European Regulatory Intelligence

UDI
MDCG 2024-14 Guidance on the implementation of the master UDI-DI solution for contact lenses
MDCG 2020-18 MDCG position paper on UDI assignment for Spectacle lenses & Ready readers
MDCG 2021-09 MDCG Position Paper on the Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers
MDCG 2018-3 Rev.1 Guidance on UDI for systems and procedure packs 
MDCG 2018-1 v4  Guidance on basic UDI-DI and changes to UDI-DI
MDCG 2019-1  MDCG guiding principles for issuing entities rules on basic UDI-DI
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
MDCG 2018-4  Definitions/descriptions and formats of the UDI core elements for systems or procedure packs
MDCG 2018-5  UDI assignment to medical device software
MDCG 2018-6  Clarifications of UDI related responsibilities in relation to article 16
MDCG 2018-7  Provisional considerations regarding language issues associated with the UDI database
MDCG 2021-10 The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices
IMDRF/UDI WG/N48 Final:2019 Unique device identification system (UDI system) application guide
MDCG 2021-11 Guidance on Implant Card - "Device types"
MDCG 2021-19 Guidance note integration of the UDI within an organisation's quality management system
MDCG 2022-7 Q & A on the unique device identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746
Commission Delegated Regulation (EU) 2023/2197 amending Regulation (EU) 2017/745 as regards the assignment of unique device identifiers for contact lenses

EUDAMED
Q&A Gradual roll-out of EUDAMED as amended by Regulation (EU) 2024/1860
MDCG 2020-15 MDCG position paper on the use of the EUDAMED actor registration module and of the single registration number (SRN) in the Member States
MDCG 2019-4  Timelines for registration of device data elements in EUDAMED
MDCG 2019-5  Registration of legacy devices in EUDAMED
EUDAMED Actor Module FAQs December 2020 v1.1
MDCG 2021-1 rev.1 Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional
MDCG 2021-13 Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR
2021/2078 Commission Implementing Regulation laying down rules for the application of Regulation (EU) 2017/745 as regards the European Database on Medical Devices (Eudamed)
MDCG 2022-12 Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices)

European Medical Device Nomenclature (EMDN)
MDCG 2024-2 Procedures for the updates of the European medical device nomenclature 
The EMDN – The nomenclature of use in EUDAMED:   01/2020
The CND nomenclature – Background and general principles:  01/2020
MDCG 2021-12 FAQ on European medical device nomenclature (EMDN)
MDCG 2018-2 Future EU medical device nomenclature - Description of requirements

Classification & Qualification
MDCG 2024-11 Guidance on qualification of in vitro diagnostic medical devices
Commission Implementing Regulation (EU) 2022/2347 reclassification of groups of certain active products without an intended medical purpose
MDCG 2023-5 Guidance on qualification and classification of Annex XVI products
MDCG 2023-6 Guidance on demonstration of equivalence for Annex XVI products
MDCG 2021-24 Guidance on classification of medical devices
MDCG 2020-16 rev.3 Guidance on classification rules for in vitro diagnostic medical devices under Regulation (EU) 2017/746
MDCG 2022-5 rev.1 Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices
Manual (Ver.3-September 2023) on borderline and classification for medical devices and IVDs under MDR and IVDR
Helsinki Procedure (Version 23 June 2021) for borderline and classification under MDR/IVDR
MDCG 2019-11 Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746

Post-market Surveillance
Regulation 2019/1020 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011
MDCG 2022-21 Guidance on periodic safety update report (PSUR) according to Regulation (EU) 2017/745 (MDR)
MDCG 2023-3 rev.2 Q& A on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 and Regulation (EU) 2017/746
MDCG 2024-1 Device specific vigilance guidance (DSVG) template
MDCG 2024-1-5 Guidance on the vigilance system for CE-marked devices- DSVG 05 Urogynaecological surgical mesh implants used for pelvic organ prolapse repair and stress urinary incontinence
MDCG 2022-4 rev.2 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

Clinical /Performance Investigation and Evaluation
MDCG 2024-15 Guidance on the publication of clinical investigation reports and their summaries in the absence of EUDAMED
MDCG 2024-10 Clinical evaluation of orphan medical devices 
MDCG 2024-5 Guidance on content of the Investigator’s Brochure for clinical investigations of medical devices
MDCG 2024-3 Guidance on content of the clinical investigation plan for clinical investigations of medical devices
2023/C163/06 Commission guidance on the content and structure of the summary of the clinical investigation report
MDCG 2023-7 Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR
2023/C163/06 Commission guidance on the content and structure of the summary of the clinical investigation report
MDCG 2022-20 Substantial modification of performance study under IVDR 
MDCG 2022-19 Performance study application/notification documents under Regulation (EU) 2017/746  
MDCG 2020-13 Clinical evaluation assessment report template 
MDCG 2020-10/1 Guidance on safety reporting in clinical investigations 
MDCG 2020-10/2 Appendix: Clinical investigation summary safety report form 
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 
MDCG 2019-9 Rev.1 Summary of safety and clinical performance 
MDCG 2022-9 rev.1 Summary of safety and performance template
MDCG 2021-6 rev.1 Regulation (EU) 2017/745 - Questions & Answers regarding clinical investigation 
MDCG 2021-8 Clinical investigation application/notification documents 
MDCG 2021-20 Instructions for generating CIV-ID for MDR Clinical Investigations 
MDCG 2021-28 Substantial modification of clinical investigation under Medical Device Regulation 
MDCG 2022-2 Guidance on general principles of clinical evidence for in vitro Diagnostic medical devices (IVDs) 
MDCG 2022-10 Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)  
MDCG 2020-1  Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software 
MDCG 2019-16 Guidance on cybersecurity for medical devices

Standards
Summary of references of harmonised standards (9 Oct 2024) published in the Official Journal – Regulation (EU) 2017/745
Summary of references of harmonised standards (9 Oct 2024) published in the Official Journal – Regulation (EU) 2017/746
Regulation (EU) 2022/944 Rules for the application of Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the tasks of and criteria for European Union reference laboratories in the field of in vitro diagnostic medical devices 
Commission Implementing Regulation (EU) 2023/1194 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
Commission Implementing Regulation (EU) 2022/2346 Common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745
MDCG 2021-5 rev.1 Guidance on standardisation for medical devices
IMDRF Standards Checklist modified in scope of COVID-19
Commission Implementing Decision (EU) 2021/1182 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745
Commission Implementing Decision (EU) 2022/6 Amending Implementing Decision (EU) 2021/1182 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745
Commission Implementing Decision (EU) 2021/1195 on the harmonised standards for in vitro diagnostic medical devices drafted in support of Regulation (EU) 2017/746
Commission Implementing Decision (EU) 2022/15 Amending Implementing Decision (EU) 2021/1195 on the harmonised standards for in vitro diagnostic medical devices drafted in support of Regulation (EU) 2017/746
2002/364/EC Commission decision of 7 May 2002 on common technical specification for in vitro diagnostic medical devices 
Commission Implementing Decision (EU)  C(2021) 2406 (M/575) on a standardisation request to the CEN and Cenelec as regards medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
Commission Implementing Regulation (EU) 2022/1107 Common specification for certain class D IVDs in accordance with Regulation (EU) 2017/746
Commission Implementing Regulation (EU) 2023/2713 Designating EU reference laboratories in the field of in vitro diagnostic medical devices

Specific in vitro diagnostic medical device guidance
MDCG 2024-4 Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746
European Union reference laboratories (EURLs) in the field of in vitro diagnostic medical devices- Information pack for candidate laboratories
MDCG 2022-15 Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD
MDCG 2021-14 Explanatory note on IVDR codes
MDCG 2021-4 rev.1 Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746
MDCG 2021-22 rev.1 Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746
February 2022 Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
Regulation (EU) 2022/112 Amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices
MDCG 2022-3 Rev.1 Verification of manufactured class D IVDs by notified bodies
MDCG 2022-8 Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC 
MDCG 2022-6 Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR 
Notice to Stakeholders: Status of the EU-Switzerland mutual recognition agreement (MRA) for in vitro diagnostic medical devices

COVID-19
MDCG 2021-2 Guidance on state of the art of COVID-19 rapid antibody tests
MDCG 2021-7 Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical device
MDCG 2021-21 rev.1 Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices
MDCG 2022-1 Notice to third country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices
COVID-19 TESTS Q&A on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19
April 2020 Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context
April 2020 Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19
2020/C122I/01 Guidelines on Covid-19 in vitro diagnostic tests and their performance

Other topics
MDCG 2024-16 Manufacturer Information Form on interruption or discontinuation of supply of certain medical devices and certain IVDs (as per Art. 10a of Regulation 2024/1860)
Q&A Information obligation regarding interruption or discontinuation of supply of certain medical devices and IVDs as introduced by Regulation (EU) 2024/1860
MDCG 2023-4 guidance on medical device software (MDSW) intended to work in combination with hardware or hardware components
Flowchart to assist in deciding whether or not a device is covered by the extended MDR transitional period acc. to Article 120, as amended by Regulation (EU) 2023/607
Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 Extension of the MDR transitional period and removal of the "sell off" periods
MDCG 2023-1 Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
Add 1. MDCG 2022-18 MDCG Position Paper on on the application of Art.97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate
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
MDCG 2022-16 Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746
MDCG 2021-3 Questions and answers on custom-made devices
MDCG 2020-9  Regulatory requirements for ventilators and related accessories
MDCG 2019-3 v.1  Interpretation of article 54(2)b
MDCG 2020-2 rev.1  Class I Transitional provisions under Article 120 (3 and 4) – (MDR)
MDCG 2019-8 v2  Guidance document implant card on the application of Article 18 Regulation (EU) 2017/745 on medical devices
MDCG 2019-15, rev.1  Guidance notes for manufacturers of class I medical devices
MDCG 2019-07 rev.1  Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC)
SCHEER guidelines  Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties
CAMD FAQ CAMD MDR/IVDR Transition Subgroup: FAQ - MDR Transitional provision
MDCG 2021-23 Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
EMA Guidance Q & A for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the medical devices and in vitro diagnostic medical devices regulations (EU) 2017/745 and (EU) 2017/746
MDR/IVDR Language Requirements
MDCG 2021-25 Rev.1 Regulation (EU) 2017/745 - application of MDR requirements to legacy devices and to devices placed on the market prior to 26 May 2021 in accordance with AIMDD and MDD
MDCG 2021-26 Questions and answers on repackaging & relabeling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
14 October 2021 Questions and answers on the progressive roll-out of the new in vitro diagnostic medical devices regulation
MDCG 2021-27 Rev.1 Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 
2021/2226 Commission implementing Regulation laying down rules for the application of Regulation (EU) 2017/745 as regards electronic instructions for use of medical devices
COM(2022) 182 final Commission Report on the exercise of the power to adopt delegated acts conferred on the Commission pursuant to EU MDR and EU IVDR

Notified bodies
MDCG 2024-12 CAPA plan assessment: guidance and templates for conformity assessment bodies, notified bodies, designating authorities and joint assessment teams
MDCG 2024-9 Preliminary re-assessment review (PRAR) form template (IVDR)
MDCG 2024-8 Preliminary assessment review (PAR) form template (IVDR)
MDCG 2024-7 Preliminary assessment review (PAR) form template (MDR)
MDCG 2024-6 Preliminary re-assessment review (PRAR) form template (MDR)
MDCG 2022-17 MDCG position paper on hybrid audits
MDCG 2022-14 Transition to the MDR and IVDR- Notified body capacity and availability of medical devices and IVDs
MDCG 2022-13 rev.1 Designation, re-assessment and notification of conformity assessment bodies and notified bodies
MDCG 2020-17 Questions and Answers related to MDCG 2020-4 "Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions"
MDCG 2020-14 Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under MDR/IVDR
MDCG 2020-12 Guidance on transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product and which has action ancillary to that of the device, as well as on devices manufactured using TSE susceptible animal tissues
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 amending Commission Implementing Regulation (EU) 920/2013   
MDCG 2020-4  Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions
MDCG 2020-3 rev.1  Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD
MDCG 2019-14  Explanatory note on MDR codes
MDCG 2019-13  Guidance on sampling of devices for the assessment of the technical documentation
MDCG 2019-12  Designating authority's final assessment form: Key information (EN)
MDCG 2019-10 rev.1  Application of transitional provisions concerning validity of certificates issued in accordance to the directives
MDCG 2019-6 v4  Questions and answers: Requirements relating to notified bodies
MDCG 2018-8  Guidance on content of the certificates, voluntary certificate transfers
NBOG BPG 2017-1  Best practice guidance on designation and notification of conformity assessment bodies
NBOG BPG 2017-2  Best practice guidance on the information required for personnel involved in conformity assessment
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)
NBOG F 2017-2  Application form to be submitted by a conformity assessment body when applying for designation as a notified body under the in vitro diagnostic devices regulation (IVDR)
NBOG F 2017-3  Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR)
NBOG F 2017-4  Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR)
NBOG F 2017-5  Preliminary assessment review template (MDR)
NBOG F 2017-6  Preliminary assessment review template (IVDR)
NBOG F 2017-7  Review of qualification for the authorisation of personnel (MDR)
NBOG F 2017-8  Review of qualification for the authorisation of personnel (IVDR)
2017/2185/EU Commission Implementing Regulation on the list of codes and corresponding types of devices for the purpose of specifying the scope of
the designation as notified bodies under MDR and IVDR

MDSAP 
MDSAP AU G0002.1.004  MDSAP Companion Document
016 MDSAP frequently asked questions

Commission guidance documents
July 2020 Conformity assessment procedures for protective equipment
May 2020 How to verify that medical devices and personal protective equipment can be lawfully placed on the EU market and thus purchased and used - also in the COVID-19 context
June 2020 Guidance on regulatory requirements for medical face masks
2019/939 Commission Implementing Decision designating issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices
2021/0323 (COD) Proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices