions
Date: May 29, 2026
The U.S. Food and Drug Administration (FDA) released latest guidance on the Content of Human Factors Information in Medical Device Marketing Submissions. This document provides a risk-based framework for determining what human factors engineering (HFE) and usability engineering (UE) related information required for 510(k)s, PMAs, De Novo requests, and Humanitarian Device Exemptions (HDEs).
Importance
The goal of the human factors assessment is to ensure that the device user interface has been designed such that use errors are either eliminated or reduced to the extent possible.
The Risk Based Approach
The FDA uses a structured decision process to place submissions into three Human Factors Submission Categories:
Changes that do not affect human factors only require a conclusion and a complete summary of prior human factors evaluations.
Changes to a device that do not create new or affect existing critical tasks requires a rationale supported by risk analysis and evidence that currently controls remain effective.
New devices or modifications that affect critical tasks requires a complete HFE/UE report, including human factors validation testing.
Implications for Industry
Tasks for Manufacturers
Conclusion
The FDA’s May 2026 guidance emphasizes human factors as a core element of medical device regulation. Adopting this risk based, structured approach helps manufacturers streamline submissions while supporting device safety, effectiveness, and usability.
Reference
Content of Human Factors Information in Medical Device Marketing Submissions
Australia Updates
Australia’s Updated Implementation of Unique Device Identification (UDI)
The Therapeutic Goods Administration (TGA) has released updated guidance (Version 2.0, May 2026) on complying with Unique Device Identification (UDI) timeframes for medical devices and IVDs in Australia.
Importance
The UDI system was introduced to address challenges in tracking and tracing medical devices. In the past there have been safety issues involving hip implants, urogynaecological mesh and breast implants which forced the need for faster, more reliable identification of devices supplied or implanted in patients.
Timeline
Milestones
Each device class has two compliance milestones:
Transitional Arrangements
Task for Manufacturer
Manufacturers and sponsors should:
For guidance visit: https://lnkd.in/ghhvbEec
Malaysia Updates
Malaysia’s Updated Medical Device Labelling Requirements Guidance
In May 2026, the Medical Device Authority (MDA), Ministry of Health Malaysia, released the 7th Edition of the Guidance Document on Labelling Requirements for Medical Devices (MDA/GD/0026).
Key Updates
Conclusion
Malaysia’s 7th Edition Labelling Guidance represents a significant step toward global harmonisation while addressing local needs. By strengthening requirements for clarity, accessibility, and risk management, the MDA is ensuring that medical devices in Malaysia are safer, more transparent, and easier to use.
For manufacturers it is time to review labelling practices, integrate e labelling and ensure compliance with mandatory contact and language requirements.
For guidance read more
Team NB Updates
Team – NB Expert Opinion on Proposed Article 50 MDR
On 11 May 2026, Prof. Dr. Ulrich Haltern (LMU Munich) published an expert opinion on the European Commission’s proposal to amend the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The Proposed Article 50, which introduces mandatory fee reductions, payment deferrals, and compelled acceptance of conformity assessment requests for notified bodies.
Although the objectives supporting SMEs, orphan-device manufacturers and ensuring access to conformity assessment the opinion raises serious concerns about compatibility with Union law.
The Article 50 Proposes
The Commission’s draft would require notified bodies to:
Fundamental Rights Concerns
The opinion concludes that these measures interfere with the freedom to conduct a business under Article 16 of the Charter of Fundamental Rights of the EU (CFREU).
Proportionality and Alternatives
The opinion acknowledges the Commission’s goals reducing burdens on SMEs, fostering innovation, and safeguarding public health but argues that the chosen means are disproportionate.
Article 50(3) and Implementing Powers
A further issue arises under Article 291 TFEU, which limits the Commission’s use of implementing acts. Article 50(3) would empower the Commission to determine fee structures and levels without cost-based safeguards or recovery mechanisms.
Conclusion
The expert opinion concludes that Proposed Article 50 is invalid and unenforceable. It disproportionately interferes with notified bodies’ rights under Article 16 CFREU and exceeds the permissible scope of implementing powers under Article 291 TFEU. While the Union legislature enjoys wide discretion in regulating medical devices, it cannot reallocate public-interest burdens private undertakings without compensation or safeguards.
ISO Updates
ISO Medical Device Standards Update : 1 April — 1 May 2026
The May 2026 ISO Update presents several committee drafts (CDs), draft international standards (DIS), and final drafts (FDIS) relevant to medical technology. These updates directly impact manufacturers and healthcare providers for safety, performance, and compliance.
Biological and Clinical Evaluation of Medical Devices (TC 194)
Sterilization of Healthcare Products (TC 198)
Impact: Strengthens validation requirements for endoscope reprocessing, addressing infection control risks in hospitals.
Anaesthetic and Respiratory Equipment (TC 121)
Impact: It provides harmonized criteria for defining performance specifications in IVD testing, improving comparability and reliability of diagnostic results.
In Vitro Diagnostic Medical Devices (TC 212)
Impact: Provides harmonized criteria for defining analytical performance in IVD testing, improving comparability and reliability of diagnostic results.
Implants for Surgery (TC 150)
Impact: Updates dimensional and test requirements for connectors to improve reliability and patient safety in cardiac implants.
Conclusion
The May 2026 ISO Update reflects the continuous evolution of medical device standards. Stakeholders across manufacturing, laboratory, and clinical settings should review these documents and update procedures as needed to maintain compliance, ensure patient safety, and preserve market access.
To read more visit: https://www.iso.org/iso-update.html
Sushvin Provides UK Responsible Person (UK RP) Services
Are you a legal medical device/IVD manufacturer located outside the UK and would like to market your product in the UK, then you will require a UK responsible person who will act on behalf of the manufacturer to ensure all the responsibilities detailed within the updated UK MDR 2002 regulations are met.
As a legal manufacturer, organisations will have to register their devices prior to be placed on the UK market.
If you need UK Responsible Person (UK RP) services, please contact SUSHVIN for more information.
If you are planning to market your product in the EU and if you require PRRC (Person Responsible for Regulatory Compliance), we have a team of experienced regulatory professionals who can help you assist with PRRC services and get you regulatory compliant as per MDR 2017/745 and IVDR 2017/746
If you need PRRC Services, please contact SUSHVIN for more information.
