GMP News - Medical Devices

We have already reported on the experiences of notified bodies regarding remote audits in the past. Recently, the results of a survey addressed to Notified Bodies on remote audits have been published.

The European Commission published Questions & Answers on 26 May 2021, the day of application of Regulation 2017/745 for medical devices. The Questions & Answers are related to the requirements and tools for the safety of medical devices, including EUDAMED.

The US FDA recently issued a draft guidance to help manufacturers implement ICH Q12 by explaining how to submit ECs. In addition, the agency provides general guidance about the elements that are considered ECs for the device constituent part of combination products.

In a previous News you could read about audit alternatives of Notified Bodies in Covid-19 times. The guideline was based on a document of the Medical Device Coordination Group (MDCG). This guideline has now been supplemented by a question and answer document.

Within the framework of a survey via the EU Commission, Notified Bodies in the medical devices sector were asked about their experiences with "remote audits". The results are now available.

Medical devices are essential medical tools and that is why health authorities are also interested in their development. For this purpose, the FDA has presented a catalog of tools for the development of medical devices.

The ECA regularly provides you with analyses of the deficiencies in FDA Warning Letters regarding medical devices. In the comparable period of the years 2017, 2018 and 2019 (1 October - 30 September), we mentioned the noticeably low number of Warning Letters. This trend is also evident for the first half of the fiscal year 2020 (1 October 2019 - 31 March 2020). Learn more about the top 3.