GMP News - Medical Devices

26.01.21

Combination Products in the USA

Combination products in the US are separately regulated by the FDA via GMP regulations. A dedicated FDA website provides guidance on combination products.

26.01.21

Survey Results on "Remote Audits" of Notified Bodies

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.

08.10.20

Audit Alternatives of Notified Bodies in Covid-19 Times

Due to the Covid-19 pandemic, on-site audits by Notified Bodies are partly only possible to a limited extent or not at all. What are the alternatives? A guideline of the Medical Device Coordination Group (MDCG) provides information on this.

08.10.20

FDA Publishes Catalog of Tools for the Development of New Medical Devices

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.

08.10.20

Reprocessing of Medical Devices - Implementing Regulation for Single-Use Devices

The reprocessing of single-use devices in the medical device sector is left to the EU Member States. However, only the national law of the respective member states must allow this. Now, an implementing regulation is available which describes common specifications for reprocessing single-use devices.

16.09.20

Medical Device Warning Letter Statistics for the first Half of the Fiscal Year 2020

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.

16.09.20

FDA Feedback on Combination Products

There is a draft guideline on combination products describing the ways in which a sponsor can communicate with the FDA during the development of a combination product. What does it say?

16.09.20

Marketing of Medical Devices in the UK after the Transitional Period

The UK Medicines and Healthcare Products Regulatory Agency MHRA has published a guide the marketing of medical devices after the transitional period in the UK.

29.07.20

ISO TR 20416 on Post-Market Surveillance published

The new ISO Technical Report on Post-Market Surveillance for medical devices has been published this month. It shall help to implement a Post-Market Surveillance Process according to (EU) MDR 2017 / 745.

23.07.20

ISO TR 24971 Guidance on Risk Management published

The new ISO TR ISO/TR 24971:2020 Guidance on Risk Management for medical devices has been published last month. This Technical Report provides additional guidance on how to implement a Risk Management System according to ISO 14971.

07.07.20

Extractable Elements in Plastic Materials - Extended Deadline for Comments

The drafts for the new Ph. Eur. chapters on plastic packaging materials (COP, COC, and Extractable elements in plastic materials for pharmaceutical use) have been re-published in Pharmeuropa to give stakeholders sufficient time to comment.

07.07.20

Survey results on the Postponement of the Medical Devices Regulation

Due to the Covid-19 pandemic, the EU had decided to postpone the date of application of the Medical Devices Regulation by one year to 26 May 2021. What consequences does this have for the industry?

07.07.20

New FDA Guide on Inspections of Medical Device Manufacturers

A FDA draft guideline entitled "Review and Update of Device Establishment Inspection Process and Standards" on FDA inspections of medical device manufacturers has now been finalized.

19.05.20

Postponement of the Medical Devices Regulation - Notified Body Team Statement

With its new Regulation 2020/561, the EU has postponed the beginning of application of the Medical Devices Regulation 2017/745 for one year to May 26, 2021. The Regulation will only be effective after this date. The European Association of Notified Bodies in the Medical Devices sector (Team NB) has now issued a statement on the new regulation.

19.05.20

IMDRF publishes Guidance Document on Medical Device Cybersecurity

The International Medical Device Regulators Forum (IMDRF) is the succeeding organisation of the Global Harmonisation Task Force (GHTF) in the field of medical devices. The aim of the group is to issue harmonised guidelines. The latest is a guidance document on "Principles and Practices for Medical Device Cybersecurity" from March 2020.

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GMP News - Medical Devices

Combination Products in the USA

Survey Results on "Remote Audits" of Notified Bodies

Audit Alternatives of Notified Bodies in Covid-19 Times

FDA Publishes Catalog of Tools for the Development of New Medical Devices

Reprocessing of Medical Devices - Implementing Regulation for Single-Use Devices

Medical Device Warning Letter Statistics for the first Half of the Fiscal Year 2020

FDA Feedback on Combination Products

Marketing of Medical Devices in the UK after the Transitional Period

ISO TR 20416 on Post-Market Surveillance published

ISO TR 24971 Guidance on Risk Management published

Extractable Elements in Plastic Materials - Extended Deadline for Comments

Survey results on the Postponement of the Medical Devices Regulation

New FDA Guide on Inspections of Medical Device Manufacturers

Postponement of the Medical Devices Regulation - Notified Body Team Statement

IMDRF publishes Guidance Document on Medical Device Cybersecurity

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