News

21. Benannte Stellen nach MDR

Hamburg, den 20. Juli 2021, Randolph Stender

Als 21. Benannte Stelle ist die Kiwa Cermet Italia S.P.A. aus Cadriano di Granarolo nach der MDR (Medical Device Regulation 2017/745 on medical devices) akkreditiert worden. Damit gibt es jetzt in Italien drei, in Finnland zwei, in den Niederlanden drei und in Deutschland sechs Benannte Stellen. In den folgenden sieben Länder: Slowakei, Ungarn, Norwegen, Frankreich, Schweden, Irland und Kroatien gibt es jeweils eine Benannte Stelle.

NSF PROSYSTEM TechFile Factory has been certified according to EN ISO 13485:2016

Hamburg, 31st March 2021, Janine Budinger

We are pleased to announce that NSF PROSYSTEM TechFile Factory has implemented quality management for the „Assessment, preparation and maintenance of technical documentation of medical devices including accompanying regulatory services“ and has been successfully certified according to EN ISO 13485:2016.
The new Annexes II and III of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on In-Vitro Diagnostica, provide detailed technical documentation requirements for all medical devices.
It is critical to update existing medical device technical documentation to meet the new general safety and performance requirements of the MDR and IVDR.
Due to the high resource requirements for evaluating existing files and then closing gaps, we have developed a flexible and efficient approach. Our TECHFILE team performs an in-depth assessment of MDD or IVD compliant technical documentation, identifies gaps, and provides recommendations to close those gaps. The entire process is supported by our cross-functional team of experts to ensure high quality results.

Our team is also in close contact with notified bodies and regulatory authorities through project work and networking activities, such as workshops and symposia. The result of our service(s) is easy-to-understand, searchable and clearly structured technical documentation for compliance with the Medical Devices Regulation (including for in vitro diagnostic devices) and for acceptance in markets worldwide.

New MDCG guidance on classifying IVD-products for manufacturer, notified bodies and health care providers

Hamburg, 16.11.2020, Dr. Peter Wirthschaft

The European Commission’s Medical Device Coordination Group (MDCG) released its new guidance on the classification of in vitro diagnostics (IVD) devices under the Regulation (EU) 2017/746 (IVDR). The document has been developed by an expert group representing Member State Competent Authorities, commission services, notified bodies and diagnostic industry.
The guidance gives explanations to manufacturers, notified bodies, and health care providers on how to classify IVD devices according to the risk-based classification system of the IVDR. This classification system divides IVD devices in to four classes (A-D) from lowest to highest risk based on their intended purpose and inherent risk profile, which is in contrast to the previous list-based system of the Directive 98/79/EC.
Manufacturers are encouraged to use this guidance for classifying their product before placing it on the market, making it available on the market or putting it into service in the European Union. With examples for each class, the guidance illustrates how prototypical IVD devices may be classified. In particular, examples given for IVD devices used in combination may be helpful to manufacturers of assay/analyzer combinations where the analyzer and its software are intended to run the assay and measure the output.

Updated FDA guidance document for evaluating the biological safety of medical devices

Hamburg, 15 September 2020, Dr. Silvia Georges

Based on the update of the international standard ISO 10993-1 standard in 2018, the FDA has now revised its associated guidance document. The new version of the Use of International Standard ISO 10993-1, „Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process“ replaces the version from June 16, 2016 (G95-1). The purpose of this guideline is to provide further clarification and updated information on the use of the ISO 10993-1 „Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing as Part of a Risk Management Process“ to support submissions to the FDA. In addition, the guidance document also incorporates several new considerations, including the use of risk-based approaches to determine if biocompatibility testing is needed, chemical assessment recommendations, and recommendations for biocompatibility test article preparation for devices with submicron or nanotechnology components and for devices made from in situ polymerizing and/or absorbable materials, which were not previously discussed in G95-1. The updated guidance document can be downloaded here.

Single Registration Number (SRN) by 01.12.2020?!

Hamburg, 19 August 2020, Christoph Petershagen/i>

The Medical Device Coordination Group (MDCG) has release a new guidance document with the title “Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States” (MDCG 2020-15). Within this paper the MDCG describes that, even though the official date of release for EUDAMED will stay at May 2022, the module for registration of economic operators will be available for the competent authorities of the member states by 01 December 2020.
With this it should be possible to register and generate a SRN for every manufacturer, authorized representative, importer and/or producer of systems/procedure packs by December 2020. This is especially important, since this number is mandatory for many documents, like for example the declaration of conformity. However, the date from which the competent authorities will be able to use this system effectively is still unclear. In addition, the aim of this paper is that competent authorities issue the registration exclusively in EUDAMED to prevent double registrations (EUDAMED and national registration).

Link to MDCG 2020-15

EU Commission releases FAQs for the UDI

Hamburg, 12th August 2020, Christoph Petershagen

On Monday (10/08/2020) the European Commission has released an update of their list of frequently asked questions (FAQs) related to the Unique Device Identification (UDI). This document covers not only the requirements of Regulation (EU) 2017/745 on medical devices, but also those of Regulation (EU) 2017/746 on in-vitro diagnostic medical devices. The updates are mainly editorial or related to the extent of the transition phase.

With it the European Commission answers the most frequent questions of this topic, for example “What is the Basic UDI-DI?”, “How should a UDI appear on the label or package of a device?” or “Who are the designated issuing agencies?”. In doing so they provide useful links to existing MDCG guidance and other sources, which allow a more detailed understanding of the topic.

Even if the updates are not that relevant, the document will give you a short and clear overview of the UDI topic. This will help you to implement the UDI in your organization.

LINK

Guidance for the consultation procedure and novel features

Hamburg, 11th August 2020, Christoph Petershagen

On 07/08/2020, the European Union has released the “Commission guidance for the medical devices expert panels on the consistent interpretation of the decision criteria in the clinical evaluation consultation procedure” (2020/C259/02) in the official journal of the European Union, which was announced already in article 106 of Regulation (EU) 2017/745 on medical devices.

The focus of this document is to provide guidance for the expert panels required for the consultation procedure, however, it contains relevant information for manufacturers as well. In particular, the document outlines defined criteria for “novel features” for the first time. This definition is relevant for every manufacturers’ technical documentation, since the regulation requires to name novel features in the documentation in Annex II section 1.2. At the same time the guidance will help manufacturers to understand which changes and new developments might require a consultation procedure acc. to article 54 which should be considered in the manufacturers project planning.

LINK

RAPS – Risk Management Revisited

Hamburg, 18.12.2019, Juliane Celik

Join Oliver P. Christ at the RAPS event Risk Management Revisited on 24 February 2020 in Bern. The future of medical devices is dependent on international Safety Standards, such as IEC 60601-1 (Medical Electrical Equipment/System) and IEC/ISO 14971 (Risk-Management). Learn more about Benefit/Risk assessment, the harmonization of ISO 14971 and the 2nd amendment of IEC 60601-1:2020. For more information click here.

FDA guidance on considering uncertainty in risk-benefit determinations of medical devices

Hamburg, 10.09.2019, Dr. Silvia van Keulen

A final guidance document was issued by the Food and Drug Administration (FDA) describing the approach when considering uncertainty in risk-benefit determinations related to premarket approval applications (PMA), de novo classification and humanitarian device exemption (HDE) applications. The FDA believes that the described approach „promotes the public health by helping patients have timely access to new medical devices meeting the applicable statutory standard for safety and effectiveness, such that probable benefits of device use outweigh the probable risks and the device will provide clinically significant results in a significant portion of the target population, based on the totality of the valid scientific evidence.“ Several factors are under consideration including the extent of probable risks, benefits, uncertainties and public health needs as well as the patient’s perspective or probable benefits of earlier patient access to the device.

You can access the final guidance document here and if you still want to get more information, the FDA will host a webinar on the guidance.