Medical Auditing

TÜVRheinland® performs conformity assessments to all European Medical Device Directives (MDD, IVDD, AIMDD) for CE Marking, including quality system audits, type examinations and batch verifications. Global services include audits and certification for the Canadian Medical Devices Conformity Assessment System (CMDCAS) under our Standards Council of Canada (SCC) accreditation and audits for Japan under TÜVRheinland® Japan’s appointment by the Ministry of Health, Labor and Welfare (MHLW).

Medical Device Directive (MDD)
The Medical Device Directive (MD Directive 93/42/EEC) applies to a wide variety of medical products, including catheters, endoscopes, dental implants and computed tomography systems. First published in 1993, the MDD has been mandatory since 1998, requiring all medical devices sold in the European Union to bear the CE Marking.

In Vitro Diagnostic Device Directive (IVDD)
The In Vitro Diagnostic Device Directive (IVDD Directive 98/79/EC) was first published in 1998, and compliance became mandatory as of December 2003. The IVDD covers the all in vitro diagnostic medical services and corresponding accessories, including HIV tests and blood group-determination devices. TÜVRheinland® is accredited to the full scope of the IVDD.

CMDCAS
TÜVRheinland® is a recognized Canadian Medical Devices Conformity Assessment System (CMDCAS) registrar, having been accredited by the Standards Council of Canada (SCC). It is mandatory that manufacturers of Class II, III or IV medical devices implement the Canadian Medical Devices Regulations (CMDR) into their quality system and, subsequently, achieve registration in accordance with ISO 13485 under the CMDCAS to apply for Canadian device licenses and market devices in Canada.

Active Implantable Medical Device Directive (AIMD)
The Active Implantable Medical Device Directive (AIMD Directive 90/385/EEC) applies to devices such as implantable pacemakers and implantable drug delivery pumps. The directive was published in 1990 and has been mandatory since January 1995.

Japanese Pharmaceutical Affairs Law (PAL)
This law is mandatory for the manufacture and distribution of medical devices and pharmaceutical products in Japan. TÜVRheinland® can assess these requirements through our understanding of manufacturing controls and quality compliance with regard to Japanese Good Manufacturing Practices (GMP).

FDA Third-Party Services
As an Accredited Person (AP) TÜVRheinland® is authorized by the U.S. Food and Drug Administration (FDA) to perform Third-Party reviews and inspections. Under this program, medical device manufacturers can request these Third-Party reviews of 510(k) submissions for eligible devices and request TÜVRheinland® to perform inspections against the U.S. Quality System Regulations.