GMP News - Medical 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.

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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?

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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.

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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.

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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.

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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.

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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?

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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.

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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.

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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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19.05.20

FDA Feedback after an Inspection at a Medical Device Manufacturer - Update 2020

An FDA draft guideline describes (non-binding) feedback after an FDA inspection of a Medical Device manufacturer. This guideline has now been finalized and was released in April 2020. What changes have been made?

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18.02.20

Information on the Medical Devices Regulation

The application of the Medical Devices Regulation (2017/745, MDR) as of 26 May 2020 is approaching. Find out more about the MDR environment.

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18.02.20

How to authorize a Combination Product in the USA?

In the USA, combination products are regulated independantly.  A draft document from the FDA entitled "Principles of Premarket Pathways for Combination Products" describes the ways in which marketing authorisations are granted in the USA and how the various Centers interact.

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18.02.20

When does the FDA announce the Inspection of a Medical Device Manufacturer?

With the entry into force of the FDA Reauthorization Act (FDARA) in August 2017, sections on the inspection of medical device manufacturers in the USA and abroad also became effective. A draft document from the FDA on inspections of medical device manufacturers has been issued for some time now to further harmonize and interpret the changes.

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18.02.20

Guide on the Use of Type V Drug Master Files for Combination Products

In October 2019, the FDA issued guidelines in a draft document regarding the use of a Type V Drug Master File (DMF). In this document, information can be made available to the CDER (if it is in charge of the (project) approval procedure) concerning the medical device proportion of a combination product.

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