Tag Archives: MDD

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

MDD–Article 8

By Dr. Christopher Joseph Devine
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Dr. Christopher Joseph Devine, President, Devine Guidance International

Article 8, of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD) delineates the requirements for the “Safeguard Clause.” The takeaway from this edition is simple: device manufacturers are expected to react quickly when their devices have been identified as posing a threat to public health and safety within the EU.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

MDD–Articles 6 & 7

By Dr. Christopher Joseph Devine
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Dr. Christopher Joseph Devine, President, Devine Guidance International

This week, we briefly discuss Articles 6 and 7. For this edition, the takeaway is simple, read and understand Articles 6 and 7; however, do not lose sleep worrying over their impact on device manufacturers. Why? Because Articles 6 and 7 pertain to the Commission, the Committee and the establishment of rules for the oversight of standards, period.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

MDD–Article 5

By Dr. Christopher Joseph Devine
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Dr. Christopher Joseph Devine, President, Devine Guidance International

Article 5 of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD) defines the requirement for “reference to standards.” For this week, there is just one takeaway. The notified bodies like the harmonized standards. They will make the lives of device manufacturers miserable if the manufacturers fail to embrace these same standards.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

MDD–Article 4

By Dr. Christopher Joseph Devine
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Dr. Christopher Joseph Devine, President, Devine Guidance International

Article 4 of the Medical Device Directive establishes the requirements for “free movement, devices intended for special purposes.” This week’s Devine Guidance will provide some insight needed for complying with Article 4 of the MDD. In my opinion, the language issue will continue to be a challenge for the device industry, for the foreseeable future.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

MDD–Article 3

By Dr. Christopher Joseph Devine
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Dr. Christopher Joseph Devine, President, Devine Guidance International

There are three takeaways from this week’s edition: one, Article 3 of the MDD establishes the need for compliance to Essential Requirements with a mandate to comply with Annex I; two, completion of the ERC is not optional, it is a requirement, and you are expected to keep the checklist current; and three, Dr. D strongly suggests adhering to harmonized standards.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

MDD – Definitions and Scope

By Dr. Christopher Joseph Devine
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Dr. Christopher Joseph Devine, President, Devine Guidance International

The Medical Device Directive encompasses a far more complex array of documents than the Quality System Regulation. The major takeaways from this edition of DG are: (a) significant changes made to the definitions of the MDD (21 March 10) should be clearly understood; (b) PPE requires a stand-alone and unique ERC; (c) depending on the application, software is now in scope of the MDD; and (d) combination devices require compliance to requirements delineated in multiple Directives.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Identification and Traceability

By Dr. Christopher Joseph Devine
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Dr. Christopher Joseph Devine, President, Devine Guidance International

The identification and traceability (sections 820.60 and 820.65) for products and finished medical devices, throughout the entire manufacturing process, including raw materials employed during the manufacturing process, and the subsequent sale and distribution of medical devices, are critical elements of the Quality System Regulation (QSR).

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Purchasing Controls

By Dr. Christopher Joseph Devine
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Dr. Christopher Joseph Devine, President, Devine Guidance International

Over the past two months, Dr. D has focused on supplier management from a quality and regulatory perspective. However, the successful execution of a well-defined supplier-management system, and the overall organizational success within the medical device industry, is premised on a strong cross-functional approach to quality. It takes a collegium (may need to look it up) of dedicated professionals, in multi-functional roles, to ensure all aspects of the supplier management system function efficiently. In…

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