Medical Device Testing Checklist for UK Manufacturers (2026)

Introduction

With the onset of 2026, UK manufacturers face the first full planning cycle following two pivotal changes in Great Britain: 

• CE marking acceptance ended on 30 June 2025 
• UKCA marking has been required since 1 July 2025 under MHRA guidance 

In parallel, changes to post-market surveillance (PMS) for UK devices took effect in mid-2025, tightening expectations around data collection, vigilance, and proactive risk control. 

If you also sell into the EU, the Medical Device Regulation (EU) 2017/745 (MDR) continues to reshape evidence and testing expectations across the lifecycle, with transitional provisions updated by Regulation (EU) 2023/607. 

This post outlines what a 2026-ready testing plan should look like for UK manufacturers. It presents a practical checklist that can be adopted immediately. 

The focus remains evidence-led and standards-based, aligned with how regulators assess submissions and surveillance: 

• Is the risk understood? 
• Are risk controls appropriate and verified? 
• Is the information for safe use validated? 

This checklist is not exhaustive, and the order does not necessarily reflect how topics should be approached. However, it should provide a useful starting point to evaluate your testing regime and allocate an accurate budget to support a smoother certification process.

Overview of the 2026 Regulatory Landscape 

Before reviewing the checklist, it is helpful to step back and consider the broader regulatory context. 

Great Britain Market Access 

UKCA marking is required for devices placed on the GB market. CE marking recognition ended on 30 June 2025 under MHRA guidance. 

Northern Ireland remains under EU rules (CE or CE+UKNI where applicable). 

2026 is the first year where fallback reliance on CE marking is no longer an option for GB. 

UK MDR and PMS

The UK Medical Devices Regulations 2002 (as amended) remain the legal basis for GB devices. 

PMS updates effective 16 June 2025 (Statutory Instrument 2024 No. 1368) increase emphasis on: 

• Proactive surveillance 
• Trend reporting 
• Timely field safety corrective action 

PMS findings will increasingly be assessed against what you validated at launch. 

EU Context for Dual-Market Strategies

MDR clinical evidence, risk management, and post-market requirements continue to apply, with transitional timelines adjusted by Regulation (EU) 2023/607. 

If you intend to retain CE marking for the EU (and Northern Ireland), testing strategies should be designed to satisfy both MDR and UKCA without duplication, using harmonised or designated standards where feasible. 

Misaligned test plans can create unnecessary cost and rework. 

Biocompatibility and Material Compatibility

(ISO 10993 series) 

Start with a Biological Evaluation Plan (BEP) in accordance with ISO 10993-1. This should be grounded in: 

• Clinical use 
• Contact type and duration 
• Existing material and process knowledge 

Chemical characterisation (ISO 10993-18) and toxicological risk assessment (ISO 10993-17) are central to modern programmes, particularly for polymeric systems, coatings, and devices exposed to reprocessing agents. 

Consider potential residues from cleaning procedures and repeated exposure to reprocessing cycles that may affect long-term biocompatibility. 

Regulators will expect clear justification if tests are omitted. Risk-based reasoning tied to materials, processing, extractables/leachables, and clinical context is essential. 

Sterilisation Validation

Moist heat: 

• ISO 17665 for validation and routine control 

Ethylene oxide: 

• ISO 11135 for process qualification 
• Demonstrate residual compliance via ISO 10993-7 

Radiation: 

• ISO 11137 for dose establishment and routine control 

For reusable devices, ensure reprocessing instructions are technically validated (see usability section below). 

Sterility assurance level (typically 10⁻⁶) and residual compliance remain routine areas of regulatory scrutiny. 

Packaging Validation and Shelf Life

(ISO 11607 and supporting ASTM methods) 

Design and validate sterile barrier systems and packaging processes per: 

• ISO 11607-1 
• ISO 11607-2 

Use appropriate ASTM methods to generate robust data, including: 

• ASTM F1980 – accelerated ageing 
• ASTM F88 – seal strength 
• ASTM D4169 – distribution simulation 

Shelf-life claims must be supported by: 

• Stability data 
• Packaging integrity 
• Functional performance over time 

Label claims (for example, five-year shelf life) should be clearly justified. 

Electrical Safety and EMC

(IEC 60601 series) 

For active devices: 

• IEC 60601-1 – basic safety and essential performance 
• IEC 60601-1-2 – EMC 

Identify relevant collateral or particular standards (for example, IEC 60601-1-8 for alarms or applicable device-specific parts). 

Risk analysis should capture essential performance degradation under EMC disturbance and environmental stress. 

EMC failures often surface late in development and can delay certification. 

Software Lifecycle and Cybersecurity

(IEC 62304 and related standards) 

Classify software safety class and implement a documented lifecycle process covering: 

• Development planning 
• Risk management 
• Verification and validation 
• Maintenance 

Link IEC 62304 activities to: 

• Hazard analysis under ISO 14971 
• User interface risks under IEC 62366-1 

Cybersecurity should be addressed as part of risk control and verification, including: 

• Threat modelling 
• Secure development 
• Update and patch strategy 
• Field monitoring 

Usability Engineering and IFU Validation

(IEC 62366-1; reprocessing validation) 

Conduct formative studies to refine design and labelling. 

Execute summative (validation) studies with representative users, environments, and critical tasks to demonstrate that residual use-related risk is acceptable. 

For reusable devices: 

• Validate cleaning and disinfection steps described in the IFU 
• Consider ISO 17664 and applicable washer-disinfector standards where relevant 

Poorly validated instructions frequently generate post-market issues. 

Risk Management and QMS Expectations

(ISO 14971 and ISO 13485) 

Maintain a living risk management file per ISO 14971, with explicit traceability from: 

• Hazards 
• To risk controls 
• To verification and validation evidence 

Your testing strategy should clearly verify the effectiveness of each control (e.g., insulation distances under IEC 60601-1, labelling mitigations through usability validation, biocompatibility via ISO 10993 testing). 

Integrate post-market data (complaints, vigilance, adverse trend analysis) into risk review and CAPA. 

Under updated UK PMS expectations, proactive surveillance and timely communication to the MHRA are critical. 

ISO 13485 remains the backbone of your QMS. Ensure design controls, purchasing controls, production validation, and data integrity practices support credible and reproducible test results. 

Final Perspective for 2026

The emphasis should always be on actionable evidence: 

• Tests designed to answer the right regulatory questions the first time. 
• Evidence that builds a defensible technical file. 
• Validation that stands up to MHRA and EU scrutiny. 

In practical terms, a strong plan does three things well: 

It is risk-anchored.
Every test maps to a specific hazard or performance claim, and evidence is easy to locate in the technical file. 

It is standards-driven.
The right standards are selected once and leveraged across markets to reduce duplication. 

It anticipates PMS.
Validation reflects real-world use – user variability, environment, reprocessing, packaging stress, and cybersecurity exposure – so post-market signals are more manageable. 

If you would like to review your current testing strategy or align UKCA and MDR requirements without duplication, talk to an expert to assess your 2026 readiness.