Haveitmade 3rd party Certification

About Haveitmade 3rd party Certification

Service Scoping and Legal Limits: Our services operate within defined legal limits, cross-referenced with EU MDR 2017/745, ISO 13485, and IAF requirements on the roles of ISO registrars.

Regulatory Scope and Authorization: • ISO Registrars: While ISO registrars can certify Management Systems for ISO compliance, they are not authorized to issue EU MDR certifications or CE markings for medical devices. • Notified Bodies (NB): Only EU-authorized NBs perform conformity assessments and issue CE markings for devices above Class I, essential for legal market entry in the EU.

Service Focus on Low-Risk Devices: • Our service is tailored to “lowest-risk” (Class I) devices, aligning with MDR requirements. Typically, Class I devices, unless sterile or with a measuring function, do not require NB intervention for CE marking but must meet MDR compliance for non-invasive devices (per Chapter III Classification Rules, such as Rule 1 or Rule 4).

Economic Operators and Supplier Compliance: • Our service fully supports EU MDR Article 93 by assisting in gathering documentation, conducting internal audits, and ensuring traceability across economic operators, including importers, distributors, and critical suppliers. • Manufacturers and importers are aided in maintaining compliance documentation to enable Competent Authorities prompt access to device-related information for both planned and unannounced audits.

Service Limitations: • Our service description clarifies that, while assisting in QMS compliance for Class I devices, it does not replace CE marking activities or act as a substitute for NB-required conformity assessments. • Service limitations on certification issuance are defined under Annex IX (QMS and technical documentation), underscoring that only NBs can provide certification for higher-risk classifications.

By adhering to these legal scoping limits, we ensure compliance support for Class I devices while respecting the defined roles of ISO registrars and NBs

Address

• Headquarters

  UtrechtUtrecht, Netherlands