Medical device CE marking

2023/2713: Regulation on designating European Union reference laboratories in the field of in vitro diagnostic medical devices

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

Notice to manufacturers to ensure timely compliance with MDR requirements

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

MDCG 2023-4 Medical Device Software (MDSW) – Hardware combinations

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

IMDRF: Personalized Medical Devices – Regulatory Pathways

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/

Newly released flowchart to assist in deciding whether or not a device is covered by the extended MDR transitional period

2023-08

On the 23rd 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