Common Specifications

With the MDR, new Common Specifications, known as MDCG Guidelines, have been added to the external documents that Medical Device Manufacturers previously relied on during the Medical Device Certification processes, such as Harmonized Standards and Meddev Guidelines. Medical Device Manufacturers must now take these Common Specifications into account while ensuring MDR compliance.

Medical Device Manufacturers holding a valid CE Certificate under the 93/42/EEC Medical Device Directive (MDD) are also required to apply some of these Common Specifications.

MDCG=> Medical Device Coordination Group (MDCG)

Each Member State shall appoint an expert and a substitute in the field of medical devices for a three-year term, which may be renewed, and an expert and a substitute in the field of in vitro diagnostic medical devices.

Common Specifications are published by this body to provide a common understanding of how the Regulation should be applied effectively and consistently, and how the MDR should be practically implemented.

See MDCG Guidelines

https://ec.europa.eu/health/md_sector/new_regulations/guidance_en

See: TİTCK EU Guidelines/Reference Documents

https://www.titck.gov.tr/faaliyetalanlari/tibbicihaz/tibbi-cihaz-mevzuati