RegulaBase

LINK BASE

Medical devices regulations (EU)
Medical Devices Regulation (EU 2017/745) - MDR consolidated version C2 (forthcoming legislation)
Regulation (EU) 2020/561 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of its certain provisions
In vitro Diagnostic Medical Devices Regulation (EU 2017/746) - IVDR (forthcoming legislation)
Medical Devices Directive (93/42/EEC) - MDD consolidated version M5
In vitro Diagnostic Medical Devices Directive (98/79/EC) - IVDMD consolidated version M3/C2
Active Implantable Medical Devices Directive (90/385/EEC) - AIMDD consolidated version M4/C1
EU Commission guidance documents concerning medical devices
Guidance on regulatory requirements for medical face masks
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
Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context
Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19
The European Medical Device Nomenclature (EMDN) - the nomenclature of use in EUDAMED
The CND Nomenclature - background and general principles
MDCG - Medical Device Coordination Group - guidance documents (limited selection)
(web page)
MDCG 2020-18, MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers
MDCG 2020-17 Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions
MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
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 2020-13 Clinical evaluation assessment report template
MDCG 2020-10/1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745
MDCG 2020-10/2 Clinical Investigation Summary Safety Report Form v1.0
MDCG 2020-9 Regulatory Requirements for Ventilators and Related Accessories
MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies
MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies
MDCG 2020-6 Guidance on sufficient clinical evidence for legacy devices
MDCG 2020-5 Clinical Evaluation - Equivalence. A guide for manufacturers and notified bodies
MDCG 2020-3 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 2020-2 rev. 1Class I Transitional provisions under Article 120 (3 and 4) – (MDR)
MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software
MDCG2019-16 rev.1 Guidance on Cybersecurity for medical devices rev
MDCG 2019-15 rev.1 Guidance notes for manufacturers of class I medical devices
MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR
MDCG 2019-9 Summary of safety and clinical performance A guide for manufacturers and notified bodies - August 2019
MDCG 2019-8 v2 - Guidance document - Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 on medical devices
MDCG 2019-7 Guidance on article 15 of the MDR and IVDR on a ‘person responsible for regulatory compliance’ (PRRC)
MDCG 2019-5 Registration of legacy devices in EUDAMED
MDCG 2019-4 Timelines for registration of device data elements in EUDAMED
MDCG 2019-3 Rev.1 Interpretation of Article 54(2)b (Clinical evaluation consultation procedure for certain class III and class IIb devices)
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 2019-1 MDCG guiding principles for issuing entities rules on basic UDI-DI
MDCG 2018-7 Provisional considerations regarding language issues associated with the UDI database
MDCG 2018-6 Clarifications of UDI related responsibilities in relation to article 16
MDCG 2018-5 UDI assignment to medical device software
MDCG 2018-4 Definitions/descriptions and formats of the UDI core elements for systems or procedure packs
MDCG 2018-3 rev 1. Guidance on UDI for systems and procedure packs
MDCG 2018-2 Future EU medical device nomenclature - Description of requirements
MDCG 2018-1 v3. Guidance on basic UDI-DI and changes to UDI-DI
MEDDEVs - EU Medical devices guidance documents
(web page)

2.1 Scope, field of application, definition

MEDDEV 2.1/1 Definitions of 'medical devices', 'accessory' and 'manufacturer'
MEDDEV 2.1/2 rev.2 Field of application of directive 'Active Implantable Medical Devices'
MEDDEV 2.1/2.1 Treatment of computers used to program implantable pulse generators (field of AIMD)
MEDDEV 2.1/3 rev.3 Borderline products, drug-delivery products and medical devices incorporating, as integral part, an ancillary medicinal substance or an ancillary human blood derivative
MEDDEV 2.1/4 Interface with other directives –Medical devices Directive 89/336/EEC relating to electromagnetic compatibility and Directive 89/686/EEC relating to personal protective equipment
INTERPRETATION DOCUMENT in addition to MEDDEV 2.1/4
MEDDEV 2.1/5 Medical devices with a measuring function
MEDDEV 2.1/6 Qualification and classification of stand alone software

2.2 Essential requirements

MEDDEV 2.2/1 rev.1 Electromagnetic Compatibility (EMC) requirements
MEDDEV 2.2/3 rev.3 “Use by”-date
MEDDEV 2.2/4 Conformity assessment of In Vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) products

2.4 Classification of Medical Devices

MEDDEV 2.4/1 rev.9 Classification of Medical Devices

2.5 Conformity assessment procedure

MEDDEV 2.5/3 rev.2 Subcontracting quality systems related
MEDDEV 2.5/5 rev.3 Translation procedure
MEDDEV 2.5/6 rev.1 Homogenous batches (verification of manufacturers' products)
MEDDEV 2.5/7 rev.1 Conformity assessment of breast implants
MEDDEV 2.5/9 rev.1 Evaluation of medical devices incorporating products containing natural rubber latex
MEDDEV 2.5/10 Guideline for Authorised Representatives

2.7 Clinical investigation, clinical evaluation

MEDDEV 2.7/1 rev. 4 Clinical evaluation: a guide for manufacturers and notified bodies under directives 93/42/EEC (MDD) and 90/385/EEC (AIMDD)
MEDDEV 2.7/1 rev. 4 Appendix 1: Clinical evaluation on coronary stents
MEDDEV 2.7/2 rev. 2 Guidelines for competent authorities for making a validation/assessment of a clinical investigation application under Directives 90/385/EEC (AIMDD) and 93/42/EEC (MDD)
MEDDEV 2.7/3 rev. 3 Clinical investigations: serious adverse event reporting under Directives 90/385/EEC (AIMDD) and 93/42/EEC (MDD)
In relation to MEDDEV 2.7/3 rev.3 - Serious Adverse Event (SAE) reporting form (The new SAE reporting form was taken in use by 1 September 2016.)
MEDDEV 2.7/4 Guidelines on Clinical investigations: a guide for manufacturers and notified bodies

2.10 Notified bodies

MEDDEV 2.10/2 rev.1 Designation and monitoring of Notified Bodies within the framework of EC Directives on Medical devices (AIMDD, MDD, IVMD)
MEDDEV 2.10/2 rev.1 Attachment 1 - Guidance on the preparation of a curriculum vitae for a Medical Device Expert
MEDDEV 2.10/2 rev.1 Attachment 2 - Example of a training course format
MEDDEV 2.10/2 rev.1 Attachment 3 - The responsibilities of the Notified Body under the Medical Device Directives Document
MEDDEV 2.10/2 rev.1 Attachment 4 - Special Rules of accreditation for Certification Bodies of Quality Systems (scope “Sterile Medical Devices”)

2.12 Post-Market surveillance

MEDDEV 2.12/1 rev.8 Market surveillance - Guidelines on a Medical Devices Vigilance System
MEDDEV 2.12/1 rev.8 - Additional Guidance Regarding the Vigilance System
MEDDEV 2.12/2 rev.2 Market surveillance - Post Market Clinical Follow-up studies

2.13 Transitional period

MEDDEV 2.13 rev.1 Commission communication on the application of transitional provision of Directive 93/42/EEC relating to medical devices(OJ 98/C 242/05)
Informative document of the Commission’s services on implementation of directive 2007/47/EC amending directives 90/385/EEC, 93/42/EEC and 98/8/EC

2.14 In-vitro Diagnostic (IVD) Medical Devices

MEDDEV 2.14/1 rev.2 Borderline and Classification issues. A guide for manufacturers and notified bodies
MEDDEV 2.14/2 rev.1 Research Use Only products
MEDDEV 2.14/3 rev.1 Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD) Medical Devices
MEDDEV 2.14/4 CE marking of blood based in vitro diagnostic medical devices for variant Creutzfeldt-Jakob Disease (vCJD) based on detection of abnormal PrP (host protein)

2.15 Other guidance

MEDDEV 2.15 rev.3 Committees/Working Groups contributing to the implementation of the Medical Device

Updated: December 31, 2020.

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