2023-12

On December 12, the MDCG published Revision 1 of guidance 2021-6: Regulation (EU) 2017/745 ̶ Questions & Answers regarding clinical investigations, a document that answers many outstanding questions relating to clinical investigations.

The guidance deals with the fundamental issue of what the general differences and improvements related to clinical investigations are under the MDR as compared with the medical device directives and is broken into sections dealing with the following topics: general questions; modifications; timeline considerations; clinical investigation reports; and arrangements for the transitional period.

The document can be downloaded in our library.

Source: European Commission.

2023-12

On December 6 Regulation 2023/2713 was published in the Official Journal.

When an EU reference laboratory is designated, according to Regulation (EU) 2017/746, class D devices have to undergo a performance verification and batch testing by the EU reference laboratory. To ensure sufficient availability of EU reference laboratory services, the selection board also took into account the collective capacity of the candidate laboratories for performance verification and batch testing.

The document can be downloaded in our library

Source: EUR-Lex

2023-11

The European MDCG has issued a Revision 1 of the position paper timely compliance with MDR and IVDR requirements.

Six years have passed since the adoption of MDR and IVDR and the implementation of the regulations is advancing. The Regulations’ transitional provisions have been amended to give manufacturers and notified bodies more time to conduct the necessary conformity assessment procedures and to avert shortages of devices needed for the EU healthcare systems.

The MDCG calls to manufacturers to transition to the Regulations and submit their applications for certification without further delay.

Currently there are 42 MDR and 12 IVDR Notified Bodies accredited: NANDO database

The document can be downloaded in our library

Source: European Commission

2023-10

In the Official Journal of the European Union of October 20, 2023, Regulation (EU) 2023/2197 was published on amending Regulation (EU) 2017/745 of the European Parliament and of the Council, as regards the assignment of Unique Device Identifiers for contact lenses.

The document can be downloaded in our library

Source: European Commission

2023-10

MDCG 2023-4 Medical Device Software (MDSW) – Hardware combinations: Guidance on MDSW intended to work in combination with hardware or
hardware components.

This guidance intends to examine and provide clarifications on which specific regulatory considerations apply when the hardware or hardware component incorporating the data collection element (camera, electrical/optical sensors etc.) are a medical device or an accessory to a medical device. This guidance also outlines scenarios where the hardware or hardware component incorporating a data collection element are not medical devices or
accessories to a medical device. This guidance does not intend to elaborate on aspects related to the clinical evaluation or cybersecurity for these products, as those are tackled in other guidance.

The document can be downloaded in our library

Source: European Commission

2023-09

The European Commission has published version 3 of the manual on borderline and classification for medical devices under the Medical Devices Regulation and IVD Regulation.

The document can be downloaded in our library

Source: European Commission

2023-09

On September 26, the European Commission published the Q&A on transitional provisions for products without an intended medical purpose covered by Annex XVI of the MDR.

De document can be downloaded in our library

Source: European Commission

2023-09

The IMDRF published the second edition of their guidance document concerning Personalized Medical Devices.

The primary purpose of this IMDRF guidance is to recommend a harmonized approach for the application of existing regulatory pathways to medical devices that are intended for a particular individual, and to identify special considerations for the regulation of each identified category of personalized medical device (PMD). The adoption of consistent, harmonized requirements for such medical devices will underpin a harmonized regulatory approach for controls on these types of medical devices and offer significant benefits to the manufacturer, user, patient, and to Regulatory Authorities (RAs). Eliminating differences between jurisdictions supports global convergence, reduces the cost of gaining regulatory compliance and allows patients and healthcare professionals earlier access to new treatments and technologies. This document includes an overview of some of the considerations and concepts that may be relevant in developing a harmonized assessment approach in future.

The guidance can be downloaded in our library

Source: https://www.imdrf.org/

2023-08

Team-NB members adopted a template agreement specifying the terms of the transfer of the appropriate surveillance activities according to Regulation 2017/745 for legacy devices.

The template transfer agreement can be downloaded in our library

Source: Team-NB

2023-08

On the 23^rd of August the European Commission published a flowchart to assist manufacturers and other relevant actors in deciding whether or not a device is covered by the extended transitional period provided for in Article 120 of Regulation (EU) 2017/745 on medical devices (MDR), as amended by Regulation 2023/607. The flowchart should help to determine the eligibility, conditions and deadlines for the placing on the market or putting into service of certain devices in accordance with Article 120 MDR. The user of the flowchart is advised to consult the text of the MDR, which takes precedence over the flowchart, and the Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607.

The flowchart can be downloaded in our library

Source: European Commission