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Which competent higher federal authority is responsible for the performance study of a companion diagnostic (CDx)? Date: 17. August 2022 Topics: Medical devices Type: FAQ

In Germany, the competent higher federal authorities are responsible for notifications of or applications for approval of performance studies with companion diagnostics (CDx). This is either the Paul Ehrlich Institute (PEI) or the Federal Institute …

Which SAE and DD reporting obligations apply from the date of application of the IVDR in Germany? Date: 17. August 2022 Topics: Medical devices Type: FAQ

Information on SAE and DD reporting requirements can be found in the Applications and Reports section.

What is meant by "in-house developed tests" (sometimes also lab-developed tests or in-house tests) and what are the requirements for them? Date: 17. August 2022 Topics: Medical devices Type: FAQ

The IVDR refers to "devices manufactured and used exclusively within healthcare facilities established in the Union" (Article 5(5) IVDR). A "healthcare establishment" is defined in the IVDR as an organisation whose primary purpose is the care or …

What are the requirements for testing bodies and investigators? Date: 17. August 2022 Topics: Medical devices Type: FAQ

The necessary qualifications of the investigators are checked by the ethics committee when the application is submitted. Further information can be found on the AKEK website.

In which member state must a performance study be approved or notified? Date: 17. August 2022 Topics: Medical devices Type: FAQ

As soon as a part of the performance study (such as recruitment, sample collection or application of the IVD) takes place in Germany, it must be checked whether the study is subject to a notification or authorisation requirement. The provided

Reporting Recalls Date: 17. August 2022 Topics: Medical devices Type: Article

Reporting Recalls

SAE reporting for performance studies Date: 17. August 2022 Topics: Medical devices Type: Article

SAE reporting for performance studies

Which SAE and DD reporting obligations apply from the date of application of the MDR in Germany? Date: 17. August 2022 Topics: Medical devices Type: FAQ

Information on SAE and DD reporting requirements can be found in the Applications and Reports section.

Substantial modifications Date: 17. August 2022 Topics: Medical devices Type: Article

Substantial modifications to a performance study must be notified to the competent ethics committee and the competent federal higher authority in accordance with Article 71 of the European Regulation 2017/746 (IVDR), and Section 54 of the Medical …

Request for authorisation of a performance study Date: 17. August 2022 Topics: Medical devices Type: Article

Performance studies of in vitro diagnostic devices (IVDs) that are not intended solely for research purposes and where the investigational device either may not yet bear a CE mark or its use in the performance study is outside its intended purpose …

Evaluation vnd.openxmlformats-officedocument.wordprocessingml.document, 25KB, File does not meet accessibility standards Date: 17. August 2022 Topics: Medical devices Type: Download

Summary evaluation of serious adverse events (SAEs) and device deficiencies (DDs)
Report template version 4, 2021-06-25

Request for authorisation of a clinical investigation Date: 17. August 2022 Topics: Medical devices Type: Article

Clinical investigations of medical devices that are conducted as part of the clinical evaluation for conformity assessment purposes and where the investigational device either may not yet bear a CE mark or its use in the clinical investigation is …

Annex 3.1 complication rates vnd.openxmlformats-officedocument.spreadsheetml.sheet, 43KB, File does not meet accessibility standards Date: 17. August 2022 Topics: Medical devices Type: Download

SAE and DD complication rates within clinical investigations or performance studies
Table version 4, 2021-06-25

Notes PDF, 485KB, File does not meet accessibility standards Date: 17. August 2022 Topics: Medical devices Type: Download

Notes on completing the summary evaluation of serious adverse events (SAEs) and device deficiencies (DDs)
Version 4, 2021-06-25

Is there a transition period for applications for authorisation of a clinical investigation of medical devices? Date: 17. August 2022 Topics: Medical devices Type: FAQ

In Germany, the legislation provides for a cut-off date for the transition to the new legislation for clinical investigations of medical devices. This means that all applications must be submitted and processed according to the legislation valid …

Substantial modifications Date: 17. August 2022 Topics: Medical devices Type: Article

Substantial modifications to a clinical investigation must be notified to the competent ethics committee and the competent federal higher authority in accordance with Article 75 of the European Regulation 2017/745 (MDR), and Section 54 of the Medical …

Notification of Other Clinical Investigations according to Art. 82 par. 1 MDR in Conjunction with Section 53 MPDG Date: 17. August 2022 Topics: Medical devices Type: Article

Other clinical investigations "are governed by the legal basis laid down in Article 82 of Regulation (EU) 2017/745 (MDR), which is further elaborated at national level by the Medical Device Law Implementation Act

Notification of a Post-Market Clinical Follow-up investigation in accordance with Article 74(1) of Regulation (EU) 2017/745 (MDR) Date: 17. August 2022 Topics: Medical devices Type: Article

According to Article 74(1) MDR, a Post-Market Clinical Follow-up investigation (PMCF investigation) is a clinical investigation conducted after the medical device has been placed on the market for the purpose of further assessment of that device.

Temporary Halt, Early Termination or End of a Clinical Investigation Date: 17. August 2022 Topics: Medical devices Type: Article

If the sponsor has temporarily halted a clinical investigation or has terminated a clinical investigation early, it shall inform the Member State.

Frequently Asked Questions (FAQ) Date: 17. August 2022 Topics: Medical devices Type: Article

Here you will find answers to frequently asked questions about clinical investigations and performance studies.

How is the index to be designed to meet the relevant Essential Safety and Performance Requirements? Date: 17. August 2022 Topics: Medical devices Type: FAQ

We recommend that a tabular list be drawn up, arranged in the rows following the Essential Safety and Performance Requirements set out in Annex I to Regulation (EU) 2017/745 (MDR) or Annex I to Regulation (EU) 2017/746 (IVDR). The list should contain …

Is it possible for a sponsor based in Switzerland or Turkey to submit an application? Date: 17. August 2022 Topics: Medical devices Type: FAQ

No. According to Article 62 (2) and (4) (c) MDR or Article 58 (4) and (5) (c) IVDR, the sponsor, if not established in the Union, must appoint a legal representative in the Union. Neither Switzerland nor Turkey is a member of the EU or a contracting …

Urgent Field Safety Notice for Percutaneous dilator set by Coloplast A/S PDF, 106KB, File does not meet accessibility standards Date: 17. August 2022 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - precision instruments for gastrointestinal and urological endoscopy and hysteroscopy
Reference 19440/22

Urgent Field Safety Notice for Dimension Vista CA 15-3 Flex reagent cartride by Siemens Healthcare Diagnostics Inc. Newark PDF, 334KB, File does not meet accessibility standards Date: 17. August 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 18244/22

Urgent Field Safety Notice for LM150TD by Löwenstein Medical Technology GmbH + Co. KG PDF, 612KB, File does not meet accessibility standards Date: 17. August 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 20875/22

Urgent Field Safety Notice for Obstetric suction cup/Geburtshilfe-Saugnapf by Beijing HangTian KaDi Technology R&D Institute PDF, 659KB, File does not meet accessibility standards Date: 16. August 2022 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - gynaecology
Reference 20470/22

Urgent Field Safety Notice for Technomed - Disposable Subdermal Needle Electrode by Technomed Europe PDF, 272KB, File does not meet accessibility standards Date: 16. August 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 19863/22

Urgent Field Safety Notice for Roadrunner PC and UniGlide Hydrophilic Wire Guide by Cook Incorporated PDF, 806KB, File does not meet accessibility standards Date: 15. August 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 18079/22

Urgent Field Safety Notice for V-MAX² Pushing and braking aid by AAT Alber Antriebstechnik GmbH PDF, 79KB, File does not meet accessibility standards Date: 15. August 2022 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - mobility aids
Reference 20179/22

Urgent Field Safety Notice for Original-Perfusorleitung PE 200 cm by B. Braun Melsungen AG PDF, 537KB, File does not meet accessibility standards Date: 11. August 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 18746/22