GREECE Law and Practice Contributed by: Angela Livgieri, Danai Panopoulou and Iliana Andronou, ALG Manousakis Law Firm
Medical Devices The MDR and the IVDR regulate medical devices. National Joint Ministerial Decisions, along with guidance issued by the EOF, provide additional oversight. Medical devices are designed to assist bodily functions and can operate mechanically, physically, or through software without produc- ing direct pharmacological effects. Examples include surgical instruments and diagnostic soft- ware. Manufacturers must complete a conform- ity assessment to demonstrate compliance with safety and performance standards. The product obtains CE marking through a notified body or the national authority before it can be marketed. Devices are classified based on their risk level and intended purpose, with post-marketing vigi- lance responsibilities ensuring continued safety and effectiveness. In Greece, the responsible notified body for the conformity assessment and the CE marking (granting of CE 0653 in Greece, which shows compliance with the applicable legislation) of medical devices is the National Evaluation Center of Quality and Technology in Health (EKAPTY). 3.2 Granting a Marketing Authorisation for Biologic Medicinal Products In Greece, biologic medicinal products require marketing authorisation through either the national procedure (EOF) or, more commonly, the centralised procedure under Regulation (EC) No 726/2004, where approval is granted at the EMA level. There are no differences in the approval process between pharmaceutical (chemical) and biologi- cal products. Biosimilars, or generic biological products, must be similar but not identical to the reference prod- uct. This contrasts with traditional chemical
pharmaceuticals, which require identical char- acteristics for approval. 3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices Validity and Renewal Pharmaceuticals Marketing authorisations are valid for five years from the date of approval. If a renewal is approved, the authorisation lasts indefinitely unless further safety monitoring is necessary, in which case the renewal is for an additional five- year period. Medical devices A CE certificate necessary for the marketing of medical devices is issued by a notified body for a five-year term (as per Article 56 paragraph 2 of the MDR). Manufacturers must provide updat- ed clinical evaluations, performance data, and post-market surveillance reports to renew the CE certificate. The said CE certificate is issued by a notified body (ie, the organisation respon- sible for the CE certification issuance and con- formity assessment procedures as per Article 1, paragraph 2ie), Article 11 and 16 of the Joint Ministerial Decision DY8d/130648/2009 – their specific requirements are set out in Annex VII of the MDR, in Greece, Ministry of Health is respon- sible for their compliance as per Article 3 of the Ministerial Decision A4g/88159/2017). Revocation, Variation, Suspension or Withdrawal Revocation by EOF or EMA if: • the product is not placed on the market within three years of authorisation; • the product is not marketed for a continuous period of three years; or
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