A number of newly issued or updated standards reflect an important shift in the medical device and healthcare sector towards stronger risk management, digitalisation, software governance, patient safety and regulatory transparency.
BS EN IEC 61326-1:2021+A11:2026 reinforces Electromagnetic Compatibility (EMC) requirements for laboratory, measurement and control equipment. While not a fundamental rewrite of the existing standard, the A11 amendment aligns European requirements with evolving regulatory expectations, helping ensure equipment performs reliably in increasingly complex electronic environments.
BS EN ISO 22367:2026 represents a significant advancement in laboratory quality management by strengthening the application of risk management across the entire testing pathway. The revised edition places greater emphasis on proactive risk identification, patient safety, electronic data transfer and integration with ISO 15189 laboratory requirements.
BS ISO/IEC/IEEE 12207:2026 modernises software life cycle management. The updated framework accommodates agile, iterative and hybrid development approaches while maintaining end-to-end control of software acquisition, development, operation, maintenance and retirement. For medical device software and Software as a Medical Device (SaMD), this reflects the industry's move towards continuous development and lifecycle assurance.
BS EN ISO 20417:2026 updates requirements for information supplied by medical device manufacturers. The revision strengthens expectations surrounding labelling, instructions for use, Unique Device Identification (UDI), digital information, supply-chain responsibilities and global regulatory consistency. The change supports increasing regulatory scrutiny under frameworks such as EU MDR and related international regulations.
BS EN 18167:2026 focuses on quality throughout the radiology patient pathway, shifting attention from individual imaging procedures to the entire patient journey. The standard promotes integrated quality systems, consistency of care and optimisation of patient outcomes across diagnostic imaging services.
CLSI PRE04:2023 reflects growing recognition that pre-analytical variables significantly influence laboratory results. By standardising blood specimen handling, transport, processing, and storage, the guideline seeks to reduce variability and improve diagnostic reliability.
ANSI/AAMI EQ56:2024 modernises healthcare technology management by encouraging a risk-based, lifecycle approach to medical equipment oversight. The guidance moves organisations beyond simple maintenance schedules towards comprehensive governance covering acquisition, utilisation, cybersecurity, performance monitoring and retirement.
Collectively, these standards demonstrate a broader industry transition from compliance-focused management to a more holistic, risk-based approach centred on patient safety, data integrity, digital technologies and lifecycle control.
RSSL provides microbiological analysis, medical device testing and physical and structural characterisation services to support manufacturers meeting updated standards. We also deliver GMP, risk management and auditing training to help organisations embed proactive, lifecycle-based quality systems.
A European Standard has been issued for healthcare. This is CSN EN ISO 15883-6, titled ‘Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-critical medical devices and health care equipment’.
This standard specifies requirements for Washer-Disinfectors (WD) intended for use when the level of assurance of disinfection that is necessary can be achieved by cleaning and thermal disinfection (A0 not less than 60) and does not require an independent automated record of critical processes to be kept. It is intended to be used in conjunction with ISO 15883-1, which specifies general requirements for WD.
As mentioned in the previous Regulatory Roundup, the International Organization for Standardization (ISO) has updated ISO 9001:2026, Quality Management Systems - Requirements.
The new edition introduces targeted updates to improve clarity, usability and relevance while building on the familiar framework organisations already use. It places greater emphasis on leadership, and a culture of quality and ethical behaviour, while providing greater clarity on the consideration of risks and opportunities to support better strategic decision-making. A new section also helps users better understand the intent of the requirements and apply them consistently.
The document is available from ISO or from national standards bodies (such as BSI in the UK).
ISO are developing two standards which will impact on analytical laboratories:
ISO are updating one of the cleanroom related standards, relating to separative devices (which includes pharmaceutical isolators):
RSSL delivers GMP training, IRCA-accredited auditing courses and quality systems consultancy to support organisations through the transition.
The U.S. ASTM (formerly the American Society for Testing and Materials) has introduced an updated standard - E3543-26: ‘Standard Practice for Evaluating Bactericidal Activity of Nonporous, Semi-porous, and Hydrophobic Antimicrobial Surface Products Used Indoors’.
This standard covers bactericidal claims for non-food-contact antimicrobial surfaces, including nonporous, semi-porous and hydrophobic surfaces. The standard is also applicable for determining the efficacy of additives containing active ingredients that are incorporated into otherwise non-antimicrobial surface materials, such as paints and coatings, by comparing a surface containing the antimicrobial agent with a surface lacking the antimicrobial additive.
1. Antimicrobial claims must be supported by robust, realistic efficacy testing
Antimicrobial surfaces must demonstrate performance under conditions that mimic real-world contamination, using wet microbial droplets deposited onto dry surfaces
The method is designed to generate meaningful performance data, including demonstration of at least a 3-log reduction in bacteria within a 2-hour contact period
Manufacturers should ensure testing protocols and claims are supported by scientifically robust and reproducible evidence
2. Risk-based validation should focus on clinically relevant microorganisms
3. Compliance extends beyond the test method itself
RSSL offers microbiological analysis and method development to support manufacturers generating bactericidal efficacy data.
During August 2026, ISO issued ISO 13647:2026 ‘Water quality - Enumeration of culturable microorganisms - Colony count by spread plate inoculation on R2A medium’. The document specifies a method for the enumeration of culturable microorganisms in water by counting colonies on a low-nutrient agar culture medium by spread plate inoculation after incubation at 22 °C for 7 days.
The standard is applicable to both chlorinated and non-chlorinated water in distribution systems and containers, as well as aiding pharmaceutical laboratories subculturing from tests conducted on bulk water systems.
RSSL provides pharmaceutical water bioburden monitoring and can support the validation of R2A-based enumeration methods.
The new ICH document - M13B - is a guideline intended to provide recommendations on obtaining waivers of Bioequivalence (BE) studies for one or more additional strengths of a drug product in an application where in vivo BE has been demonstrated for at least one of the strengths. The guideline is applicable during both development and post-approval phases of orally administered Immediate Release (IR) solid dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules and granules/powders for oral suspension.
The ICH M13B guideline is the second guideline in the ICH series describing the scientific and technical aspects of study design and data analysis to support BE assessment for orally administered IR solid oral dosage forms.
The document comes into effect on 17 March 2027, superseding applicable parts of the EMA guideline related to additional strength biowaivers.
The document can be accessed here: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-m13b-guideline-bioequivalence-immediate-release-solid-oral-dosage-forms-additional-strengths-biowaiver-step-5_en.pdf
There is also a supporting Question and Answer document: ICH M13B Q&A_ Guideline on bioequivalence for immediate-release solid oral dosage forms - Questions & Answers_Step 5
Fewer bioequivalence studies may be needed for additional strengths: If bioequivalence has already been demonstrated for one strength, manufacturers may be able to obtain regulatory approval for additional strengths without conducting further in vivo studies, provided formulation, manufacturing process and dissolution performance meet defined criteria. This can reduce development time, costs and unnecessary human exposure in clinical studies
RSSL supports biowaiver applications with ICH-compliant stability studies, method development and GMP release testing.
The European Medicines Agency (EMA) has produced a draft scientific guideline relating to topical medicines. The guideline, which was developed to encourage optimal use and to minimise selection of Antimicrobial Resistance (AMR), was revised in order to improve consistency of the Summary of Product Characteristics (SPCs) for antimicrobial products in the EU Member States.
The draft is an update of the 2018 edition and it is currently open for comments. The document can be accessed here: https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-user-safety-topically-administered-veterinary-medicinal-products-revision-1_en.pdf
User safety assessments for topical veterinary products will become more rigorous and data-driven: The draft guideline strengthens expectations around assessing human exposure to veterinary medicines applied to animals, including accidental contact, transfer from treated animals, dermal absorption, ingestion and eye exposure. Companies will need more robust evidence to demonstrate that risks to pet owners, veterinary staff and household members have been adequately evaluated
RSSL provides physical and structural characterisation and extractables and leachables testing to support formulation and exposure data requirements.
The EMA has reached the final stage with the document ‘Guideline on good pharmacovigilance practices Module III - Pharmacovigilance inspections (Rev 2)’.
The module contains guidance on the planning, conduct, reporting and follow-up of pharmacovigilance inspections in the EU and outlines the role of the different parties involved. General guidance is provided under III.B., while III.C. covers the overall operation of pharmacovigilance inspections in the EU.
The document can be accessed here: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-iii-pharmacovigilance-inspections-rev-2_en.pdf
Be inspection-ready at all times, not just before an audit: The revised guidance reinforces a risk-based pharmacovigilance inspection model, including routine, for-cause, announced, unannounced and remote inspections. Marketing authorisation holders must be able to demonstrate that their pharmacovigilance systems, personnel, procedures and documentation are continuously maintained and inspection-ready
RSSL delivers IRCA-accredited auditing training and inspection readiness consultancy to support pharmacovigilance compliance.
The EMA has updated the risk assessment template for pharmaceutical companies undertaking medicinal supply shortages or disruptions (as per the requirement in EU GMP Chapter 1).
This can be found here: https://www.ema.europa.eu/en/documents/template-form/shortage-prevention-plans-spp-template_en.pdf
A new £20m programme to create four new Centres of Excellence for Regulatory Science and Innovation (CERSIs), with each funded for up to five years, is set to strengthen the UK’s capability and agility in regulatory science and help ensure regulation keeps pace with rapid advances in healthcare and life sciences.
Developed through a partnership between the Medicines and Healthcare products Regulatory Agency (MHRA), the Medical Research Council (MRC) and the Office for Life Sciences (OLS), the funding opportunity, launched on 22 September 2026, is inviting applications to establish the four centres.
The CERSIs will bring together world-leading expertise from across academia, industry, healthcare and regulation to develop practical solutions to emerging regulatory challenges and help ensure new innovations can be safely adopted in practice.
Further details can be found here: https://www.ukri.org/opportunity/centres-of-excellence-for-regulatory-science-and-innovation/
The UK government has proposed a Health Bill aimed at modernising the legislative framework for the regulation of medicines and medical devices in the UK. The bill includes measures on:
According to the UK Government: ‘These reforms will make it easier to keep medicines and medical devices regulation up to date. They will support faster responses to scientific developments, technological innovation and changes in clinical practice, while maintaining appropriate consultation and parliamentary oversight.’
Details can be found here: https://www.gov.uk/government/publications/health-bill-medicines-and-medical-devices-regulatory-reforms-fact-sheet/health-bill-medicines-and-medical-devices-regulatory-reforms-fact-sheet
The UK government has issued a document that outlines the scientific requirements for evaluating the identity, production processes and microbiological hazards of Cell Cultivated Products (CCPs) when seeking market authorisation as novel foods in Great Britain. This functions as supplemental guidance to the 2016 European Food Safety Authority (EFSA) technical guidance which supports applicants through assimilated regulation (EU) 2017/2469 and details administrative and scientific requirements for novel food applications under Article 10 of assimilated regulation (EU) 2015/2283 for novel foods.
The supplemental guidance aims to help applicants understand the safety assessments required relating to identity, production and microbiological hazards of CCP production. It should be read in conjunction with Article 10 of assimilated regulation (EU) 2015/2283 and the 2016 EFSA technical guidance, which continue to apply to CCP safety assessments.
Further details are available here: https://www.gov.uk/government/publications/cell-cultivated-products-identity-production-and-microbiology/supplementary-guidance-to-applicants-for-the-assessment-of-cell-cultivated-products-in-food-identity-production-and-microbiology
In related news, BioPhorum has issued guidance on cell culture media. Chemically defined media plays a critical role in biopharmaceutical manufacturing, but variability in individual media components can have significant consequences for cell culture performance, product quality and process consistency. Understanding which material attributes matter most - and how best to control them - is therefore essential.
The guide provides a structured, Quality by Design (QbD)-based approach to identifying and managing critical material attributes in cell culture media. It introduces a target material profile methodology and a practical QbD matrix that helps users assess individual media components according to their potential impact, variability and detectability.
For details, see: https://www.biophorum.com/download/identifying-critical-material-attributes-in-cell-culture-media-a-practical-industry-guide/
RSSL provides biosafety testing, microbiological analysis and contamination identification to support cell-cultivated product safety dossiers.
Oligonucleotides and peptides occupy a unique position at the intersection of traditional small molecule and biologic manufacturing. While both rely on synthetic chemical processes and solvent-based operations, they also present distinct challenges related to contamination control, purification technologies, process scale-up, facility classification and environmental management. These characteristics often result in varied interpretations of facility requirements and create a need for modality-specific guidance.
The International Society for Pharmaceutical Engineering (ISPE) has issued a guide for GMP facility design, process integration, contamination control, risk management, scale-up, sustainability and regulatory compliance. It is an essential reference for organisations supporting the next generation of therapeutic manufacturing.
For further details, see ISPE: https://ispe.org/publications/guidance-documents/guide-oligonucleotide-and-peptide-manufacturing-facilities
RSSL provides peptide characterisation, purity assessment and ICH stability studies to support GMP-compliant manufacturing.
The U.S. Food and Drug Administration (FDA) has issued a direct final rule that updates its regulations to clarify that non-animal methods can be used where appropriate for testing the safety of drugs and biological products intended for human use. The update reflects advances in science and technology that have expanded the range of testing options available in human drug development, including methods using human cells, organs-on-chips, computer models and other advanced technologies.
The rule replaces terms like ‘animal tests’ and ‘animal studies’ with the terms ‘nonclinical tests’ and ‘nonclinical studies’. Related terms, including ‘preclinical’ and ‘in vitro’, are also replaced. The rule defines ‘nonclinical test’ and ‘nonclinical study’ in line with the Food and Drug Omnibus Reform Act (FDORA) of 2022. The law recognises newer methods that do not use animals and traditional animal studies as possible ways to provide the evidence needed to begin studies in people.
The rule also removes language that could suggest that animal testing is the only acceptable way to generate safety information for regulatory decisions in products intended for human use. It does not eliminate or prohibit animal studies, change evidentiary standards or impose new costs or requirements on drug developers.
Further details can be found here: https://www.fda.gov/news-events/press-announcements/fda-updates-regulations-advance-innovative-alternatives-animal-testing
RSSL offers biosafety testing and biologics analytical services, including in vitro and cell-based approaches for nonclinical evaluation.
While this Regulatory Round-up gives you a broad snapshot of changes across the pharmaceutical landscape, our quarterly Key GMP Regulatory Updates webinar offers the chance to go deeper on what matters most for your quality systems.
