In Vitro Diagnostic Medical Devices Directive (IVD)

If you plan to market in vitro diagnostic devices in the European Union, the device must comply with the In Vitro Diagnostic Directive (IVDD) 98/79/EC. Eurocert offers a set of services to determine conformity with the In Vitro Diagnostic Devices Directive. Certification requires an audit and assessment of the initial product design and technical documentation against the directive, followed by the correct classification of the device's intended use. Testing of the in vitro diagnostic device is completed with on-site audits of the production facilities and the management system.

Benefits

• Meet legal and regulatory requirements
• Position your products with a competitive, independent third-party certificate
• Reach markets faster with a full-scope set of testing and assessment services
• Benefit from experience, expertise, and a global network across the supply chain.

Our in vitro diagnostic device services: as a notified body, TUV Rheinland companies can help medical devices secure approvals worldwide. We offer a full-scope set of services to assess the conformity of in vitro diagnostic devices.

Steps to obtain in vitro diagnostic device certification. 1. Defining the medical device and its intended use: as the manufacturer, you define the purpose and classification of the in vitro diagnostic device. 2. Product design verification and assessment for products on Annex II, List A: our specialists check whether the product design documentation complies with Directive 98/79/EC in full. If the design verification passes, the certification body issues an EC design examination certificate. 3. Technical documentation review: a technical documentation review is required to verify directive conformity. 3a. Optional pre-audit: the scope of this audit is defined to fit your needs. A detailed report follows the audit findings. 4. Initial certification audit, Stage 1: this audit reviews quality management documents and analyses all required information about the company to confirm readiness for certification. The Stage 1 audit report is issued at the close of the Stage 1 audit. Stage 2: based on the audit plan shared in advance, the specialist assesses whether the company's processes meet the relevant directives and standards. A specialist matched to the product category is assigned to the audit team. The detailed audit report with findings is issued at the close of the visit.

5. Certificate / Approval: if the audit results are positive, approval is issued for the conformity assessment procedure. A surveillance audit is carried out every 12 months. A recertification audit is carried out every 5 years.

6. Declaration of conformity: once the audit closes successfully, you can issue a declaration of conformity for your products and market them with the CE marking, including the notified body's identification number. For in vitro diagnostic devices, you can consult Eurocert specialists.