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The DiGA guidelines for the fast-track procedure for digital health applications (DiGA) according to Section 139e SGB V have been updated (as of October 11, 2023, version 3.4).

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This document (Commission guidance 2023/C 163/06) is intended to provide Commission guidance, in accordance with MDR for the content and structure of the summary of the clinical investigation report.

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The MDCG paper 2023-03 gives information about:

- Scope of the extension of the MDR transitional period

- Evidence of extended transitional period

- Conditions to be fulfilled to benefit from extended MDR transition period

- Appropriate surveillance to be performed by notified bodies

- removal of the ‘sell-off’ period

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The proposal included an extension of the transition period to the Regulation (EU) 2017/745 (MDR) until 31 December 2027 for higher risk devices and until 31 December 2028 for medium and lower risk devices. The aim is to provide more time for the certification of medical devices. Furthermore, the proposal reflects the deletion of the ‘sell-off’ deadlines in the Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). The proposal needs to be adopted by the European Parliament and the Council.

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The main objective of this guidance document is to assist manufacturers to implement the legal requirements laid down in Article 86 MDR. The Periodic Safety Update Report (PSUR) summarises the results and conclusions of the analysis of the post-market surveillance data gathered as a result of the Post-Market Surveillance Plan. Click here for the guide.

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This document aims to achieve a common understanding of and a uniform approach to the application of Article 97 of Regulation (EU) 2017/745 on medical devices (MDR) in situations where a device is not in conformity with the MDR because its certificate issued under Directive 93/42/EEC (MDD) or Directive 90/385/EEC (AIMDD) has expired or expires before issuance of the necessary certificate(s) in accordance with the MDR. Click here for the guide.

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The BfArM has published a non-final version of the DiPA guide (version 0.9, as of 04.11.2022). With the guide, the BfArM offers manufacturers of DiPA in particular, but also users and all other interested parties, a summary of the various regulations that is as comprehensible as possible. Click here for the guide (only german).

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Manufacturers will be able to continue to place CE marked devices on the Great Britain market after 1 July 2023. From July 2024, the transitional arrangements will apply for CE and UKCA marked devices placed on the Great Britain market. From July 1, 2024, medical devices on the UK market must carry the UKCA label. Click here for more information.

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The Association of Medical Ethics Committees has updated and published an updated the curriculum of necessary trainings for physicians who wish to participate in conducting a clinical trial. The updated documents of the curricular trainings can be found here (only in German).

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A revision of MDCG document 2019-9 has been published, which can be used as a guide for the summary of safety and clinical performance of a medical device. The updated MDCG document can be found here.

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The MDCG published their new document 2022-5, which provides guidance on the borderline between medical devices and medicinal products. The document can be viewed here.

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Labquality acquires ARTIMED Medical Consulting GmbH to strengthen its clinical research offering in Europe (press release).

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The newly published MDCG document MDCG 2022-04 mentioned that the periodic safety update reports (PSURs) should be created by manufacturers in accordance with Article 86 MDR until one year after the date of application of the MDR. This will be the 26 May 2021. Manufacturers of Class IIa or higher products are affected.

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The Digital Healthcare Act (Digitale-Versorgung-Gesetz, DVG) came into effect on December 19th 2019 introducing the “app on prescription” as part of healthcare provided to patients. Prerequisite for the above is that a DiGA must have successfully completed the assessment of the Federal Institute for Drugs and Medical Devices (BfArM) leading  to a listing in a directory of reimbursable digital health applications (DiGA directory). With the publication of the guide (English version: 1.0, 7 Aug 2020; German version: 3.0, 2 Dec 2021) to the fast-track procedure, the BfArM offers a summary of the regulations in this regard.

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In the absence of the European database on medical devices (EUDAMED), a template for a notification document has been created (MDCG 2021-28). The template should be used by the sponsor of a clinical investigation to introduce modifications to a clinical investigation that are likely to have a substantial impact on e.g. the safety of the subjects.

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The newly published MDCG 2021-27 presents questions and answers on requirements related to importers and distributors on in vitro diagnostic medical devices (IVDR). The questions covered by the document aim to provide further detail on the operational and practical implementation of Articles 13 and 14 and other related obligations for importers and distributors under the Regulations.

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This document (MDCG 2021-26) presents questions and answers on repackaging & relabelling activities - obligations introduced by Article 16(2) to (4) under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

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The new MDCG document (MDCG 2021-25) explains the application of transitional provisions laid down in Article 120(3) of Regulation (EU) 2017/745 (MDR) and the consequential application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance  with Directives 90/385/EEC or 93/42/EEC.

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The document (MDCG 2021-24) provides a general overview on the impact of the classification of medical devices on different aspects of the device compliance with the legal requirements. The explanations provide some simplified concepts and are not exhaustive.

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This guidance (MDCG 2021-23) is intended to provide assistance to notified bodies to implement requirements established by MDR and IVDR with regard to certification activities to be carried out according to Article 16(4), attesting that the quality management system of the distributor or importer carrying out any of the activities mentioned in points (a) and (b) of Article 16(2) complies with the relevant requirements. This guidance is also addressed to distributors and importers in respect to their quality management system to be certified by a notified body.

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Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746. For class D devices, Article 48(6) of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) establishes the conditions to be applied by the notified body to determine whether it has to consult the expert panel on the performance evaluation report of the manufacturer. These conditions are:

(1) the absence of common specifications for the class D device in question, AND

(2) where it is also the first certification for that type of device.

This guidance (MDCG 2021-22) provides clarification on the meaning of these conditions and on the corresponding procedures to be followed by the notified body.

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The 4^th Corrigendum of the MDR has been published and contains corrections for the German translation of the medical device regulation 2017/745 as well as for other languages. You can find the various corrigenda here.

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Several new MDCG documents were released in July. They concerned questions and answers on obligations and rules for the registration in EUDAMED (2021-13), an explanatory note on IVDR codes (2021-14), the application form a conformity assessment body has to submit when applying for designation as notified body (2021-15), a guidance note on how to integrate the UDI within an organisation’s quality management system (2021-19), and instructions for generating CIV-ID for MDR clinical investigations (2021-20).

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The European Commission issued an adequacy decision which allows personal data to flow freely from the European Union to the United Kingdom. The adequacy decision expires four years after its entry into force but can be renewed afterwards. Data subjects must be informed that the data will be transferred to a third country for which an adequacy decision has been adopted (see more information here).

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The MDCG endorsed the principles laid out under Appendixes E-I of the IMDRF N48 guidance document and in the document MDCG 2021-10, they provide clarifications as to how certain principles and examples outlined in N48 Appendixes E-I apply under the MDR/IVDR.

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This document is intended to provide guidance in relation to: the circumstances where a PMCF study is indicated; the objectives of PMCF Studies; the design and implementation of PMCF studies; and the use of information from PMCF studies. This document does not apply to in vitro diagnostic devices.

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In their newly published MDCG document (MDCG 2021-12), the European Commission offers questions and answers regarding EMDN; e.g. it specifies the creation and key principles.

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In the absence of the European database on medical devices (EUDAMED), a series of clinical investigation application/notification documents have been created to support clinical investigation procedures with respect to MDR.

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As already reported by us, the corrected standard DIN EN ISO 14155 was available for pre-order, now the standard has been officially published (DIN EN ISO 14155:2021-05) and released for purchase. Buyers of the previous version DIN EN ISO 14155:2020-12 receive a free replacement of the current standard.

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The European Commission has published the revision 4 of the MDCG document 2018-1. The changes encompass a deletion of words in the chapter “The Basic UDI-DI” and the addition of the maximum number of reuses in the chapter “Changes of UDI-DI”.

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In their newly published MDCG document (MDCG 2021-6), the European Commission offers questions and answers for the topic “Clinical investigation in accordance with the MDR”. It answers general and specific questions concerning planned and running investigations.

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The European Commission published an MDCG document (MDCG 2021-5), which serves as guidance on different aspects related to standards in the medical devices sector. It is supposed to provide support regarding the requirements laid down in the applicable EU legislation and explain specificities.

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The DIN EN ISO 14155 has been corrected, is supposedly being released in May 2021, and is already available for preordering. Buyers of the previous version DIN EN ISO 14155:2020-12 receive a free replacement of the current standard.

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The European commission presents a helpful graph on this question, which allows developers to assess whether their software classifies as a medical device according to the MDR.

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The German Medical Association released the notification for trainings for investigators, their deputies, and members of the investigational team in clinical investigations according to German Medicinal Products Act (AMG) and Medical Devices Act (MPG). The different curricula contain the necessary content for the training of the members of the investigational team, specific to AMG or MPG. An overview can be found here (only in German).

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With the publication of the new MDCG document 2021-3, the European commission offers questions and answers specific to custom-made medical devices. This link will take you to the MDCG document on the website of the European Commission.

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Until the EUDAMED database is fully functional, this MDCG 2021-1 document shows alternative solutions, techniques, and practices to exchange information. The document is addressed towards manufacturers, notified bodies, and sponsors of clinical investigations.

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The DIN EN ISO 14155:2020 and EN ISO 14155:2020 have been redacted due to a correction and are currently only available for preordering (click here). The ISO 14155:2020-07 is still valid.