2021-10
The EUDAMED UDI/Devices and NBs & Certificates modules are open. Economic Operators and Notified Bodies can start entering data in EUDAMED on a voluntary basis.
Source: European Commission
MDCG 2021-24 Guidance on classification of medical devices
2021-10
On October 4 the MDCG published 2021-24: Guidance on classification of medical devices.
The document is divided into 4 chapters:
– Purpose of medical device classification
– Practical relevance of classification
– How to carry out classification
– Explanations of individual rules.
The document can be downloaded in our library
Source: European Commission
Medtech Europe Survey – IVD manufacturer
2021-09
MedTech Europe, the European trade association for the medical technology industry including diagnostics, medical devices and digital health, ran a survey in July 2021 to gather data from IVD manufacturers on the state of the IVD market today and how they are expected to transition to the IVD Regulation within ten months from the survey date. The survey, which represents an estimated 90% market revenue coverage, was commissioned by the Competent Authorities for Medical Devices (CAMD) Task Force on Certification Capacity Monitoring.
Many IVDs are not expected to receive certification by the deadline of 26 May 2022 under the IVD Regulation. The highest proportionate loss of IVDs will come from small and medium sized manufacturers, many of whom make niche products in smaller volumes and who may be more prone to run out of business. From the survey data, an estimated best-case scenario where 61% of today’s IVDs will be certified by 26 May 2022 and a worst-case scenario where only 24% will.
The full survey report may be read here.
CEN and CENELEC announced their new website
2021-09
On September 1st, 2021, the CEN (European Committee for Standardization) and CENELEC (European Committee for Electrotechnical Standardization) announced their new website – www.cencenelec.eu.
The website aims to offer an enhanced user experience: it features a refreshed look, improved navigation and a handful of features which will make the overall experience more impactful on either desktop, mobile or tablet.
Among the relevant features of the website, CEN and CENELEC have worked on centralising and providing targeted information to stakeholders and the general public on sectors, news, and events. Furthermore, a dedicated expert area has been introduced, providing a central access to all CEN and CENELEC support tools and applications.
New standard: EN ISO 20417:2021 Information to be supplied by the manufacturer
2021-08
A new standard has been published concerning the information to be supplied by the manufacturer. This document supersedes EN 1041:2008+A1:2013.
The standard provides content-requirements for medical device labels, packaging and accompanying information.
It can be purchased at: https://www.iso.org/standard/67943.html
MDCG 2021-23 Guidance on certification activities – MDR-IVDR
2021-08
On August 20, the European Union published MDCG 2021-23 – Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746.
The document can be downloaded in our library
Source: European Commission
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 2021-21 Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices
2021-08
On August 3, the European Commission published MDCG 2021-21: Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices.
The document can be downloaded on our library
Source: European Commission
MDCG 2021-20 CIV-ID for MDR Clinical Investigations
2021-07
On July 22nd, the Eurpean Commission published MDCG-2021-20: Instructions for generating CIV-ID for MDR Clinical Investigations.
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
