Tag Archives: Council Directive 93/42/EEC

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

MDD – Annex II

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

This week, we discuss Annex II (EC Declaration of Conformity – full quality assurance system) of the Medical Device Directive, which delineates the regulatory requirements necessary for compliance with the Directive employing an acceptable quality assurance system. Annex II is really a straightforward document with requirements relatively easy to comprehend. There are three major components: (a) application and approval of a QMS by a notified body; (b) application and approval of the actual device applic…

Continue reading →

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

MDD – Annex I

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

Device manufacturers already shipping into the European Union understand the ramifications of having product that fails to meet essential requirements or a quality system failing to meet the requirements detailed within the annexes associated with the Medical Device Directive. It is the opinion of Dr. D, that the Annexes associated with the MDD is where the proverbial rubber hits the road. This week, we cover Annex I of the MDD.

Continue reading →

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

MDD – Articles 22 and 23

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

This edition of Devine Guidance provides guidance for the final two Articles associated with the Medical Device Directive. Article 22 mandates that Member States are required to comply with the MDD no later than 01 July 1994, and Article 23, while not addressed to device manufacturers, is addressed to Member States. Device manufacturers need to know that there are 23 Articles; however, in regards to Articles 22 and 23, they have zero influence on device manufacturers so please, just “forgetta-bout-it.”

Continue reading →

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

MDD – Article 21

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

Article 21 of the Medical Device Directive delineates the requirements for “Repeal and Amendment of Directives.” It is incumbent upon device manufacturers to ensure all of these changes have been captured and adequately addressed within your organizations. If your organization has not implemented these changes, Dr. D suggests you “Get er done.”

Continue reading →

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

MDD – Article 20a

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

Article 20a of the Medical Device Directive delineates the requirements for “Cooperation.” While the term almost sounds like an oxymoron, much like “military intelligence” or “genuine artificial jumbo shrimp,” there is just one takeaway for this edition of DG: this directive requires the Competent Authorities, from each of the Member States, to cooperate – period!

Continue reading →

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

MDD – Article 20

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

Article 20 of the Medical Device Directive delineates the requirements for “Confidentiality.” There are three takeaways from this edition: Under the Directive, reasonable attempts at confidentiality are required to be sustained; three categories of information are not protected under the confidentiality clause—registration, user, and certification information; and the best way an organization can protect itself in regards to the managing of proprietary information is through a well-documented policy augm…

Continue reading →

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

MDD – Article 19

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

Article 19 of the Medical Device Directive delineates the requirements for “Decision in Respect of Refusal or Restriction.” There are two takeaways: One, Member States must provide rationale in regards to decisions made that result in market withdrawals, refusals, and restrictions; and two, device manufacturers and/or their authorized rep shall have the opportunity to consult with the Member State in regards to the decisions made.

Continue reading →

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

MDD – Article 18

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

This week’s edition of Devine Guidance is all about the (CE) mark, the whole mark, and nothing but the mark. There’s just one takeaway: Never affix a CE Mark on device packaging until written approval and certification is received from the device manufacturer’s notified body.

Continue reading →

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

MDD – Article 17

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

This week discusses the requirements for “CE Marking.” Devices entering into commerce within the EU, unless identified as custom-made or for a clinical investigation, require a CE Marking that indicates conformity to its essential requirements; the device manufacturer cannot affix the CE Marking until certification is issued by their notified body; the CE Marking must be visible and legible; and it cannot be altered, changed, improved upon, hidden, obstructed, defaced, or augmented in a manner that would…

Continue reading →