Relevant regulations (CE)

Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (in a unified structure, which includes the amendments of Regulation (EU) 2020/561 (23 April 2020), Regulation (EU) 2023/502 (1 December 2022) and Regulation (EU) 2023/607 (15 March 2023), as well as the corrigenda of 03.05.2019 and 27.12.2019):   MDR

 

Other implementing regulations related to the MDR:

Commission Implamanting Regulation (EU) 2017/2185 of 23 November 2017 on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council

Commission Implamanting Regulation (EU) 2020/1207 of 19 August 2020 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards common specifications for the reprocessing of single-use devices

Commission Implamanting Regulation (EU) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices

Commission Implamanting Regulation (EU) 2021/2078 of 26 November 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the European Database on Medical Devices (Eudamed)

Commission Implamanting Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices

Commission Implamanting Regulation (EU) 2022/2347 of 1 December 2022 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards reclassification of groups of certain active products without an intended medical purpose

Commission Implamanting Regulation (EU) 2023/1194 of 20 June 2023 amending Implementing Regulation (EU) 2022/2346 as regards the transitional provisions for certain products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council

Implementing decisions related to harmonised standards:

Commission Implamanting Decision (EU) 2021/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council

Commission Implementing Decision (EU) 2022/6 of 4 January 2022 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for biological evaluation of medical devices, sterilisation of health care products, aseptic processing of health care products, quality management systems, symbols to be used with information to be supplied by the manufacturer, processing of health care products and home light therapy equipment

Commission Implementing Decision (EU) 2022/757 of 11 May 2022 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for quality management systems, sterilisation and application of risk management to medical devices

 

Contact details of MDCG documents: https://ec.europa.eu/health/md_sector/new_regulations/guidance_en

 

MDCG related to post-market surveillance system (PMS):

MDCG 2022-21 Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745

 

MDCG documents related to clinical evaluation, SSCP content and post-market clinical follow-up (PMCF):

MDCG 2020-13 Clinical evaluation assessment report template
MDCG 2020-8 Guidance on PMCF evaluation report template
MDCG 2020-7 Guidance on PMCF plan template
MDCG 2020-6 Guidance on sufficient clinical evidence for legacy devices
MDCG 2020-5 Guidance on clinical evaluation – Equivalence    April 2020
MDCG 2019-9-Rev.1 Summary of safety and clinical performance

 

European Medical Device Nomenclature (EMDN):

The CND nomenclature – Background and general principles (az eredeti olasz rendszer felépítését bemutató dokumentum, a CND-re épült az EMDN rendszer)
MDCG 2021-12  FAQ on the European Medical Device Nomenclature (EMDN)
EMDN system availability (with search interface): https://webgate.ec.europa.eu/dyna2/emdn/

 

Guidance documents for software:

Infographic: Is your software a Medical Device?
MDCG 2019-11 Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746
MDCG 2019-16 rev.1 Guidance on cybersecurity for medical devices
MDCG 2020-1 Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software

 

Contact details of EUDAMED system (for manufacturer registration): https://webgate.ec.europa.eu/eudamed/landing-page#/

Searchable interfaces for EUDAMED modules for economic operators, registered devices and certificates: hhttps://ec.europa.eu/tools/eudamed/#/screen/home