| 2023/C 163/06 | Commission Guidance on the content and structure of the summary of the clinical investigation report | TR | NA- | 2023-05-01 | -- | |
| Commission Implementing Decision (EU) 2019/1396 | Commission Implementing Decision (EU) 2019/1396 of 10 September 2019 laying down the rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the designation of expert panels in the field of medical devices | R | NA- | 2019-09-10 | -- | |
| Commission Implementing Decision (EU) 2019/939 | Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices | R | NA- | 2019-06-06 | -- | |
| Commission implementing regulation (EU) 2017/2185 | Implementing regulation on the list of codes and corresponding types of devices for the purpose of specifying the scope of designation of a notified body | R | 1 | 2017-11-23 | -- | |
| Commission Implementing Regulation (EU) 2020/1207 | Commission Implementing 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 | R | NA- | 2020-08-19 | -- | |
| Commission Implementing Regulation (EU) 2021/2078 | Commission Implementing 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) | R | NA- | 2021-11-26 | -- | |
| Commission Implementing Regulation (EU) 2021/2226 | Commission Implementing 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 | R | NA- | 2021-12-14 | -- | |
| Commission Implementing Regulation 20222/2346 | Commission Implementing 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. | R | NA- | 2022-12-01 | -- | |
| Commission Implementing Regulation 20222/2347 | Commission Implementing 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 | R | NA- | 2022-12-01 | -- | |
| Commission Implementing Regulation 20222/2347 | Commission Implementing 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 | R | NA- | 2022-12-01 | -- | |
| Commission Implementing Regulation 2023/1194 | COMMISSION IMPLEMENTING 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 | R | NA- | 2023-06-20 | -- | |
| EN 14931 | Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance, safety requirements and testing | P | NA- | 2006-06-01 | -- | |
| EN IEC 81001-5-1 | Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle | G | NA- | 2022-02-01 | -- | |
| EN ISO/IEC 27001 | Information security, cybersecurity and privacy protection - Information security management systems - Requirements | G | NA- | 2023-08-01 | -- | |
| EN-IEC 60601-1 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | G | 3 | 2006-10-01 | -- | A12:2014
A13:2024
A1:2013
A2:2021
AC:2010
|
| EN-IEC 60601-1-11 | Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment | G | NA- | 2015-06-01 | -- | A1:2021
|
| EN-IEC 60601-1-3 | Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard:Radiation protection in diagnostic X-ray equipment | P | NA- | 2008-06-01 | -- | A11:2016
A1:2013
A2:2021
|
| EN-IEC 60601-1-6 | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | G | NA- | 2010-05-01 | -- | A1:2015
A2:2021
|
| EN-IEC 60601-1-8 | Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems | B , G | NA- | 2007-09-01 | -- | A11:2017
A1:2013
A2:2021
AC:2010
AC:2014
|
| EN-IEC 60601-2-1 | Medical electrical equipment - Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV | P | NA- | 2021-07-01 | -- | |
| EN-IEC 60601-2-10 | Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators | P | NA- | 2015-06-01 | -- | A1:2016
|
| EN-IEC 60601-2-18 | Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment | P | NA- | 2015-10-01 | -- | |
| EN-IEC 60601-2-19 | Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators | P | NA- | 2021-07-01 | -- | A1:2024
|
| EN-IEC 60601-2-2 | Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories | P | NA- | 2018-05-01 | -- | |
| EN-IEC 60601-2-20 | Medical electrical equipment -- Part 2-20: Particular requirements for basic safety and essential performance of transport incubators | P | NA- | 2020-10-01 | -- | A1:2024
|
| EN-IEC 60601-2-22 | Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment | P | NA- | 2020-11-01 | -- | |
| EN-IEC 60601-2-23 | Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment | P | NA- | 2015-11-01 | -- | |
| EN-IEC 60601-2-24 | Medical electrical equipment - Part 2-24: Particular requirements for the safety of infusion pumps and controllers | P | NA- | 2015-06-01 | -- | |
| EN-IEC 60601-2-25 | Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs | P | NA- | 2015-10-01 | -- | |
| EN-IEC 60601-2-27 | Medical electrical equipment Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment | P | NA- | 2014-09-01 | -- | |
| EN-IEC 60601-2-28 | Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis | P | NA- | 2019-10-01 | -- | |
| EN-IEC 60601-2-3 | Medical electrical equipment - Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment | P | NA- | 2015-06-01 | -- | A1:2016
|
| EN-IEC 60601-2-33 | Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis | P | NA- | 2010-10-01 | -- | A11:2011
A12:2016
A1:2015
A2:2015
AC:2010
AC:2016-03
|
| EN-IEC 60601-2-34 | Medical electrical equipment - Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment | P | NA- | 2014-07-01 | -- | |
| EN-IEC 60601-2-37 | Medical electrical equipment -- Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment | P | NA- | 2008-02-01 | -- | A11:2011
A1:2015
|
| EN-IEC 60601-2-4 | Medical electrical equipment - Part 2-4: Particular requirements for basic safety and essential performance of cardiac defibrillators | P | NA- | 2011-09-01 | -- | A1:2019
|
| EN-IEC 60601-2-40 | Medical electrical equipment - Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment | P | NA- | 2019-01-01 | -- | |
| EN-IEC 60601-2-41 | Medical electrical equipment -- Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis | P | NA- | 2022-02-01 | -- | |
| EN-IEC 60601-2-43 | Medical electrical equipment - Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures | P | NA- | 2023-02-01 | -- | |
| EN-IEC 60601-2-44 | Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography | P | NA- | 2009-06-01 | -- | A11:2011
A1:2012
A2:2016
|
| EN-IEC 60601-2-45 | Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices | P | NA- | 2011-04-01 | -- | A1:2015
|
| EN-IEC 60601-2-46 | Medical electrical equipment - Part 2-46: Particular requirements for basic safety and essential performance of operating tables | P | NA- | 2019-11-01 | -- | |
| EN-IEC 60601-2-47 | Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems | P | 1 | 2015-06-01 | -- | |
| EN-IEC 60601-2-5 | Medical electrical equipment Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment | P | NA- | 2015-10-01 | -- | |
| EN-IEC 60601-2-50 | Medical electrical equipment -- Part 2-50: Particular requirements for basic safety and essential performance of infant phototherapy equipment | P | NA- | 2021-07-01 | -- | A1:2023
|
| EN-IEC 60601-2-52 | Medical electrical equipment -- Part 2-52: Particular requirements for basic safety and essential performance of medical beds | P | NA- | 2010-04-01 | -- | A1:2015
AC:2011
|
| EN-IEC 60601-2-54 | Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy | P | NA- | 2009-10-01 | -- | A1:2015
A2:2019
AC:2019
|
| EN-IEC 60601-2-57 | Medical electrical equipment - Part 2-57: Particular requirements for basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use | P | NA- | 2011-05-01 | -- | |
| EN-IEC 60601-2-62 | Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound(HITU) equipment | P | NA- | 2015-06-01 | -- | |
| EN-IEC 60601-2-63 | Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment | P | NA- | 2015-06-01 | -- | A1:2019
A2:2021
|
| EN-IEC 60601-2-65 | Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment | P | NA- | 2013-01-01 | -- | A1:2020
A2"2021
|
| EN-IEC 60601-2-66 | Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems | P | NA- | 2020-04-01 | -- | |
| EN-IEC 60601-2-75 | Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment | P | NA- | 2019-11-01 | -- | |
| EN-IEC 60601-2-83 | Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment | H , P | NA- | 2020-05-01 | -- | A11:2021
|
| EN-IEC 62304 | Medical device software - Software life-cycle processes | P | NA- | 2006-07-01 | -- | A1:2015
AC:2008
|
| EN-IEC 62366-1 | Medical devices - Part 1: Application of usability engineering to medical devices | G | NA- | 2015-05-01 | -- | A1:2020
AC:2015
|
| EN-IEC 62464-1 | Magnetic resonance equipment for medical imaging -- Part 1: Determination of essential image quality parameters | G | NA- | 2019-03-01 | -- | |
| EN-IEC 80601-2-26 | Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs | P | NA- | 2020-04-01 | -- | A1:2024
C1:2021
|
| EN-IEC 80601-2-30 | Medical electrical equipment -- Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers | P | NA- | 2019-06-01 | -- | |
| EN-IEC 80601-2-49 | Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors | P | NA- | 2019-11-01 | Replaces 60601-2-49 | |
| EN-IEC 80601-2-58 | Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery | P | NA- | 2015-07-01 | -- | A1:2019
|
| EN-IEC 80601-2-60 | Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment | P | NA- | 2020-04-01 | -- | |
| EN-IEC 80601-2-71 | Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment | P , D | 1 | 2018-07-01 | -- | |
| EN-IEC 80601-2-77 | Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment | P | NA- | 2021-10-01 | -- | A1:2024
|
| EN-IEC 80601-2-78 | Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation | P | NA- | 2020-04-01 | -- | |
| EN-ISO 10993-1 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process | G | NA- | 2020-12-01 | -- | |
| EN-ISO 10993-10 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | G | NA- | 2023-03-01 | -- | |
| EN-ISO 10993-11 | Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | G | NA- | 2018-06-01 | -- | |
| EN-ISO 10993-12 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials | G , H | NA- | 2021-07-01 | -- | |
| EN-ISO 10993-2-17 | Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances | G , H | NA- | 2023-12-01 | -- | |
| EN-ISO 10993-2-18 | Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process | G , H | NA- | 2020-06-01 | -- | A1:2023
|
| EN-ISO 10993-23 | Biological evaluation of medical devices - Part 23: Tests for irritation | G , H | NA- | 2021-04-01 | -- | |
| EN-ISO 10993-4 | Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood | G | NA- | 2017-10-01 | 2017-10 | |
| EN-ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | G | NA- | 2009-07-01 | -- | |
| EN-ISO 10993-7 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals | G | NA- | 2008-11-01 | -- | A1:2022
AC:2009
|
| EN-ISO 10993-9 | Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products | G , H | NA- | 2021-10-01 | -- | |
| EN-ISO 11135 | Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices | G | NA- | 2014-07-01 | -- | A1:2019
|
| EN-ISO 11137-1 | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical device | G , H | NA- | 2015-06-01 | -- | A2:2019
|
| EN-ISO 11137-2 | Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose | G , H | NA- | 2015-06-01 | -- | A1:2023
|
| EN-ISO 11197 | Medical supply units | P | NA- | 2019-12-01 | -- | |
| EN-ISO 14971 | Medical devices - Application of risk management to medical devices | B , H | NA- | 2019-12-01 | -- | A11:2021
|
| EN-ISO 18562-1 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process | G | NA- | 2020-03-01 | -- | |
| EN-ISO 18562-2 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter | G | NA- | 2020-03-01 | -- | |
| EN-ISO 18562-3 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds (VOCs) | G | NA- | 2020-03-01 | -- | |
| EN-ISO 18562-4 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate | G | NA- | 2020-03-01 | -- | |
| EN-ISO 20417 | Medical devices - Information to be supplied by the manufacturer | G | corrected | 2022-04-01 | Replaces EN 1041 | |
| EN-ISO 7396-1 | Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum | P | NA- | 2016-04-01 | -- | A1:2019
|
| EN-ISO 7396-2 | Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems | P | NA- | 2007-05-01 | -- | |
| EN-ISO 80601-2-12 | Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators | P | NA- | 2023-11-01 | -- | |
| EN-ISO 80601-2-13 | Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation | P | NA- | 2022-07-01 | -- | A1:2019
|
| EN-ISO 80601-2-55 | Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors | P | NA- | 2018-03-01 | -- | A1:2024
|
| EN-ISO 80601-2-56 | Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement | P | NA- | 2017-08-01 | -- | A1:2020
|
| EN-ISO 80601-2-61 | Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment | P | NA- | 2019-02-01 | -- | |
| EN-ISO 80601-2-70 | Medical electrical equipment -- Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment | P | NA- | 2020-12-01 | Replaces EN-ISO/IEC 17510-1:2009 | |
| EN-ISO 80601-2-72 | Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients | P | NA- | 2023-07-01 | -- | |
| EN-ISO 80601-2-74 | Medical electrical equipment -- Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment | P | NA- | 2021-08-01 | -- | |
| EN-ISO 80601-2-79 | Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment | P | NA- | 2019-09-01 | -- | |
| EN-ISO 80601-2-80 | Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency | P | NA- | 2019-09-01 | -- | |
| EN-ISO 80601-2-87 | Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators | P | NA- | 2021-05-01 | -- | |
| EN-ISO 9170-1 | Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum | P | NA- | 2020-07-01 | -- | |
| EN-ISO 9170-2 | Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems | P | NA- | 2008-07-01 | -- | |
| EN-ISO/IEC 10079-1 | Medical suction equipment - Part 1: Electrically powered suction equipment | P | NA- | 2022-06-01 | -- | |
| EN-ISO/IEC 11608-4 | Pen-injectors for medical use - Part 4:Requirements and test methods for electronic and electromechanical pen-injectors | P | NA- | 2022-06-01 | -- | |
| EN-ISO/IEC 13485 | Medical devices - Quality management systems - Requirements for regulatory purposes | G , H | NA- | 2016-03-01 | -- | A11:2021
AC:2016
AC:2018
|
| EN-ISO/IEC 14155 | Clinical investigation of medical devices for human subjects - Good clinical practice | B | NA- | 2020-10-01 | -- | |
| EN-ISO/IEC 15004-1 | Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments | G | NA- | 2020-12-01 | -- | |
| EN-ISO/IEC 15004-2 | Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection | G | NA- | 2007-03-01 | -- | |
| EN-ISO/IEC 15223-1 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements | B , H | NA- | 2021-10-01 | Supersedes EN ISO/IEC 15223-1:2012 | |
| EN-ISO/IEC 9360-1 | Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml | G | NA- | 2009-05-01 | -- | |
| EN-ISO/IEC 9360-2 | Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml | G | NA- | 2009-05-01 | -- | |
| MDCG 2018-1 | Guidance on basic UDI-DI and changes to UDI-DI | TR | 4 | 2020-03-16 | -- | |
| MDCG 2018-2 | Future EU medical device nomenclature - Description of requirements | TR | NA- | 2018-03-01 | -- | |
| MDCG 2018-3 | Guidance on UDI for systems and procedure packs | TR | NA | 2018-10-01 | -- | |
| MDCG 2018-4 | Definitions/Descriptions and formats of the UDI core elements for systems or procedure packs | TR | NA | 2018-10-01 | -- | |
| MDCG 2018-5 | UDI Assignment to Medical Device Software | TR | NA | 2018-10-01 | -- | |
| MDCG 2018-6 | Clarifications of UDI related responsibilities in relation to Article 16 | TR | NA | 2018-10-01 | -- | |
| MDCG 2018-7 | Provisional considerations regarding the language issues associated with the UDI database (Annex VI, Part A Section 2 and Part B of the Medical Devices Regulation 2017/745 and the In-Vitro Diagnostic Medical Device Regulation 2017/745 | TR | NA | 2018-10-01 | -- | |
| MDCG 2019-1 | MDCG guiding principles for issuing entities rules on Basic UDI-DI | TR | NA | 2019-01-01 | -- | |
| MDCG 2019-10 | Application of transitional provisions concerning validity of certificates issued in accordance to the directives | TR | 1 | 2019-10-01 | -- | |
| MDCG 2019-11 | Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | TR | NA- | 2019-10-01 | -- | |
| MDCG 2019-12 | Designating authority's final assessment form: Key information (EN) | TR | NA- | 2019-10-01 | -- | |
| MDCG 2019-2 | Guidance on application of UDI rules to device-part of products referred to in Article 1(8), 1(9) and 1(10) of Regulation 745/2017 | TR | NA | 2019-01-01 | -- | |
| MDCG 2019-3 | Interpretation of article 54(2)b | TR | rev1 | 2019-03-01 | -- | |
| MDCG 2019-4 | Timelines for registration of device data elements in EUDAMED | TR | NA- | 2019-04-01 | -- | |
| MDCG 2019-5 | Registration of legacy devices in EUDAMED | TR | NA- | 2019-04-01 | -- | |
| MDCG 2019-6 | Questions and answers: Requirements relating to notified bodies | TR | 4 | 2019-06-01 | -- | |
| MDCG 2019-7 | Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a "person responsible for regulatory compliance" (PRRC) | TR | NA- | 2019-06-01 | -- | |
| MDCG 2019-8 | Medical Devices: Guidance document Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices | TR | NA- | 2019-06-01 | -- | |
| MDCG 2019-9 | Summary of safety and clinical performance | TR | rev 1 | 2019-08-01 | -- | |
| MDCG 2020-1 | Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software | TR | NA- | 2020-03-16 | -- | |
| MDCG 2020-10 | Guidance on safety reporting in clinical investigations
TR | NA- | 2020-05-01 | -- | |
| MDCG 2020-11 | Guidance on the renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC to be performed in accordance with Commission Implementing Regulation (EU) 2020/666 | TR | NA- | 2020-05-01 | -- | |
| MDCG 2020-12 | Guidance on transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product | TR | NA- | 2020-06-01 | -- | |
| MDCG 2020-13 | Clinical evaluation assessment report template | TR | NA- | 2020-07-01 | -- | |
| MDCG 2020-14 | Guidance for notified bodies on the use of MDSAP audit reports | TR | NA- | 2020-12-01 | -- | |
| MDCG 2020-15 | MDCG Position Paper on the use of the EUDAMED actor registration module | TR | NA- | 2020-12-01 | -- | |
| MDCG 2020-17 | Questions and Answers related to MDCG 2020-4: | TR | NA- | 2020-12-01 | -- | |
| MDCG 2020-18 | MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers | TR | NA- | 2020-12-01 | -- | |
| MDCG 2020-2 | Class I Transitional provisions under Article 120 (3 and 4) – (MDR) | TR | NA- | 2020-03-16 | -- | |
| MDCG 2020-3 | Guidance on significant changes regarding the transitional provision | TR | rev. 1 | 2020-03-16 | -- | |
| MDCG 2020-4 | Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions | TR | NA- | 2020-04-01 | -- | |
| MDCG 2020-5 | Guidance on clinical evaluation – Equivalence | TR | NA- | 2020-04-01 | -- | |
| MDCG 2020-6 | Guidance on sufficient clinical evidence for legacy device | TR | NA- | 2020-04-01 | -- | |
| MDCG 2020-7 | Guidance on PMCF plan template | TR | NA- | 2020-04-01 | -- | |
| MDCG 2020-8 | Guidance on PMCF evaluation report template | TR | NA- | 2020-04-01 | -- | |
| MDCG 2020-9 | Regulatory requirements for ventilators and related accessories | TR | NA- | 2020-04-01 | -- | |
| MDCG 2021-1 | Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional | TR | rev 1 | 2021-05-01 | -- | |
| MDCG 2021-10 | The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices | TR | NA- | 2021-06-01 | -- | |
| MDCG 2021-12 | FAQ on the European Medical Device Nomenclature (EMDN) | TR | NA- | 2021-06-01 | -- | |
| MDCG 2021-24 | Guidance on classification of medical devices | TR | NA- | 2021-10-01 | -- | |
| MDCG 2021-25 | Application of MDR requirements to "legacy devices" and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC | TR | NA- | 2021-10-01 | -- | |
| MDCG 2021-26 | Q&A on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | TR | NA- | 2021-10-01 | -- | |
| MDCG 2021-27 | Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | TR | rev. 1 | 2023-12-01 | -- | |
| MDCG 2021-28 | Substantial modification of clinical investigation under Medical Device Regulation | TR | NA- | 2021-12-01 | -- | |
| MDCG 2021-3 | Questions and Answers on Custom-Made Devices | TR | NA- | 2021-03-01 | -- | |
| MDCG 2021-5 | Guidance on standardisation for medical devices | TR | rev 1 | 2024-07-01 | -- | |
| MDCG 2021-6 | Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation | TR | NA- | 2021-04-01 | -- | |
| MDCG 2021-8 | Clinical investigation application/notification documents | TR | NA- | 2021-05-01 | -- | |
| MDCG 2022-11 | MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements | TR | rev. 1 | 2022-06-01 | -- | |
| MDCG 2022-13 | Designation, re-assessment and notification of conformity assessment bodies and notified bodies | TR | rev. 1 | 2024-05-01 | -- | |
| MDCG 2022-14 | Transition to the MDR and IVDR - Notified body capacity and availability of medical devices and IVDs | TR | NA- | 2022-08-01 | -- | |
| MDCG 2022-16 | Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | | NA- | 2022-10-01 | -- | |
| MDCG 2022-17 | MDCG 2022-17 - MDCG position paper on ‘hybrid audits’ | TR | NA- | 2022-12-01 | -- | |
| MDCG 2022-18 | MDCG 2022-18 - MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate | TR | ADD 1 | 2023-06-01 | -- | |
| MDCG 2022-21 | MDCG 2022-21 - Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 | TR | NA- | 2022-12-01 | -- | |
| MDCG 2022-4 | Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD | TR | rev.2 | 2022-02-01 | -- | |
| MDCG 2022-7 | Q&A on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) | TR | NA- | 2022-05-01 | -- | |
| MDCG 2023-2 | MDCG 2023-2 - List of Standard Fees | TR | NA- | 2023-01-01 | -- | |
| MDCG 2023-3 | MDCG 2023-3 - Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices | TR | NA- | 2023-02-01 | -- | |
| MDCG 2023-4 | Medical Device Software (MDSW) – Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware components | TR | NA- | 2023-10-01 | -- | |
| MDCG 2023-5 | Guidance on qualification and classification of Annex XVI products - A guide for manufacturers and notified bodies | TR | NA- | 2023-12-01 | -- | |
| MDCG 2023-6 | Guidance on demonstration of equivalence for Annex XVI products - A guide for manufacturers and notified bodies | TR | NA- | 2023-12-01 | -- | |
| MDCG 2023-7 | Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR | TR | NA- | 2023-12-01 | -- | |
| MDCG 2024-1 | Device Specific Vigilance Guidance (DSVG) Template | TR | NA- | 2024-01-01 | -- | |
 MDCG 2024-10 | Clinical evaluation of orphan medical devices | TR | NA- | 2024-06-01 | -- | |
| MDCG 2024-2 | Procedures for the updates of the EMDN | TR | NA- | 2024-02-01 | -- | |
| MDCG 2024-3 | Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices | TR | NA- | 2024-03-01 | -- | |
| MDCG 2024-5 | Guidance on the Investigator’s Brochure content | TR | NA- | 2024-04-01 | -- | |
| MDCG 2024-6,7,8 | PAR and PRAR templates NB designation | TR | NA- | 2024-05-01 | -- | |
| NBCG-Med Template Confirmation letter | Template for NB - Confirmation letter in the framework of Regulation (EU) 2023/607 | | NA- | 2023-05-24 | -- | |
| NBOG BPG 2017-1 | Designation and notification of conformity assessment bodies | TR | 1 | 2017-11-01 | -- | |
| NBOG F 2017-1 | Application form to be submitted by a conformity assessment body when applying for designation as notified body under the medical devices regulation (MDR) | TR | NA- | 2017-11-01 | -- | |
| NBOG F 2017-3 | Applied - for scope of designation and notification of Conformity Assessment Body - Regulation (EU) 2017-745 (MDR) | TR | NA- | 2017-11-01 | -- | |
| Regulation (EU) 2024/1860 | Amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices | R | NA- | 2024-06-01 | -- | |
| Regulation 2017/745 | Medical Devices Regulation | R | NA- | 2017-05-26 | -- | Corrigendum of 27 December 2019 to Regulation (EU) 2017/745
Corrigendum of 5 May 2019 to Regulation (EU) 2017/745
|
| Regulation 2020/561 | Amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions | R | NA- | 2020-04-23 | Postponement of MDR date of application to 26 may 2021 | |
| Regulation 2023/607 | REGULATION (EU) 2023/607 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices | R | NA- | 2023-03-15 | -- | |
