New guidance on Legacy Devices and Q&A on Article 16 published by MDCG

Hamburg, 22.10.2021, Timo Janssen

On 21.10 2021 two new guidance documents were published by the MDCG. On the one hand MDCG 2021-25, which refers to legacy devices and how to handle them, and on the other MDCG: 2021-26, a Q&A document that answers the question at which point a distributor/importer must assume the obligations of a manufacturer.

For this purpose, MDCG 2021-25 describes the obligations of economic operators regarding legacy devices. Among other things, the handling of systems containing such products is discussed and the preparation of periodic safety update reports are explained. Additionally, the annex of the Guidance provides an overview of all articles in Regulation (EU) 2017/745 that relate to such devices.

MDCG: 2021-26, on the other hand, answers questions for importers and distributors regarding the requirements set out in Article 16 of Regulation (EU) 2017/745. Examples are used to discuss at which point a distributor/importer must assume the obligations of a manufacturer. Furthermore, explanations are given on how to deal with UDIs and at which point a repackaging of products is considered as relabeling.


10. Norddeutscher Dialog – Veranstaltungsprogramm online

Hamburg, den 4. August 2021, Randolph Stender

Am 23. und 24. September findet in Hamburg der 10. Norddeutsche Dialog statt. Die Teilnehmer profitieren, neben den Fachvorträgen ausgesuchter Referenten, vor allem durch den gemeinsamen Austausch untereinander. Daher sind wir uns alle einig, dass der Norddeutsche Dialog als Präsenzveranstaltung durchgeführt werden soll. Selbstverständlich unter Berücksichtigung aller notwendigen Maßnahmen. Die Sicherheit aller beteiligten Menschen ist uns am wichtigsten.

Hier geht es zum Veranstaltungsprogramm

NSF PROSYSTEM ist wieder Goldsponsor der MedConf 2021

Hamburg, den 4. August 2021, Randolph Stender

Die MedConf 2021 findet vom 19. bis 21. Oktober 2021 in München statt. Die Konferenz mit begleitender Ausstellung ist die etablierteste und wichtigste Networking Plattform der Medizintechnik. Wir freuen uns, auch dieses Jahr als Goldsponsor vor Ort zu sein und die Veranstaltung mit unseren Keynotes und Vorträgen zu unterstützen. Besuchen Sie uns auf unserem Stand und diskutieren mit unseren Fachexperten aktuelle Themen in der Medizintechnik.

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.


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.