Medical device CE marking

MDCG 2021-12 FAQ on EMDN – Rev.1

2025-01

On June 4, 2021 the MDCG issued MDCG 2021-12 on FAQ on the European Medical Device Nomenclature (EMDN).

In January 2025 revision 1 became available with restructuring of questions into clear categories
and addition of Questions 7 – 24

First six questions answered regarding EMDN:
1. What is the European Medical Device Nomenclature (EMDN)?
2. How was the EMDN created?
3. What are the key principles of EMDN?
4. How do I gain access to the EMDN?
5. How is the EMDN structured?
6. Which level of the EMDN should I use to assign a term to my device?

The document can be downloaded in our library

Source: European Commission

MDCG 2024-2 Revision 1 published on Procedures for the updates of the European Medical Device Nomenclature

2025-01

The European Medical Device Nomenclature (EMDN), as established by Article 26 of the MDR and Article 23 of the IVDR, will be annually reviewed and updated based on the practical use of the EMDN and feedback from its users.

This document lays out the procedures for the annual revision as well as the procedure for ad-hoc requests requiring an expedited review.

The document can be downloaded in our library.

Source: European Commission

MDCG 2024-6, 7, 8 and 9 – Preliminary (re-)assessment review form templates published

2025-01

On May 15, 2024, there were 4 new MDCG Notified Body preliminary (re-) assessment review form templates published.

On January 10, 2025, the MDCG issued Revision 1 of MDCG 2024-7 and MDCG 2024-8 (PAR templates MDR and IVDR, including Annexes)

The documents can be downloaded in our library:

Source: European Commission

New consolidated MDR available (2025-01-10)

2025-01

The new consolidated MDR is now available on the European Commission website. This is now including article 10A.

Amended by:

– M1: Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020
– M2: Commission Delegated Regulation (EU) 2023/502 of 1 December 2022
– M3: Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023
– M4:  Regulation (EU) 2024/568 of the European Parliament and of the Council of 7 February 2024
– M5:  Regulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024

Corrected by:

Corrigendum, OJ L 117, 3.5.2019, p.  9 (2017/745)
Corrigendum, OJ L 334, 27.12.2019, p.  165 (2017/745)

The consolidated MDR can be downloaded in our library

Source: EUR-Lex

MDCG issued 2023-3 Revision 2: Q&A on vigilance terms and concepts MDR-IVDR

2025-01

This document aims to clarify important terms and concepts that are outlined in Section 2 of Chapter VII of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

Establishing a common understanding of these terms and concepts is necessary for the effective and harmonised implementation of the vigilance requirements under these Regulations.

The document is written for competent authorities, economic operators and other relevant parties. Some of the definitions presented in this document are reintroduced from the Guidelines on a Medical Devices Vigilance System with, where relevant, modifications for alignment with the MDR and IVDR.

Unless quoted directly from the legal text or otherwise specified, the term ‘devices’ will be understood to include medical devices, accessories for medical devices, products listed in Annex XVI of the MDR, in vitro diagnostic medical devices and accessories for in vitro medical devices. Furthermore, references to ‘the Regulations’ should be understood to cover both the MDR and the IVDR.

The document can be downloaded in our library

Source: European Commission

MDCG publishes revision 1 of guidance (2022-3) concerning the verification of manufactured class D IVDs by notified bodies

2024-12

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establishes the requirements for notified bodies involved in the conformity assessment of applicable classes of in vitro diagnostic medical devices (IVDs). Manufacturers must demonstrate that the devices conform to relevant requirements based upon objective evidence and analysis.

In accordance with these conformity assessment procedures, in addition to quality management system and technical documentation assessments, notified bodies are required to verify product batches of class D IVDs in line with Annexes IX and XI of the IVDR. Therefore, to verify the conformity of class D IVDs, manufacturers should forward to notified bodies the reports on tests carried out on each manufactured batch of class D devices. Furthermore, the manufacturer should make available samples of manufactured class D devices or batches of devices to the notified body in accordance with pre-agreed conditions and detailed arrangements.

The notified body involved in the conformity assessment of class D IVDs should request one of the EU reference laboratories (EURLs), as designated by the European Commission, to carry out batch testing on those devices. The EURL should, in turn, inform the notified body about its findings. Following this verification procedure, manufacturers may place class D IVDs on the market unless the notified body communicates to the manufacturer within an agreed timeframe, but not later than 30 days after reception of the samples, any other decision. In the absence of a designated EURL for a device, the requirements relating to EURLs do not have to be applied.

The revision 1 document can be downloaded in our library

Source: European Commission

European Commission issued a Q&A on Gradual Roll-out of EUDAMED

2024-11

It is a Q&A on practical aspects related to the implementation of the gradual roll-out of Eudamed pursuant to the MDR and IVDR, as amended by Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and
transitional provisions for certain in vitro diagnostic medical devices.

The document can be downloaded in our library

Source: European Commission

 

European Commission issues Q&A on Article 10a of the MDR/IVDR

2024-10

It is a Q&A on practical aspects related to the implementation of the Article 10a obligation in case of interruption or discontinuation of supply of certain devices as introduced by Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices.

There are answers to the following 14 questions:

  1. From when does the new Article 10a of the MDR/IVDR apply?
  2. To whom does the obligation to inform of an anticipated interruption or discontinuation of supply of certain devices under Article 10a(1) of the MDR/IVDR apply?
  3. To which “certain devices” does Article 10a(1) of the MDR/IVDR apply?
  4. Who should the manufacturer inform under Article 10a (1) of the MDR/IVDR?
  5. When should a manufacturer inform under Article 10a (1) of the MDR/IVDR?
  6. What is meant by “exceptional circumstances” in Article 10a (1) second subparagraph of the MDR/IVDR?
  7. What is meant by the “anticipation of an ‘interruption or discontinuation’ of the supply of a device” as outlined in Article 10a (1) of the MDR or IVDR?
  8. What are the categories of reasons for the interruption or discontinuation which the manufacturer would be expected to specify in its notification to the competent authority under Article 10a (1) of the MDR/IVDR?
  9. What is considered as an ‘interruption or discontinuation that may result in serious harm or a risk of serious harm to patients or public health’ in one or more Member States under Article 10a (1) of the MDR/IVDR?
  10. Is the information provided to the competent authority subject to Article 109 MDR/102 IVDR?
  11. How should the information to the competent authority under Article 10a be provided?
  12. Which information should be included in the ‘Manufacturer Information Form’2 for notification to the competent authority under Article 10a?
  13. What is the responsibility of other economic operators in the supply chain under Article 10a(3) of the MDR and IVDR after receiving the information from the manufacturer?
  14. Does Article 10a of the MDR/IVDR apply to system or procedure packs?

The Q&A can be downloaded in our library.

Source: European Commission