Tag Archives: Food and Drug Administration

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

MDD–Article 9

By Dr. Christopher Joseph Devine
No Comments
Dr. Christopher Joseph Devine, President, Devine Guidance International

This week, we discuss Article 9 of the Medical Device Directive that delineates the requirements for Classification. In fact it is Dr. D’s opinion that the European approach to device classification is significantly better than the approach pursued by FDA. Remember, device classification will drive the path for conformity for devices entering the EU, and ultimately, the need for compiling a technical file or a design dossier to support the application process.

Continue reading

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

MDD–Article 8

By Dr. Christopher Joseph Devine
No Comments
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.

Continue reading

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

MDD–Articles 6 & 7

By Dr. Christopher Joseph Devine
No Comments
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.

Continue reading

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

MDD–Article 5

By Dr. Christopher Joseph Devine
No Comments
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.

Continue reading

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

MDD–Article 4

By Dr. Christopher Joseph Devine
No Comments
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.

Continue reading

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

MDD–Article 3

By Dr. Christopher Joseph Devine
No Comments
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.

Continue reading

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

MDD – Definitions and Scope

By Dr. Christopher Joseph Devine
No Comments
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.

Continue reading

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

Consent Decree

By Dr. Christopher Joseph Devine
No Comments
Dr. Christopher Joseph Devine, President, Devine Guidance International

Consent decrees are expensive. Remember, consent decree and the resulting actions are driven by the courts and all bets are off in regards to when normal business operations will return, if ever. If the process of paying the third-party consultants does not grab the attention of the controller, rest assured the fines levied by the courts should. One final thought, with no new product approvals from FDA on the horizon, your competitors will be thanking you as your customer base and market share quickly be…

Continue reading