GMP News - Medical Devices

10.01.17

IMDRF publishes Guidance Draft on Clinical Studies with Software as a Medical Device

The IMDRF (International Medical Devices Regulator Forum) is the successor organisation of the Global Harmonisation Task Force (GHTF). Recently, the IMDRF has published a guidance draft entitled "Software as a medical Device (SAMD): Clinical Evaulation".

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10.01.17

FDA's Plans with regard to Medical Devices in 2017

What the FDA plans with regard to the regulation of medical devices can be found in a report on Regulatory Science Priorities.

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10.01.17

FDA's Current Publications for Manufacturers of Medical Devices

In irregular intervals, the ECA publishes overviews over new guidances or draft guidances, webinars, general strategy papers and inspection outcomes of the FDA with regard to medical devices. Find out more in the selection of FDA publications of the last months.

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29.09.16

New MEDDEV Document on the Clinical Evaluation of Medical Devices

To put the EU Medical Devices (93/42/EEC and 90/385/EEC) in concrete terms, the EU issues so-called MEDDEV documents. In this context, the document MEDDEV 2.7/1 revision 4 entitled "Clinical Evaluation: A Guide for Manufacturers and Notified Bodies under Directives 93/42/EEC and 90/385/EEC" has been newly published. Comprising 65 pages, the document is very extensive and describes requirements for the clinical evaluations of medical devices in Europe.  

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29.09.16

WHO publishes Second Draft of a Global Medical Devices Regulation

With a draft document made up of 66 pages, the WHO intends to provide support regarding the introduction and implementation of regulations with regard to medical devices, including in vitro diagnostic medical devices (IVDs). The document is a revised draft whose first version - however - hasn't been published. The document history shows that the revision had become necessary as the first draft was too complicated. What does the second draft contain?

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29.09.16

MHRA publishes Draft Guidance on "Usability" of Medical Devices

With its new draft guidance on human factors and usability requirements, the MHRA is giving greater emphasis to design process in the development of medical devices and combination products - particularly with regard to the increasing complexity of these products. Find out more about the MHRA's expectation for medical devices and combination products in terms of design process.

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30.06.16

Which Deficiencies in the Quality System of Medical Devices Manufacturers were found by the FDA in 2015?

The ECA regularly publishes statistics of Warning Letters issued by the FDA to medical devices manufacturers. For some time, the FDA has also been publishing statistics regarding deficiencies with regard to the Quality System of medical devices manufacturers. What were FDA's findings in 2015?

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09.06.16

EU agrees on new Rules for Medical Devices

In the aftermath of the PIP scandal (4957), the EU has been planning for a long time a tightening of the rules for medical devices. In future, two regulations for medical devices and in-vitro diagnostics (IVDs) will be created on the basis of the 3 existing guidelines for medical devices (plus a supplement). How does the agreement of the EU look like?

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09.06.16

FDA: Current Publications for Medical Devices Manufacturers

From time to time, the ECA publishes overviews of new guidances or draft guidances, webinars, general strategy papers and inspection outcomes of the FDA with regard to medical devices. Please read more about the FDA publications of the last months.

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09.06.16

MHRA publishes Guideline on Borderlines with Medical Devices

When is a medical device considered a medical device and when isn't it? The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) tries to answer this question in a 12-page guideline. Here you can find a summary of the MHRA guideline "Borderlines with medical devices".

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25.02.16

FDA Status Report Medical Devices Single Audit Programme

A programme led by the FDA is currently running in the area of medical devices: the Medical Devices Single Audit Programme (MDSAP). Read more about an interim report of the FDA presenting the current status and the further steps.

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25.02.16

Medical Devices Warning Letter Statistics 2015 - Process Validation again in the Top 5

In a recent news we reported about statistics of the FDA from the first half year 2015 with regard to Warning Letters addressed to medical devices manufacturers. Please read more about the current evolution of the top 5 list regarding medical devices for the complete fiscal year 2015 (1 October 2014 to 30 September 2015, as of 10 October 2015).

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21.01.16

FDA publishes List of Planned Guidances on Medical Devices for 2016

At the end of 2015, the Center for Devices and Radiological Health (CDRH) published a list containing the guidelines planned for fiscal year 2016 (1st October 2015 - 30 September 2016) as well as older guidelines which might be updated. Learn more about the planned FDA Guidances.

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21.01.16

FDA's Current Publications for Manufacturers of Medical Devices

In irregular intervals, the ECA publishes overviews of new guidances or draft guidances, webinars, general strategy papers and inspection outcomes of the FDA with regard to medical devices. Find out more about the current publications of the FDA.

more

21.01.16

Quality Metrics - Required for Medical Devices too?

Recently, the FDA has published a draft guideline on the determination of Quality Metrics. With regard to medical devices, the FDA is now pursuing a similar path. Under the heading "Case for Quality" (CfQ), the FDA would like to improve the quality of medical devices.

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