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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