GMP News - Medical Devices

25.09.17

Remarkably few Warning Letters to Medical Device Manufacturers in the first Half of Fiscal Year 2017

The ECA evaluates deficiencies regarding medical devices in FDA Warning Letters on a regular basis. Remarkable is the low number of Warning Letters to medical devices manufacturers in the first half of fiscal year 2017.

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25.09.17

Current FDA Publications regarding Medical Devices

In irregular intervals, the ECA publishes overviews about new guidelines or guideline drafts, webinars, general strategy papers and about FDA inspection results regarding medical devices. Find out what the FDA issued recently with regard to medical devices.

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28.03.17

Validation vs. Verification of Medical Devices - An Interesting FDA Warning Letter

It its cGMP regulations for medical devices (21 CFR 820 (Quality System Regulations), the FDA also addresses the topic of validation (21 CFR 820.75). In the course of its inspections, the authority reviews the validation of the manufacturing processes. The FDA criticised according deficiencies at a Taiwanese medical devices manufacturer with a Warning Letter.

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28.03.17

MHRA Guideline on Re-Manufacturing of Single-Use Medical Devices

Last year the MHRA published a 11-page guidance about the re-manufacturing of single-use medical devices (SUDs). Alhough only valid for the UK the content of the MHRA Guidance on Single-Use Medical Devices is interesting.

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28.03.17

EMA Concept Paper on Combination Products

Since February, 16th 2017 you can comment on a concept paper of the EMA on the development of a guideline with regard to the quality requirements of "combination products" - called "Drug-Device-Combination" (DCC) in the document.

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12.01.17

FDA publishes Final Guideline on GMP for Combination Products

In the beginning of 2015 the FDA has published a draft guideline about GMP for Combination Products. Now the final version has been published. What are the differences between the draft and the final version of the FDA Guideline for Combination Products?

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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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