MDR Full Text


Note: the list starts with the latest version:

MDR Acts


Implementing Acts

(An implementing act clarifies the "how" to implement)

Delegating Acts

(A delegating act clarifies the "what" needs to be further specified)

  •  none published

MDR Key Changes


The MDR introduced a lot of changes, the most important are:

MDCG Guidance 2019


  • MDCG 2019-14:
    Explanatory note on MDR codes
  • MDCG 2019-13:
    Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation
  • MDCG 2019-12: 
    Designating authority's final assessment form: Key information (EN)
  • MDCG 2019-11: 
    Guidance on Qualification and Classification of Software 
  • MDCG 2019-10: 
    Application of transitional provisions concerning validity of certificates issued in accordance to
  • MDCG 2019-6v2:
    Questions and answers: Requirements relating to notified bodies
  • MDCG 2019-4: 
    Timelines for registration of device data elements in EUDAMED
  • MDCG 2019-2: 
    Guidance on application of UDI rules to device-part of products
  • MDCG 2019-1
    Guiding principles for issuing entities rules on basic UDI-DI 

MDCG Guidance 2020


  • 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 
    Guidance on PMCF Evaluation Report Template April 2020

  •  MDCG 2020-7 
    Guidance on PMCF Plan Template April 2020

  •  MDCG 2020-6 
    Guidance on Sufficient Clinical Evidence for Legacy Devices  April 2020

  •  MDCG 2020-5 
    Guidance on Clinical Evaluation – Equivalence April 2020

  • MDCG 2020-3

    Guidance on significant changes under Art. 120 MDR 
  • MDCG 2020-2
    Class 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

MDCG Topics


 

The entire LIST OF GUIDANCE DOCUMENTS published by the European Commission can be found on the "DOCS ROOM".


IVDR Full Text


Note: the list starts with the latest version:

LATEST NEWS

IVDR Notified Bodies


  1. DEKRA CERTIFICATION GMBH, Germany
    see News: "FIRST IVDR Notified Body: DEKRA, Germany"
  2. BSI Assurance UK Ltd.
    see News: "SECOND IVDR Notified Body is BSI UK"

EU nomenclature


The EU-Commission plans to use the Italian CND for the technical coding of medical devices for entry into the EUDAMED database as well as for further aspects e.g. for the sampling of the technical documentation.

 

The CND nomenclature will be further aligned with the existing GMDN nomenclature in order to reach further harmonization.

 


(European) UDI


The European Unique device identifier (UDI )composes of two visible parts:

  • Device identifier (UDI-DI)
  • Production Identifier (UDI-PI)

and one non-visible part:

  • Basic UDI-DI (B-UDI-DI)

The B-UDI-DI is never used on the labelling

 

The B-UDI-DI is intended to identify and connect devices with the same intended purpose, risk class and essential design and manufacturing characteristics and is used for reference in:

  • Technical documentation
  • EUDAMED
  • Notified Body Certificates
  • SSCP
  • Free Sales Certificates

UDI Issuing Agencies


  1. GS1 AISBL
  2. Health Industry Business Communications Council (HIBCC)
  3. ICCBBA
  4. Informationsstelle für Arzneispezialitäten — IFA GmbH

READ MORE

UDI Transition


2021-05-26 (UDI Carrier on label) and

2023-05-26 (Direct marking for reusables)

  • Class III products
  • All Implantables

2023-05-26 (UDI Carrier on label) and

2025-05-26 (Direct marking for reusables)

  • Class IIa products
  • Class IIb products

2025-05-26 (UDI Carrier on label) and

2027-05-26 (Direct marking for reusables)

  • Class I products

MDR Transition


For the so called "legacy devices" (Devices being certified by a notified body under the MDD) you may make use of the prolonged transition (sometimes called "grace period") time which is depending on the validity of the existing MDD certificate and will end on 2024-05-26.

The only condition is your "legacy products" are not subject to a change.

If you intend to change the "legacy product" you may have to apply the MDR, depending on the kind of change.

 

For further information please CONTACT us. 

Content of this website was last updated 2020-05-25