DECLARATION OF CONFORMITY
DECLARATION OF CONFORMITY
Declaration of Conformity Overview
This document is a formal Declaration of Conformity issued by Medela AG, certifying that their Solo Hands-free product line complies with relevant EU, UK, Swiss, and international regulations concerning electrical safety, electromagnetic compatibility, hazardous substances, radio equipment, waste management, and product safety.
Manufacturer and Product Identification
- Manufacturer: Medela AG
- Address: Lättichstrasse 4b, 6340 Baar, Switzerland
- Products Covered: Various Solo Hands-free models with region-specific adapters (EU, UK, AUS, JP, etc.)
Applicable Directives and Regulations
The products conform to a comprehensive set of directives and regulations, including but not limited to:
- Low Voltage Directive (LVD) 2014/35/EU and UK Electrical Equipment (Safety) Regulation 2016 No. 1101
- Electromagnetic Compatibility (EMC) Directive 2014/30/EU and UK EMC Regulation 2016 No. 1091
- Restriction of Hazardous Substances (RoHS) Directive 2011/65/EU and UK RoHS Regulations 2012 No. 3032
- Radio Equipment Directive (RED) 2014/53/EU, Swiss FuAG law, and UK Radio Equipment Regulation 2017 No. 1206
- Waste Electrical and Electronic Equipment (WEEE) Directive 2012/19/EU and UK WEEE Regulations 2013 No. 3113
- Batteries and Waste Batteries Regulation (EU) 2023/1542 and UK Waste Batteries Regulations 2009 No. 890
- REACH Regulation 1907/2006/EC and UK REACH Regulations
- Dangerous Goods Regulation (DGR)
- General Product Safety Directive 2001/95/EC and upcoming EU General Product Safety Regulation 2023/988
- Market Surveillance and Compliance Regulation 2019/1020/EU
- Packaging and Packaging Waste Directive 94/62/EC
- Waste Directive 2008/98/EC and UK Producer Responsibility Obligations
- Persistent Organic Pollutants Regulation (EU) 2019/1021 and UK POP Regulations
Applied Standards
The products meet harmonized standards ensuring safety, EMC, and environmental compliance, including:
- EN 60335-1:2012+A15:2021 (Safety for household electrical appliances)
- EN 55014-1:2021 and EN 55014-2:2021 (EMC emission and immunity for household appliances)
- EN 55032:2015 + A11:2020 (EMC for multimedia equipment)
- EN 61000-3-2:2020 and EN 61000-3-3:2021 (EMC limits for harmonic currents and voltage fluctuations)
Additional Applicable Standards and Norms
- EN IEC 61558-1:2019 and EN 61558-2-16:2009/A1:2013 (Safety for transformers and power supplies)
- EN 55011:2016/A11:2020 (Radio-frequency disturbance limits)
- EN 62233:2008 (EMF measurement methods for human exposure)
- EN 50106:2008 (Safety and routine tests for household appliances)
- EN 50419:2022 (Marking requirements under WEEE)
- EN 50663:2017 and EN 62479:2010 (Assessment of low power electronic equipment for EMF exposure)
- EN 300 328:2019 and EN 301 489 series (EMC and radio spectrum for data transmission)
- EN IEC 63000:2018 / IEC 63000:2016+AMD1:2022 (Technical documentation for hazardous substances)
Quality Management System
The products are developed and manufactured under an ISO 13485 compliant quality management system, ensuring consistent regulatory compliance and product reliability in the medical device sector.
Compliance Scope and Key Points
- Multiple Solo Hands-free product variants with regional adapters are covered.
- Medela AG assumes full responsibility for conformity with all listed directives and standards.
- Compliance includes both EU and UK regulations, reflecting post-Brexit alignment.
- Environmental directives ensure sustainable lifecycle management, including waste and hazardous substances.
- Comprehensive EMC and electrical safety standards are met.
Declaration Validity and Signatories
- The Declaration of Conformity is valid until December 9, 2027.
- Signed electronically on December 17, 2024, by Judith Bernardo (Global Senior Director Regulatory Affairs / PRRC Deputy) and Thomas Golücke (CEO).
Critical Information and Best Practices
- Adherence to multiple harmonized standards guarantees product safety, EMC, and environmental responsibility.
- ISO 13485 certification supports regulatory compliance and product quality.
- Periodic review and re-certification are required before declaration expiry.
- Multilingual declaration facilitates regulatory acceptance across diverse markets.
Conclusion
This Declaration confirms that Medela AG's Solo Hands-free products comply with stringent EU, UK, and international regulatory requirements, supporting safe market access and consumer protection across multiple jurisdictions.
Catalog excerpts
DECLARATION OF CONFORMITY (EN, DE, FR, IT, NL, ES, PT, EL, RO, HR, SL, PL, SK, HU, LT, LV, ET, CS, BG, RU, SV, DA, NO, FI, AR) KONFORMITÄTSERKLÄRUNG DÉCLARATION DE CONFORMITÉ DICHIARAZIONE DI CONFORMITÀ VERKLARING VAN OVEREENSTEMMING DECLARACIÓN DE CONFORMIDAD DECLARAÇÃO DE CONFORMIDADE ΔΗΛΩΣΗ ΣΥΜΜΟΡΦΩΣΗΣ DECLARAȚIE DE CONFORMITATE IZJAVA O SUKLADNOSTI IZJAVA O SKLADNOSTI DEKLARACJA ZGODNOŚCI VYHLÁSENIE O ZHODE MEGFELELŐSÉGI NYILATKOZAT ATITIKTIES DEKLARACIJA ATBILSTĪBAS DEKLARĀCIJA VASTAVUSDEKLARATSIOON PROHLÁŠENÍ O SHODĚ ДЕКЛАРАЦИЯ ЗА СЪОТВЕТСТВИЕ ДЕКЛАРАЦИЯ СООТВЕТСТВИЯ FÖRSÄKRAN OM ÖVERENSSTÄMMELSE OVERENSSTEMMELSESERKLÆRING SAMSVARSERKLÆRING VAATIMUSTENMUKAISUUSVAKUUTUS إقرار التوافق Manufacturer's Name: Medela AG (Name des Herstellers / Nom du fabricant / Nome del produttore / Naam fabrikant / Nombre del fabricante / Nome do fabricante / Επωνυμία κατασκευαστή / Denumirea producătorului / Naziv proizvođača / Naziv proizvajalca / Nazwa producenta / Meno výrobcu / A gyártó neve / Gamintojo pavadinimas / Ražotāja nosaukums / Tootja nimi / Jméno výrobce / Име на производителя / Название производителя / Tillverkarens namn / Producentens navn / Produsentens navn / Valmistajan nimi, ) اسم الجهة المصنعة Business Address: Lättichstrasse 4b, 6340 Baar, Switzerland (Geschäftsadresse / Adresse commerciale / Indirizzo aziendale / Vestigingsadres / Dirección de la empresa / Endereço commercial / Διεύθυνση επιχείρησης / Adresa comercială / Poslovna adresa / Naslov podjetja / Adres firmy / Miesto podnikania / Székhely / Veiklos adresas / Uzņēmuma adrese / Ettevõtte aadress / Sídlo / Адрес на компанията / Юридический адрес / Företagsadress / Virksomhedsadresse / Selskapets adresse / Yrityksen osoite, ) عنوان المؤسسة التجارية We declare under our sole responsibility, that the following product(s) is (are) in conformity with the requirements of the below mentioned directives/regulations and standards. Wir erklären in eigener Verantwortung, dass die folgenden Produkte den nachstehenden Richtlinien und Normen entsprechen. Nous déclarons, sous notre unique responsabilité, que les produits suivants sont conformes aux directives et normes mentionnées ci-dessous. Dichiariamo sotto la nostra esclusiva responsabilità che i seguenti prodotti sono conformi alle direttive e alle norme di seguito menzionate. Wij verklaren onder onze eigen verantwoordelijkhei
Open the catalog to page 1
DECLARATION OF CONFORMITY (EN, DE, FR, IT, NL, ES, PT, EL, RO, HR, SL, PL, SK, HU, LT, LV, ET, CS, BG, RU, SV, DA, NO, FI, AR) KONFORMITÄTSERKLÄRUNG DÉCLARATION DE CONFORMITÉ DICHIARAZIONE DI CONFORMITÀ VERKLARING VAN OVEREENSTEMMING DECLARACIÓN DE CONFORMIDAD DECLARAÇÃO DE CONFORMIDADE ΔΗΛΩΣΗ ΣΥΜΜΟΡΦΩΣΗΣ DECLARAȚIE DE CONFORMITATE IZJAVA O SUKLADNOSTI IZJAVA O SKLADNOSTI DEKLARACJA ZGODNOŚCI VYHLÁSENIE O ZHODE MEGFELELŐSÉGI NYILATKOZAT ATITIKTIES DEKLARACIJA ATBILSTĪBAS DEKLARĀCIJA VASTAVUSDEKLARATSIOON PROHLÁŠENÍ O SHODĚ ДЕКЛАРАЦИЯ ЗА СЪОТВЕТСТВИЕ ДЕКЛАРАЦИЯ СООТВЕТСТВИЯ FÖRSÄKRAN OM ÖVERENSSTÄMMELSE...
Open the catalog to page 2
DECLARATION OF CONFORMITY (EN, DE, FR, IT, NL, ES, PT, EL, RO, HR, SL, PL, SK, HU, LT, LV, ET, CS, BG, RU, SV, DA, NO, FI, AR) KONFORMITÄTSERKLÄRUNG DÉCLARATION DE CONFORMITÉ DICHIARAZIONE DI CONFORMITÀ VERKLARING VAN OVEREENSTEMMING DECLARACIÓN DE CONFORMIDAD DECLARAÇÃO DE CONFORMIDADE ΔΗΛΩΣΗ ΣΥΜΜΟΡΦΩΣΗΣ DECLARAȚIE DE CONFORMITATE IZJAVA O SUKLADNOSTI IZJAVA O SKLADNOSTI DEKLARACJA ZGODNOŚCI VYHLÁSENIE O ZHODE MEGFELELŐSÉGI NYILATKOZAT ATITIKTIES DEKLARACIJA ATBILSTĪBAS DEKLARĀCIJA VASTAVUSDEKLARATSIOON PROHLÁŠENÍ O SHODĚ ДЕКЛАРАЦИЯ ЗА СЪОТВЕТСТВИЕ ДЕКЛАРАЦИЯ СООТВЕТСТВИЯ FÖRSÄKRAN OM ÖVERENSSTÄMMELSE...
Open the catalog to page 3
DECLARATION OF CONFORMITY (EN, DE, FR, IT, NL, ES, PT, EL, RO, HR, SL, PL, SK, HU, LT, LV, ET, CS, BG, RU, SV, DA, NO, FI, AR) KONFORMITÄTSERKLÄRUNG DÉCLARATION DE CONFORMITÉ DICHIARAZIONE DI CONFORMITÀ VERKLARING VAN OVEREENSTEMMING DECLARACIÓN DE CONFORMIDAD DECLARAÇÃO DE CONFORMIDADE ΔΗΛΩΣΗ ΣΥΜΜΟΡΦΩΣΗΣ DECLARAȚIE DE CONFORMITATE IZJAVA O SUKLADNOSTI IZJAVA O SKLADNOSTI DEKLARACJA ZGODNOŚCI VYHLÁSENIE O ZHODE MEGFELELŐSÉGI NYILATKOZAT ATITIKTIES DEKLARACIJA ATBILSTĪBAS DEKLARĀCIJA VASTAVUSDEKLARATSIOON PROHLÁŠENÍ O SHODĚ ДЕКЛАРАЦИЯ ЗА СЪОТВЕТСТВИЕ ДЕКЛАРАЦИЯ СООТВЕТСТВИЯ FÖRSÄKRAN OM ÖVERENSSTÄMMELSE...
Open the catalog to page 4
DECLARATION OF CONFORMITY (EN, DE, FR, IT, NL, ES, PT, EL, RO, HR, SL, PL, SK, HU, LT, LV, ET, CS, BG, RU, SV, DA, NO, FI, AR) KONFORMITÄTSERKLÄRUNG DÉCLARATION DE CONFORMITÉ DICHIARAZIONE DI CONFORMITÀ VERKLARING VAN OVEREENSTEMMING DECLARACIÓN DE CONFORMIDAD DECLARAÇÃO DE CONFORMIDADE ΔΗΛΩΣΗ ΣΥΜΜΟΡΦΩΣΗΣ DECLARAȚIE DE CONFORMITATE IZJAVA O SUKLADNOSTI IZJAVA O SKLADNOSTI DEKLARACJA ZGODNOŚCI VYHLÁSENIE O ZHODE MEGFELELŐSÉGI NYILATKOZAT ATITIKTIES DEKLARACIJA ATBILSTĪBAS DEKLARĀCIJA VASTAVUSDEKLARATSIOON PROHLÁŠENÍ O SHODĚ ДЕКЛАРАЦИЯ ЗА СЪОТВЕТСТВИЕ ДЕКЛАРАЦИЯ СООТВЕТСТВИЯ FÖRSÄKRAN OM ÖVERENSSTÄMMELSE...
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