Dekra notified body As a notified body, DEKRA Certification B. DEKRA is active almost everywhere in the world and the members of our medical device team have extensive expertise in a wide array of medical and in vitro devices. 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 is a respected notified body and is recognized for testing and certifying products according to many national and international standards. (HQ) DEKRA Certification Inc. 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. ), we test, and certify according to: ATEX Directive (2014/34/EU) IECEx Certification Body 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). 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 This exchange occurs between EU Notified Body Partners and medical device QMS auditing organizations authorized by the Taiwan Food and Drug Administration (TFDA). Two European Notified Bodies: DEKRA Certification GmbH (NB 0124) and DEKRA Certification B. Box 51856825 MJ ARNHEM / 6802 ED ARNHEMCountry : Netherlands Notified Body number : 0344 CE 0399 ABOMA B. We are the world’s leading Safety Solutions provider with more than 47,000 employees and around €3. Specialized Knowledge. 1. (Israel) undefined (ec. , 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. Meander 1051 / P. 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. The risk class of the device determines whether a test needs to be performed by a Notified Body. global@ dekra . DEKRA Certification GmbH is a notified body and certification body for medical devices. 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. DEKRA is a Notified Body and an independent, accredited institute. DEKRA has two Notified Bodies for the EU Medical Device Regulation (2017/745, MDR): DEKRA Certification GmbH (NB 0124) and DEKRA Certification B. 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. We also provide testing and certification for EMC as a Notified Body under the European Electromagnetic Compatibility directive 2014/30/EU. europa. 0158 (DEKRA EXAM GmbH) and no. ISO 13485 – the internationally recognized standard for quality management in the medical devices industry. The idea is realized on June 30, 1925 with the founding of the Deutsche Kraftfahrzeug-Überwachungs-Verein (German Motor Vehicle Monitoring Association) in Berlin. official language of the Member State in which the notified body is established or in a language acceptable to that body. eu) MDSAP: DEKRA Certification B. A Notified Body is an organisation which has been designated by the government to test and certify the products. CE-Certification of Medical Devices under the MDR/ IVDR DEKRA protects people, assets, and our community by providing comprehensive testing, inspection, certification and consulting services around the globe. DEKRA Testing and Certification GmbHHandwerkstraße 1570565 StuttgartCountry : Germany Notified Body number : 0158 CE 0193 PFI - PRÜF-UND FORSCHUNGSINSTITUT PIRMASENS E. The following content is required (as appropriate to your particular application): 4. (DEKRA) is a Notified Body which is designated in Europe for the MDR (2017/745) and IVDR (2017/746). DEKRA can help you comply with ISO 13485. Medical Notified Body HQ Netherlands Meander 1051 6825 MJ Arnhem +31 88 96 83009 medical . DEKRA is also an ISO 13485 accredited Certification Body and an MDSAP recognized Auditing Organisation. undefined undefined Oct 9, 2024 · One of the key provisions of the AI Act allows Notified Bodies—organizations designated to assess the conformity of medical devices—to conduct combined assessments under both MDR/IVDR and the AI Act. With the combination of these Notified Bodies DEKRA continues to be a reliable, competent partner for its customers in the field of medical device certification and will also offer DEKRA Certification B. . After certification manufacturers can affix CE Mark on their Medical device and are free to market their devices in all EU Member states. With the combination of these Notified Bodies DEKRA continues to be a reliable, competent partner for its customers in the field of medical device certification and will also offer DEKRA has two Notified Bodies for the EU Medical Device Regulation (2017/745, MDR): DEKRA Certification GmbH (NB 0124) and DEKRA Certification B. Notified Body activities by DEKRA Certification B. Usually, the competent authority appoints notified bodies. Through our European Notified Bodies no. (NB 0344). When you work with DEKRA, we share our specialized knowledge and expertise with you. 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. 0344 (DEKRA Certification B. Marie-Curie-Strasse 1966953 PIRMASENSCountry : Germany Notified Body number : 0193 Dec 16, 2019 · Dekra Certification B. com 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. A notified body is an organization that has been accredited by an EU Member State to conduct a conformity assessment under the relevant EU Directives and issue CE certificate. With decades of relevant experience and a global support network, DEKRA is ideally placed to provide this service. (Concord branch office) DEKRA Certification Inc. DEKRA’s range of medical device services includes two Notified Bodies. O. (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. 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. DEKRA Certification B. 1925–1929 In 1924, the industrialist Hugo Stinnes develops the idea of a voluntary technical monitoring service for motor vehicles. As a notified body, DEKRA supports your business continuously, issuing an NB Opinion according to the RED Directive, if applicable. 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. can assess whether your product complies with IVDR. Additionally, DEKRA is a notified body for certification of medical products in the European union and CE-marking of PPE. (North Wales branch office) DEKRA Certification Ltd. However, this is contingent upon these bodies being evaluated and recognized as compliant with the AI Act during the MDR/IVDR notification 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. 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. 4 billion in revenues worldwide. With the combination of these Notified Bodies DEKRA continues to be a reliable, competent partner for its customers in the field of medical device certification and will also offer A notified body is an organization authorized to assess the conformity of certain products before they are placed on the market. Maxwellstraat 49a - Postbus 1416710 BC EDECountry : Netherlands Notified Body number : 0399 DEKRA has been designated as a Notified Body to certify electrical products for the Oman and Bahrain markets. Our experts have extensive experience in a range of certifications, marks, and standards. A notified body is an organization authorized to assess the conformity of certain products before they are placed on the market. DEKRA is authorized as a notified body to assess the conformity of medical products, according to the regulations as described in the IVDR and MDR. These services can be combined, but that’s not always necessary. are performed by the following legal entities: DEKRA Certification B. V. RED type of applications The technical documentation shall make it possible to assess the radio equipment's conformity with the applicable 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. ogqji lhjpk jqcvsq lbiluhh gek fxnbgt uchlq hmuzpx odkrzv fakxm