BfArM - Federal Institute for Drugs and Medical Devices

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14,950 results

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Urgent Field Safety Notice for Carescape Central Station by GE Medical Systems Information Technologies, Inc. PDF, 949KB, File does not meet accessibility standards Date: 29. August 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 09073/22

Urgent Field Safety Notice for GELITA ENT X-PAND / GELITA-SPON RAPID by GELITA MEDICAL GmbH PDF, 968KB, File does not meet accessibility standards Date: 26. August 2022 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - ointments and gels
Reference 20408/22

Urgent Field Safety Notice for HeartWare Ventricular Assist System by Heartware, Inc. PDF, 549KB, File does not meet accessibility standards Date: 26. August 2022 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - artificial hearts
Reference 04316/21

Urgent Field Safety Notice for Diverse Products with Select Lot Numbers Ending in "R" by Hobbs Medical, Inc. PDF, 2MB, File does not meet accessibility standards Date: 26. August 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 20953/22

Urgent Field Safety Notice for Cobalt XT, Cobalt and Crome ICDs and CRT-Ds by Medtronic Inc PDF, 863KB, File does not meet accessibility standards Date: 25. August 2022 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - defibrillators
Reference 15321/22

Urgent Field Safety Notice for Intra-Aortic Balloon Catheters by Datascope Corporation PDF, 742KB, File does not meet accessibility standards Date: 25. August 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 20313/22

Urgent Field Safety Notice for CorVocet Biopsy System by Merit Medical Systems Inc. PDF, 132KB, File does not meet accessibility standards Date: 23. August 2022 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - gynaecology
Reference 20770/22

Urgent Field Safety Notice for Hamilton-C6 by Hamilton Medical AG PDF, 1,005KB, File does not meet accessibility standards Date: 23. August 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 21484/22

Urgent Field Safety Notice for Connector Box of Imaging Module IM 910 by Haag-Streit AG PDF, 159KB, File does not meet accessibility standards Date: 23. August 2022 Topics: Medical devices Type: Customer information

Product group ophthalmological technology - equipment for ophthalmological diagnostics
Reference 20196/22

Urgent Field Safety Notice for Flocare Infinity Enterale Ernährungspumpe by Nutricia Medical Devices B.V. (formal) PDF, 582KB, File does not meet accessibility standards Date: 22. August 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 20097/22

Urgent Field Safety Notice for APL 2002 Infusionspumpenbesteck by pfm medical mepro gmbh PDF, 973KB, File does not meet accessibility standards Date: 19. August 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 18867/22

Urgent Field Safety Notice for Silicone Resuscitator Set; for infant by VBM Medizintechnik GmbH PDF, 324KB, File does not meet accessibility standards Date: 19. August 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 20858/22

Urgent Field Safety Notice for Secutray by SENGEWALD Klinikprodukte GmbH PDF, 1MB, File does not meet accessibility standards Date: 18. August 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion kits
Reference 14192/22

Urgent Field Safety Notice for Carescape Central Station by GE Medical Systems Information Technologies, Inc. PDF, 179KB, File does not meet accessibility standards Date: 18. August 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 19599/22

How should a final report be structured? Date: 17. August 2022 Topics: Medical devices Type: FAQ

It is recommended that the content of the final report be based on Annex D of the standard DIN EN ISO 14155:2020. For performance studies of in vitro diagnostic medical devices, the final report may also be prepared according to Annex D of ISO

Which legal reporting obligations apply in the event of completion or early termination of the clinical investigation? Date: 17. August 2022 Topics: Medical devices Type: FAQ

For clinical investigations initiated before 26.05.2021 and for performance studies initiated before 26.05.2022, the provisions of Section 23a MPG apply. Within 90 days after termination of a clinical investigation, the sponsor must notify the …

Does it constitute a substantial amendment if investigators or clinical investigation sites change? Date: 17. August 2022 Topics: Medical devices Type: FAQ

Yes, since substantial amendments include all amendments that affect the other requirements assessed by the Ethics Committee.

For a substantial modification, an application for assessment must be submitted to the competent higher federal authority …

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

If the sponsor has temporarily halted a performance study or has terminated a performance study early, it shall inform the Member States.

I have received a notice from the BfArM on the "Determination of Substantiality". What does that mean and what do I need to do next? Date: 17. August 2022 Topics: Medical devices Type: FAQ

Please note that since 26.05.2021 this only applies to subsequent changes in performance studies of in vitro diagnostics.

In the case of notified "other changes", the competent higher federal authority (here: BfArM) may determine that the notified …

How are applications for approval of a clinical investigation (MDR) or performance study (IVDR) submitted? Date: 17. August 2022 Topics: Medical devices Type: FAQ

Clinical investigation:
The authorisation required under Article 62 (4) a) MDR must be applied for by the sponsor to the competent higher federal authority, here: BfArM. In accordance with Article 70 (1) MDR, the application must be submitted by way …

When is a clinical investigation considered to have begun? Date: 17. August 2022 Topics: Medical devices Type: FAQ

A clinical investigation according to MDR is considered to have started ("initiated") as soon as the required approval of the higher federal authority and the consenting assessment of the ethics committee have been obtained.

A performance study …

Are clinical investigations / performance studies with CE-certified medical devices or in-vitro diagnostics subject to approval? Date: 17. August 2022 Topics: Medical devices Type: FAQ

These are not clinical trials or performance studies requiring approval according to the MDR or the IVDR if the medical device is used exclusively within the scope of its intended purpose (strictly according to the instructions for use, incl.

Notification of a Post-Marketing Performance Study in accordance with Article 70(1) of Regulation (EU) 2017/746 (IVDR) Date: 17. August 2022 Topics: Medical devices Type: Article

Performance studies of IVDs with CE marking, within the scope of their intended purpose and additional invasive or burdensome procedures must be notified to the competent authority.

Notifications of performance studies involving companion diagnostics using only left-over samples Date: 17. August 2022 Topics: Medical devices Type: Article

Performance studies involving companion diagnostics using only left-over samples must be notified to the competent authority.

When is it an additional invasive procedure or other risks to subjects? Date: 17. August 2022 Topics: Medical devices Type: FAQ

If there is uncertainty as to whether the procedure is an additional invasive procedure or whether there are other risks to the trial subjects, the ethics committee can provide advice.
Further information from AKEK

Alternatively, a decision can be …

When are performance studies subject to approval or notification? Date: 17. August 2022 Topics: Medical devices Type: FAQ

The provided decision tree serves as a guide as to which performance studies are subject to approval or notification. The information from Chapter VI of the IVDR and Chapter 4 of the MPDG is decisive.

If there is a need for clarification, the BfArM

Which performance studies (previously performance evaluation studies) may be continued under the MPG? Date: 17. August 2022 Topics: Medical devices Type: FAQ

In the European Regulation 2017/746 (IVDR), there is no guidance on performance studies for the transition from the In Vitro Diagnostics Directive (IVDD, 98/79/EC) to the IVDR. However, the German Medical Devices Implementation Act (“

How is a (surgically) invasive procedure defined? Date: 17. August 2022 Topics: Medical devices Type: FAQ

The IVDR does not define the terms. The MDR defines an invasive device as a device that enters the body, in whole or in part, through the surface of the body or through a body orifice (Article 2, 6 MDR). A surgically invasive device is an invasive …

How are residual samples defined? Date: 17. August 2022 Topics: Medical devices Type: FAQ

The MPDG defines the term "residual sample" as residual material of human body substances that originates from a medically indicated collection (§ 3, MPDG).

Which procedures are to be considered additionally burdensome (in the context of PMPF studies)? Date: 17. August 2022 Topics: Medical devices Type: FAQ

This question cannot be answered in a blanket manner, but depends on the individual conditions in each case. Information on this can be found on the website of the working group of ethics committees that advise on this question.