EU MDR

Definition

EU MDR — Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, the European Union's Medical Devices Regulation. It establishes the main framework for placing medical devices on the EU market and regulating them, covering classification, conformity assessment, technical documentation, clinical evaluation, post-market surveillance, UDI, economic operator responsibilities and CE marking.^[1]

MDR applies to devices within its scope and replaces Council Directives 90/385/EEC and 93/42/EEC. Its core aim is to keep the EU medical-device market functioning while ensuring a high level of protection for patients' and users' health and safety.^[1]

For wet wipe products, whether MDR applies depends on intended purpose, mode of action and claims, rather than product form alone. Some wipes, dry wipes, care products or device accessories used for medical purposes, such as disinfecting medical devices, may enter an MDR pathway.

References

[1]European Parliament and Council of the European Union. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.

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12 terms

Basis Weight, GSM

Grammage, commonly expressed as GSM (grams per square metre), is the mass of a material per unit area.

Wet Wipes Fundamentals
CLP Regulation

CLP Regulation — Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures, the EU Classification, Labelling and Packaging Regulation. CLP is based on the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS).[1][2]

Laws & Regulations
Cosmetic Product Safety Report (CPSR)

A Cosmetic Product Safety Report (CPSR) is the product safety assessment document required under Regulation (EC) No 1223/2009 on cosmetic products; its content and structure are specified in Article 10 and Annex I.[1]

Testing Standards
Cosmetic Products Notification Portal (CPNP)

The Cosmetic Products Notification Portal (CPNP) is a free online cosmetic product notification system established by the European Commission.[1][2]

Laws & Regulations
Embossing

Embossing is the mechanical process of forming raised and recessed patterns on film, nonwoven or another sheet. It can change surface texture, appearance, touch, friction and the contact structure used during cleaning.

Wet Wipes Fundamentals
EN (European Norm)

EN standards are European standards developed through transparent, consensus-based processes by recognized European standardization organizations. They provide a common framework for evaluating antimicrobial efficacy and other performance claims.

Testing Standards
EN 13624

EN 13624 is a Phase 2 Step 1 quantitative suspension test for evaluating fungicidal or yeasticidal activity of chemical disinfectants and antiseptics in the medical area. It specifies minimum requirements and test organisms for the relevant claims.

Testing Standards
EN 13727

EN 13727 is a Phase 2 Step 1 quantitative suspension test for evaluating bactericidal activity of chemical disinfectants and antiseptics in the medical area under specified organisms, interference conditions, concentration, temperature and contact time.

Testing Standards
EN 14348

EN 14348 is a Phase 2 Step 1 quantitative suspension test for evaluating mycobactericidal and, where applicable, tuberculocidal activity of chemical disinfectants in the medical area, including instrument disinfectants.

Testing Standards
EN 14476

EN 14476 is a Phase 2 Step 1 quantitative suspension test for evaluating virucidal activity in the medical area. It evaluates reductions in viral infectivity under specified virus, interference, concentration, temperature and contact-time conditions.

Testing Standards
EN 14885

EN 14885 is the framework standard for European efficacy testing of chemical disinfectants and antiseptics. It connects product claims with the specific EN test methods that should be used, including Phase 2 Step 1 suspension tests and Phase 2 Step 2 practical-use tests.

Testing Standards
EN 1500

EN 1500 is a Phase 2 Step 2 practical-use standard for evaluating the efficacy of hygienic handrub products on human hands. It compares the product with a reference procedure to assess reduction of transient microbial flora.

Testing Standards
EN 16615

EN 16615 is a Phase 2 Step 2 practical-use test for evaluating bactericidal, yeasticidal, fungicidal, tuberculocidal and mycobactericidal activity on non-porous surfaces using wipes or mops with mechanical action. Its four-field method assesses both microbial reduction and prevention of transfer to adjacent areas.

Testing Standards
EN 17126

EN 17126 is a Phase 2 Step 1 quantitative suspension test for evaluating sporicidal activity of chemical disinfectants in the medical area under specified spores, interference conditions, concentration, temperature and contact time.

Testing Standards
EN 17846

EN 17846 is a Phase 2 Step 2 four-field test for evaluating sporicidal activity against Clostridioides difficile on non-porous surfaces with mechanical action using wipes. It is relevant to practical surface disinfection, including pre-impregnated ready-to-use disinfectant wipes.

Testing Standards
EPA

EPA — the United States Environmental Protection Agency — is the U.S. federal agency responsible for protecting human health and the environment. Its responsibilities include administering and enforcing multiple federal laws related to environmental and public-health protection.[1]

Laws & Regulations
EU BPR

EU BPR — Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products, the EU Biocidal Products Regulation.[1]

Laws & Regulations
EU Cosmetics Regulation

EU Cosmetics Regulation — Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. It establishes the common rules for placing cosmetics on the EU market, supporting the functioning of the internal market and a high level of protection for human health.[1]

Laws & Regulations
EU MDR

EU MDR — Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, the European Union's Medical Devices Regulation. It establishes the main framework for placing medical devices on the EU market and regulating them, covering classification, conformity assessment, technical documentation, clinical evaluation, post-market surveillance, UDI, economic operator responsibilities and CE marking.[1]

Laws & Regulations
FD&C Act

FD&C Act — the Federal Food, Drug, and Cosmetic Act — is one of the foundational U.S. federal laws used by the FDA to regulate foods, drugs, medical devices and cosmetics. Its current statutory provisions are primarily codified in Title 21, Chapter 9 of the United States Code.[1]

Laws & Regulations
FIFRA

FIFRA — the Federal Insecticide, Fungicide, and Rodenticide Act — is a core U.S. federal law regulating the production, registration, distribution, sale and use of pesticides. FIFRA gives the U.S. Environmental Protection Agency (EPA) legal authority over pesticide products.[1]

Laws & Regulations
Flip-top Lid / Flip-top Closure

A flip-top lid is a rigid or semi-rigid hinged closure fitted over the dispensing opening of a wet wipe pack. It supports resealing, stable dispensing and moisture protection, and may be combined with an internal resealable label.

Wet Wipes Fundamentals
FSC Chain of Custody Certification

FSC Chain of Custody (CoC) certification verifies that forest-based materials meeting FSC requirements are appropriately identified and tracked through the supply chain, from sourcing to processing, manufacturing and distribution.

Factory Qualifications
GB (Chinese National Standard)

GB is one of the designations in China’s national standards system. GB identifies mandatory national standards, GB/T identifies recommended standards, and GB/Z identifies national standardization guidance documents.

Testing Standards
Global Security Verification (GSV)

Global Security Verification (GSV) is a global supply chain security verification program developed by Intertek. It helps importers and suppliers identify and reduce security risks in cross-border freight transportation and global supply chains.

Factory Qualifications
Good Manufacturing Practice (GMP)

Good Manufacturing Practice (GMP) is a set of principles and management systems designed to ensure that products are consistently manufactured and controlled to quality standards appropriate to their intended use. WHO regards GMP as an important part of quality assurance. Its core purpose is to systematically manage personnel, premises, materials, production processes, quality control and documentation to reduce manufacturing risks that cannot be fully eliminated through final product testing alone.

Factory Qualifications
ISO 13485

ISO 13485 is an international quality management system standard specifically developed for the medical device industry. It specifies requirements for a quality management system that enables organizations to consistently meet customer requirements and applicable medical device regulatory requirements.

Factory Qualifications
ISO 14001

ISO 14001 is an internationally recognized environmental management system (EMS) standard. It provides a framework for establishing, implementing and continually improving an environmental management system, enabling organizations to systematically manage their environmental impacts, applicable regulatory obligations and environmental objectives.

Factory Qualifications
ISO 22716

ISO 22716 is international GMP guidance developed for the cosmetics industry. Its official scope covers the production, control, storage and shipment of cosmetic products.

Factory Qualifications
ISO 45001

ISO 45001 is an international standard for occupational health and safety (OH&S) management systems. It specifies management system requirements for managing occupational health and safety risks and improving OH&S performance.

Factory Qualifications
ISO 9001

ISO 9001 — Quality management systems — Requirements is an internationally used quality management system (QMS) standard. It specifies requirements for establishing, implementing, maintaining and continually improving a quality management system to help organizations consistently meet customer requirements and improve quality management performance.

Factory Qualifications
Lotion Loading / Liquid Loading / Wetting Ratio

Lotion loading expresses the amount of liquid carried by a wet wipe substrate, commonly as grams of liquid per gram of dry substrate. The appropriate loading depends on fiber, structure, basis weight, absorbency, liquid release and the intended use.

Wet Wipes Fundamentals
MoCRA

MoCRA — the Modernization of Cosmetics Regulation Act of 2022 — is a major expansion of the U.S. FDA's cosmetics authority and the most significant change to U.S. cosmetics oversight since the FD&C Act was enacted in 1938.[1]

Laws & Regulations
Nonwoven Fabric / Nonwoven

Nonwoven fabric is a sheet material made mainly from fibers that gain structural integrity through physical and/or chemical processes rather than weaving or knitting. Fiber, process, basis weight and surface structure all affect softness, strength, absorbency and lint control.

Wet Wipes Fundamentals
PPWR

PPWR — Regulation (EU) 2025/40 of the European Parliament and of the Council of 19 December 2024 on packaging and packaging waste, the EU Packaging and Packaging Waste Regulation.[1]

Laws & Regulations
REACH

REACH — Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals. The name REACH comes from Registration, Evaluation, Authorisation and Restriction of Chemicals.[1]

Laws & Regulations
Resealable Label

A resealable label is a peel-and-reseal closure covering the dispensing opening of a flexible wet wipe pack. It provides access, reseals the opening after use, limits moisture loss and reduces the chance of outside contamination.

Wet Wipes Fundamentals
Rollstock Flexible Packaging

Rollstock flexible packaging uses a roll of flexible film that is unwound, formed, sealed and cut on an automatic packaging line to make wet wipe packs. The package must provide liquid and water-vapor barriers and a seal compatible with the formulation.

Wet Wipes Fundamentals
SDS / MSDS

SDS — Safety Data Sheet — is a standardized document used to communicate chemical hazards, safe use, storage, emergency response and protective measures. MSDS — Material Safety Data Sheet — is the historical name; as GHS systems and national regulations have become more aligned, SDS is the current standard term. OSHA's HazCom 2012 also changed the name from “Material Safety Data Sheet” to “Safety Data Sheet”.[1]

Laws & Regulations
SMETA 4-Pillar Audit

SMETA is an on-site social audit methodology developed by Sedex. It uses a standardized approach to assess working conditions and responsible business practices at supply chain workplaces.

Factory Qualifications
Spunlace Nonwoven / Hydroentangled Nonwoven

Spunlace, or hydroentanglement, uses high-pressure water jets to entangle fibers into a coherent nonwoven sheet. Spunlace describes the bonding process rather than a specific fiber composition; viscose, polyester, cotton, wood pulp or blends may be used.

Wet Wipes Fundamentals
U.S. FDA Cosmetic GMP

The U.S. FDA publishes Cosmetic GMP Guidelines/Inspection Checklist to guide and inspect cosmetic manufacturers' production and quality management practices concerning premises, personnel, equipment, raw materials, production, laboratory controls and records. FDA states that strict adherence to GMP helps reduce the risk of adulteration or misbranding of cosmetics.

Factory Qualifications
Wipe Folding / Folding Pattern

Wipe folding is the structure used to fold and stack wipes after cutting. Z-fold, C-fold, V-fold and interfold arrangements affect pack volume, single-wipe unfolding and dispensing. Interfold can create a pop-up dispensing effect.

Wet Wipes Fundamentals
Wipe Solution / Impregnation Liquid

The impregnation liquid is the liquid system applied to or absorbed by the substrate during wet wipe manufacturing. Its water base and functional ingredients support cleansing, care, makeup removal or disinfection according to the intended use.

Wet Wipes Fundamentals
Wipe Substrate / Substrate

A wipe substrate is the sheet material that forms the body of a wet wipe and carries the liquid composition. Substrate and liquid work together to determine softness, strength, absorbency and use performance.

Wet Wipes Fundamentals

Definition

References

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“Do You Have a CE Certificate?”