Along with MDR, new Common Specifications, called MDCG Guidelines, have been added to Outsourced documents such as Harmonized Standards, Meddev Guidelines, which Medical Device Manufacturers have based on in the Medical Device Certification processes so far. Medical Device Manufacturers now have to take these Common Specifications into account while ensuring MDR Compliance.
Medical Device Manufacturers with a valid CE Certificate according to the 93/42/EEC Medical Device Directive (MDD) are also obliged to implement some of these Common Specifications.
MDCG=> Medical Device Coordination Group
Each member state; It appoints to the MDCG, for a period of three years, a member specialized in the field of medical devices, which can be subsequently renewed, and an alternate, a member specialized in the field of in vitro diagnostic medical devices, and an alternate.
The Common Specifications are published by this organization to provide a common understanding of the effective and harmonious implementation of the Regulation and how the MDR should be applied in practice.
See. MDCG Guidelines
https://ec.europa.eu/health/md_sector/new_regulations/guidance_en
See. TITCK EU Guidelines/Guidance Documents
https://www.titck.gov.tr/faaliyetalanlari/tibbicihaz/tibbi-cihaz-mevzuati