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

MDCG Guidance 2019


  • 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 

 

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


MDR Key Changes


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

MDR Notified Bodies


  1. BSI Assurance UK Ltd.           
    see News: "FIRST MDR Notified Body - BSI UK."
  2. TÜV SÜD Product Service GmbH Zertifizierstellen
    see News: "SECOND Notified Body under the MDR - TÜV Süd Germany"
  3. DEKRA Certification GmbH
    see News: "THIRD Notified Body under the MDR - DEKRA Germany"
  4. IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.
    see News: "Notified Body number FOUR under the MDR - IMQ Italy"
  5. TÜV Rheinland LGA Products GmbH
    see News: "FIVE Notified Bodies under the MDR"

LATEST NEWS

IVDR Notified Bodies


  1. DEKRA CERTIFICATION GMBH, Germany

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 2019-10-22