Medical device CE marking

MDCG 2021-22 Clarification on first certification – IVDR

2021-08

On August 18, the European Commission published MDCG 2021-22: 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.

The document can be downloaded in our library

Source: European Commission

MDCG 2021-19 Guidance note integration of the UDI within an organisation’s quality management system

2021-07

The Unique Device Identification (UDI) System should allow the identification of medical devices, facilitate appropriate traceability of medical devices, enhance the effectiveness of the post-market safety-related activities for devices, improve incident reporting, enhance targeting field safety corrective actions, lead to better surveillance, reduce medical errors, and help fight against falsified devices. As such the UDI system is intended to be incorporated into the life-cycle of the device.

Integration of UDI in the Quality Management System

Amongst the applicable MDR/IVDR provisions to be included in the QMS of the manufacturer is Article 10(9)(h)/Article 10(8)(h) ‘verification of the UDI assignments made in accordance with Article 27(3)/24(3) to all relevant devices and ensuring consistency and validity of information provided in accordance with Article 29/26’. When implementing the requirements of the MDR/IVDR related to the QMS, manufacturers should therefore consider how the UDI System and obligations can also be integrated.

The following sections are considered in this MDCG guidance document:

  • Design and Development
  • Product documentation and retention
  • Production and process
  • Serious incidents and field safety corrective actions
  • Purchasing controls
  • Documentation and records
  • Enterprise Resource Planning
  • UDI data to be provided to EUDAMED database

The document can be downloaded in our library

Source: European Commission – MDCG

New forms for Notified Bodies in the scope of the MDR and the IVDR

2021-07

On July 15, the European Commission published 4 new forms for Notified Bodies in the scope of the MDR and the IVDR:

  • MDCG 2021-15: Application form to be submitted by a conformity assessment body when applying for designation as notified body under Regulation (EU) 2017/745 on medical devices (MDR)
  • MDCG 2021-16: Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices regulation (IVDR)
  • MDCG 2021-17: Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR)
  • MDCG 2021-18: Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR)

The documents can be downloaded in our library (see above)

Source: European Commission

MDCG 2021-11 Guidance on Implant Card – Device types

2021-06

According to Article 18 (a) of the MDR, the manufacturer of an implantable medical device shall provide together with the device, information allowing the identification of the device, including the device name, serial number, lot number, the UDI, the device model, as well as the name, address and the website of the manufacturer.

In accordance with the instructions laid out in MDCG 2019-8, the implant card should also indicate a ‘device type’ for the implantable medical device in question.

This document provides a non-exhaustive list of implantable medical ‘device types’ in order to aid manufacturers in allocating an appropriate term for this requested information.

The document can be downloaded in our library

Source: European Commission – MDCG

MDCG 2021-13 Q&A on Actor ID

2021-06

On June 23 the European Commission published 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.

The document can be downloaded in our library

Source: European Commission

Update (Rev. 1) on July 12, 2021

MDCG 2021-12 FAQ on EMDN

2021-06

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

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

The same document can also be found in our library in a different format / layout, published by the European Commission on June 15, 2021.

Source: European Commission