Dekra notified body With notified bodies for lifts located in Germany, Sweden and France, DEKRA provides conformity assessment according to the Lift Directive within Europe and offers EU-type examinations for lifts. High acceptance and recognition: Both the DEKRA brand and our certifications enjoy high acceptance and recognition in many markets around the world. (NB 0344) to provide services to companies involved in the design, manufacturing, and distribution of medical devices, including high-risk and innovative medical devices and in-vitro diagnostic medical devices. DEKRA has been a Notified Body for over 25 years, and our issued CE marks can be identified by the number 0344 following the CE logo. undefined undefined Aug 23, 2024 · Since DEKRA will become a notified body in the future, it will be able to help manufacturers to understand and navigate the regulation. As a notified body for pressure equipment, DEKRA carries out conformity assessments and verifications related to the following directives and the listed assessment modules or audits. 1925–1929 In 1924, the industrialist Hugo Stinnes develops the idea of a voluntary technical monitoring service for motor vehicles. These services can be combined, but that’s not always necessary. The following content is required (as appropriate to your particular application): 4. (Israel) undefined (ec. (NB 0344). ISO 13485 – the internationally recognized standard for quality management in the medical devices industry. 0158 (DEKRA EXAM GmbH) and no. (Concord branch office) DEKRA Certification Inc. Maxwellstraat 49a - Postbus 1416710 BC EDECountry : Netherlands Notified Body number : 0399 Jul 25, 2024 · DEKRA has been designated as a Notified Body to certify electrical products for the Oman and Bahrain markets. global@ dekra . DEKRA has two Notified Bodies for the EU Medical Device Regulation (2017/745, MDR): DEKRA Certification GmbH (NB 0124) and DEKRA Certification B. is now recognized as a Notified Body by the European Commission under the new EU regulation on in-vitro diagnostics (IVDR 2017/746). official language of the Member State in which the notified body is established or in a language acceptable to that body. At DEKRA we provide testing and certification services in nearly 200 countries and regions, and we work with over 100 partners worldwide for local approvals. Two European Notified Bodies: DEKRA Certification GmbH (NB 0124) and DEKRA Certification B. 0344 (DEKRA Certification B. DEKRA is a Notified Body and an independent, accredited institute. Is your product in risk class 1? If so, it doesn’t need inspecting by a Notified Body. V. The DEKRA Notified Body auditor, who is also your contact for the medical directives (AIMDD, MDD & IVDD) CE certification, will be the lead auditor. DEKRA acts as a Certification Body and as a Notified Body according to all major national and international following directives and regulations. Highly respected: DEKRA is a highly respected Notified Body and is recognized for testing and certifying products according to many national and international directives. DEKRA can help you comply with ISO 13485. . Jun 16, 2021 · DEKRA Certification B. Meander 1051 / P. RED type of applications The technical documentation shall make it possible to assess the radio equipment's conformity with the applicable In order to meet the legal requirements and place the product on the market, the manufacturer often needs to involve a Notified Body in the manufacturing process. You can test the product yourself and affix a CE marking on it yourself as well. Batteries are key to the decarbonization process and the EU's shift towards climate neutrality by 2050 which corresponds to an economy with net-zero greenhouse gas emissions. Dec 16, 2019 · Dekra Certification B. Why DEKRA for Medical Device Regulatory Services MDR / IVDR: Two European Notified Bodies: DEKRA Certification GmbH (NB 0124) and DEKRA Certification B. In Oman, DEKRA has been authorized by GSO and the Directorate General for Standards and Metrology (DGSM) to carry out conformity assessment procedures according to the country’s Energy Efficiency requirements and Technical Regulation for Low-Voltage Electrical Equipment and Appliances. , the Netherlands-based notified body of the worldwide product certification firm, is now designated to review products under the European Medical Device Regulation (MDR), per an official listing Saturday in a European Commission database. can act as a notified body to assess whether your product meets the requirements of the IVDR. ), we test, and certify according to: ATEX Directive (2014/34/EU) IECEx Certification Body With a worldwide presence and in-country partners, DEKRA provides the local certification and approval marks that you need to export your products to new markets around the world. Medical Notified Body HQ Netherlands Meander 1051 6825 MJ Arnhem +31 88 96 83009 medical . What is CE certification? The CE (Conformité Européene) marking is the manufacturer’s declaration that a product fulfills relevant regulations and standards, including safety, health, and environmental protection requirements. DEKRA is designated to review the compliance of products to the essential requirements of the MDD (Medical Device Directive) for access to the EU market. Box 51856825 MJ ARNHEM / 6802 ED ARNHEMCountry : Netherlands Notified Body number : 0344 CE 0399 ABOMA B. Tip: initiate your CE marking application for your device under the IVDR well in advance. To fulfill the statutory requirements and ultimately to place the product on the market, a manufacturer frequently needs to involve a notified body in the manufacturing process. *Applicable only to DEKRA Certification B. With DEKRA’s notified body services related to pressure equipment, we help manufacturers to fulfill the mandatory assessment and inspection requirements within the directives for pressure equipment (PED), simple pressure vessels (SPVD) and transportable pressure equipment (TPED). (North Wales branch office) DEKRA Certification Ltd. This further strengthens DEKRA in the field of medical certification. O. (HQ) DEKRA Certification Inc. are performed by the following legal entities: DEKRA Certification B. May 5, 2017 · DEKRA has two Notified Bodies for the EU In-vitro-Diagnostics Regulation (2017/746, IVDR): DEKRA Certification GmbH (NB 0124), which was in October 2019 the first designated Notified Body in Europe for the Regulation, and DEKRA Certification B. The idea is realized on June 30, 1925 with the founding of the Deutsche Kraftfahrzeug-Überwachungs-Verein (German Motor Vehicle Monitoring Association) in Berlin. undefined undefined At DEKRA we provide testing and certification services in nearly 200 countries and regions, and we work with over 100 partners worldwide for local approvals. Nov 14, 2024 · This includes all medical products above Category 1, such as pregnancy tests and toothpaste. eu) MDSAP: DEKRA Certification B. 1. Additionally, DEKRA is a notified body for certification of medical products in the European union and CE-marking of PPE. We are one of the five largest Notified Bodies in the world for companies involved in the design, manufacturing, and distribution of medical devices, including high-risk and innovative medical devices and in-vitro diagnostic medical devices. As a notified body, DEKRA Certification B. (NB 0344) to provide services to companies involved in the design, manufacturing, and distribution of medical devices. can assess whether your product complies with IVDR. View Factsheet DEKRA’s range of medical device services includes two Notified Bodies. In addition, lifts for transport persons or persons and goods that are under regulation of the Machinery Directive also need an EC-type examination by a notified body, if the risk of falling exceeds Notified Body activities by DEKRA Certification B. DEKRA Certification B. With decades of relevant experience and a global support network, DEKRA is ideally placed to provide this service. europa. Find out what steps to take towards CE certification of medical devices according to MDR/IVDR with DEKRA. com Through our European Notified Bodies no. As a Notified Body with the identification number 0124, DEKRA Certification GmbH accompanies conformity assessment procedures for medical devices in accordance with Directive 93/42/EEC, Regulations (EU) 2017/745 and (EU) 2017/746 for companies placing medical devices on the market. In these cases, you will see a number following the CE mark. vekczw wobgg oex jaedph eut zukj frrug xqvac yqdzmqw osgmon