MDCG guidance documents

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Every MDCG guidance record published by Orca1, 1000 per page. Each page lists the record id and its name; open a record for key facts, related records and what Orca1 adds.

1. 2023-c-163-06Commission Guidance on the content and structure of the summary of the clinical…
2. article-10a-decision-treeArticle 10a Decision tree
3. CAMD MDR/IVDR Transition Subgroup: FAQ - MDR Transitional provisions
4. Conformity assessment procedures for 3D printing and 3D printed products to be used in a…
5. Conformity assessment procedures for protective equipment
6. COVID-19 TESTS: Q&A on in vitro diagnostic medical device conformity assessment and…
7. Guidance on medical devices, active implantable medical devices and in vitro diagnostic…
8. Guidance on regulatory requirements for medical face masks
9. Guidance on the Version History
10. Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical…
11. Helsinki Procedure for borderline and classification under MDR & IVDR
12. How to verify that medical devices and personal protective equipment can be lawfully…
13. Is your software a Medical Device?
14. Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v2…
15. Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v3…
16. mdcg-2018-1Guidance on basic UDI-DI and changes to UDI-DI
17. mdcg-2018-2Future EU medical device nomenclature - Description of requirements
18. mdcg-2018-3Guidance on UDI for systems and procedure packs
19. mdcg-2018-4Definitions/descriptions and formats of the UDI core elements for systems or procedure…
20. mdcg-2018-5UDI assignment to medical device software
21. mdcg-2018-6Clarifications of UDI related responsibilities in relation to article 16
22. mdcg-2018-7Provisional considerations regarding language issues associated with the UDI database
23. mdcg-2018-8Guidance on content of the certificates, voluntary certificate transfers
24. mdcg-2019-1MDCG guiding principles for issuing entities rules on basic UDI-DI
25. mdcg-2019-10Application of transitional provisions concerning validity of certificates issued in…
26. mdcg-2019-11Qualification and classification of software - Regulation (EU) 2017/745 and Regulation…
27. mdcg-2019-12Designating authority's final assessment form: Key information (EN)
28. mdcg-2019-13Guidance on sampling of devices for the assessment of the technical documentation
29. mdcg-2019-14Explanatory note on MDR codes
30. mdcg-2019-15Guidance notes for manufacturers of class I medical devices
31. mdcg-2019-16Guidance on cybersecurity for medical devices
32. mdcg-2019-2Guidance on application of UDI rules to device-part of products referred to in article…
33. mdcg-2019-3Clinical evaluation consultation procedure exemptions Interpretation of article 54(2)b
34. mdcg-2019-4Timelines for registration of device data elements in EUDAMED
35. mdcg-2019-5Registration of legacy devices in EUDAMED
36. mdcg-2019-6Questions and answers: Requirements relating to notified bodies
37. mdcg-2019-7Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic…
38. mdcg-2019-8Guidance document implant card on the application of Article 18 Regulation (EU) 2017/745…
39. mdcg-2019-9Summary of safety and clinical performance
40. mdcg-2020-1Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device…
41. mdcg-2020-10-1Guidance on safety reporting in clinical investigations Appendix: Clinical investigation…
42. mdcg-2020-10-2Guidance on safety reporting in clinical investigations, Appendix: Clinical investigation…
43. mdcg-2020-11Guidance on the renewal of designation and monitoring of notified bodies under Directives…
44. mdcg-2020-12Guidance on transitional provisions for consultations of authorities on devices…
45. mdcg-2020-13Clinical evaluation assessment report template
46. mdcg-2020-14Guidance for notified bodies on the use of MDSAP audit reports in the context of…
47. mdcg-2020-15MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single…
48. mdcg-2020-16Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation…
49. mdcg-2020-17Questions and Answers related to MDCG 2020-4: “Guidance on temporary extraordinary…
50. mdcg-2020-18MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers
51. mdcg-2020-2Class I transitional provisions under Article 120 (3 and 4) - (MDR)
52. mdcg-2020-3Guidance on significant changes regarding the transitional provision under Article 120 of…
53. mdcg-2020-4Guidance on temporary extraordinary measures related to medical device notified body…
54. mdcg-2020-5Guidance on clinical evaluation - Equivalence
55. mdcg-2020-6Guidance on sufficient clinical evidence for legacy devices Background note on the…
56. mdcg-2020-7Guidance on PMCF plan template
57. mdcg-2020-8Guidance on PMCF evaluation report template
58. mdcg-2020-9Regulatory requirements for ventilators and related accessories
59. mdcg-2021-09MDCG Position Paper on the Implementation of UDI requirements for contact lenses…
60. mdcg-2021-1Guidance on harmonised administrative practices and alternative technical solutions until…
61. mdcg-2021-10The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical…
62. mdcg-2021-11Guidance on Implant Card - Device types
63. mdcg-2021-12FAQ on the European Medical Device Nomenclature ( EMDN )
64. mdcg-2021-13Questions and answers on obligations and related rules for the registration in EUDAMED of…
65. mdcg-2021-14Explanatory note on IVDR codes
66. mdcg-2021-15Application form to be submitted by a conformity assessment body when applying for…
67. mdcg-2021-16Application form to be submitted by a conformity assessment body when applying for…
68. mdcg-2021-17Applied-for scope of designation and notification of a conformity assessment body…
69. mdcg-2021-18Applied-for scope of designation and notification of a conformity assessment body…
70. mdcg-2021-19Guidance note integration of the UDI within an organisation’s quality management system
71. mdcg-2021-2Guidance on state of the art of COVID-19 rapid antibody tests
72. mdcg-2021-20Instructions for generating CIV-ID for MDR Clinical Investigations
73. mdcg-2021-21Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices
74. mdcg-2021-22Clarification on “first certification for that type of device” and corresponding…
75. mdcg-2021-23Guidance for notified bodies, distributors and importers on certification activities in…
76. mdcg-2021-24Guidance on classification of medical devices
77. mdcg-2021-25Application of MDR requirements to " legacy devices " and to devices placed on the market…
78. mdcg-2021-26Q&A on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745…
79. mdcg-2021-27Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU)…
80. mdcg-2021-28Substantial modification of clinical investigation under Medical Device Regulation
81. mdcg-2021-3Questions and Answers on Custom-Made Devices
82. mdcg-2021-4Application of transitional provisions for certification of class D in vitro diagnostic…
83. mdcg-2021-5Guidance on standardisation for medical devices
84. mdcg-2021-5-appendixTransition to the "EU REP" symbol in EN ISO 15223-1
85. mdcg-2021-6Regulation (EU) 2017/745 - Questions & Answers regarding clinical investigation
86. mdcg-2021-7Notice to manufacturers and authorised representatives on the impact of genetic variants…
87. mdcg-2021-8Clinical investigation application/notification documents
88. mdcg-2022-1Notice to 3rd country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices
89. mdcg-2022-10Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal…
90. mdcg-2022-11MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR and IVDR…
91. mdcg-2022-12Guidance on harmonised administrative practices and alternative technical solutions until…
92. mdcg-2022-13Designation, re-assessment and notification of conformity assessment bodies and notified…
93. mdcg-2022-14Transition to the MDR and IVDR - Notified body capacity and availability of medical…
94. mdcg-2022-15Guidance on appropriate surveillance regarding the transitional provisions under Article…
95. mdcg-2022-16Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU)…
96. mdcg-2022-17MDCG position paper on "hybrid audits"
97. mdcg-2022-18MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the…
98. mdcg-2022-18-add-1MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the…
99. mdcg-2022-19Performance study application/notification documents under Regulation (EU) 2017/746
100. mdcg-2022-2Guidance on general principles of clinical evidence for In Vitro Diagnostic medical…
101. mdcg-2022-20Substantial modification of performance study under Regulation (EU) 2017/746
102. mdcg-2022-21Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745
103. mdcg-2022-3Verification of manufactured class D IVDs by notified bodies
104. mdcg-2022-4Guidance on appropriate surveillance regarding the transitional provisions under Article…
105. mdcg-2022-5Guidance on borderline between medical devices and medicinal products under Regulation…
106. mdcg-2022-6Guidance on significant changes regarding the transitional provision under Article 110(3)…
107. mdcg-2022-7Q&A on the Unique Device Identification system under Regulation (EU) 2017/745 and…
108. mdcg-2022-8Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to…
109. mdcg-2022-9Summary of safety and performance template
110. mdcg-2023-1Guidance on the health institution exemption under Article 5(5) of Regulation (EU)…
111. mdcg-2023-2List of Standard Fees
112. mdcg-2023-3Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU)…
113. mdcg-2023-4Medical Device Software (MDSW) - Hardware combinations Guidance on MDSW intended to work…
114. mdcg-2023-5Guidance on qualification and classification of Annex XVI products - A guide for…
115. mdcg-2023-6Guidance on demonstration of equivalence for Annex XVI products - A guide for…
116. mdcg-2023-7Guidance on exemptions from the requirements to perform clinical investigations pursuant…
117. mdcg-2024-1Device Specific Vigilance Guidance (DSVG) Template
118. mdcg-2024-10Clinical evaluation of orphan medical devices
119. mdcg-2024-1-1DSVG 01 on Cardiac ablation
120. mdcg-2024-11Guidance on qualification of in vitro diagnostic medical devices
121. mdcg-2024-1-2DSVG 02 on Coronary stents
122. mdcg-2024-12Corrective and preventive action (CAPA) plan assessment: guidance and templates for…
123. mdcg-2024-1-3DSVG 03 on Cardiac implantable electronic devices (CIEDs)
124. mdcg-2024-13Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical…
125. mdcg-2024-1-4DSVG 04 on Breast implants
126. mdcg-2024-14Guidance on the implementation of the Master UDI-DI solution for contact lenses
127. mdcg-2024-1-5DSVG 05 on Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair…
128. mdcg-2024-15Guidance on the publication of the clinical investigation reports and their summaries in…
129. mdcg-2024-16Manufacturer Information Form on Interruption or Discontinuation of Supply of certain…
130. mdcg-2024-16-annexDevice Identification table
131. mdcg-2024-2Procedures for the updates of the EMDN
132. mdcg-2024-3Guidance on content of the Clinical Investigation Plan for clinical investigations of…
133. mdcg-2024-4Safety reporting in performance studies of in vitro diagnostic medical devices under…
134. mdcg-2024-5Guidance on the Investigator’s Brochure content Appendix A of the MDCG 2024-5
135. mdcg-2024-6Preliminary re-assessment review (PRAR) form template (MDR)
136. mdcg-2024-7Preliminary assessment review (PAR) form template (MDR)
137. mdcg-2024-8Preliminary assessment review (PAR) form template (IVDR)
138. mdcg-2024-9Preliminary re-assessment review (PRAR) form template (IVDR)
139. mdcg-2025-1EMDN Ad hoc procedure
140. mdcg-2025-10Guidance on post-market surveillance of medical devices and in vitro diagnostic medical…
141. mdcg-2025-2Summary of EMDN 2024 Submissions and outcome of annual revision
142. mdcg-2025-3EMDN Version History
143. mdcg-2025-4Guidance on the safe making available of medical device software (MDSW) apps on online…
144. mdcg-2025-5Questions & Answers regarding performance studies of in vitro diagnostic medical devices…
145. mdcg-2025-6FAQ on Interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic…
146. mdcg-2025-7MDCG Position Paper: Timelines of the implementation of ‘Master UDI-DI’ to contact lenses…
147. mdcg-2025-8Guidance on the implementation of the Master UDI-DI solution for spectacle frames…
148. mdcg-2025-9Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746 Note: Pilot…
149. mdcg-2026-1Summary of EMDN 2025 Submissions and outcome of annual revision
150. mdcg-2026-22025-2026 Annual Revision Change Log
151. mdcg-2026-32026 EMDN Version History
152. mdcg-2026-4MDCG Position Paper: Management of SS(C)P in EUDAMED after mandatory use
153. mdcg-2026-5Position Paper: UDI assignment between manufacturers and distributors
154. nbog-bpg-2017-1Best practice guidance on designation and notification of conformity assessment bodies
155. nbog-bpg-2017-2Best practice guidance on the information required for personnel involved in conformity…
156. nbog-f-2017-5Preliminary assessment review template (MDR)
157. nbog-f-2017-6Preliminary assessment review template (IVDR)
158. nbog-f-2017-7Review of qualification for the authorisation of personnel (MDR)
159. nbog-f-2017-8Review of qualification for the authorisation of personnel (IVDR)
160. Overview of language requirements for manufacturers of medical devices for the information…
161. Q&A Obligation to inform in case of interruption or discontinuation of supply
162. Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607…
163. Q&A on practical aspects related to the implementation of the extended transitional period…
164. Q&A on practical aspects related to the implementation of the gradual roll-out of Eudamed…
165. Q&A on transitional provisions for products without an intended medical purpose covered by…
166. Questions & Answers for applicants, marketing authorisation holders of medicinal products…
167. The CND nomenclature - Background and general principles
168. The EMDN - The nomenclature of use in EUDAMED
169. Update on the guidelines on the benefit-risk assessment of the presence of phthalates in…