Medical DevicesRegulatory Information Management

2. EN ISO 13485 and Medical Device Directive Certification Services


Booth: 440

Much like its counterpart, ISO 13485:2016, EN ISO 13485 requires an organization to conform to the requirements of both the customer and regulatory standards. Originally developed in the 1990s, EN ISO would soon become the harmonized European version of ISO 13485. In 2000, the European Committee for Standardization unified the European version with the international standard. EN ISO 13485 is similar to EN ISO 9001 but it contains added requirements for medical devices. The only difference between ISO 13485 and EN ISO 13485 is that the EN standard is aligned with the Active Implantable Medical Device Directive (AIMDD), Medical Device Directive (MDD), In-Vitro Diagnostic Medical Devices (IVDD) in the annexes of the standard, which have extra requirements for selling medical devices in the European Union. In order for a medical device manufacturer to place a product on the European market, the organization would have to meet the requirements of the Medical Device Directive (MDD). The goal of MDD is to harmonize the regulatory requirements regarding medical devices within the European Union. Products that are conforming to the MDD requirements must have a ‘CE’ mark applied. The ‘CE’ mark is a certification mark that indicates the medical devices conforms to health, environmental protection, and safety standards within the EU. According to MDD, a medical device manufacturer is required to develop a technical documentation package in order to evaluate the compliance of their device against the necessary requirements and to establish a QMS that meets the requirements of the standard. Currently, MDD is being replaced with the Medical Device Regulation (MDR 2017/745). MDR will come into effect on May 26, 2021. The deadline for this standard was delayed a year from 2020 because of the COVID-19 pandemic. TÜV NORD Cert GmbH is in the process of becoming designated for MDR and will begin auditing under this standard once the designation process has been completed. [TUV USA, Inc. also offers a variety of other standards. Please contact us for further information.]

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