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.


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.