New Director General for EUCOMED

John Wilkinson, Director General of the Association of British Healthcare Industries (ABHI) since 2004, has been appointed as the new Director General of EUCOMED, the European medical device industry association. Mr Wilkinson took over in March from Maurice Wagner, who has headed EUCOMED for six years.

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Own Brand Labellers Interpretive Document published by European Commission

The European Commission has published the third 'Interpretive Document' on its website, on the long-debated subject of 'own brand labellers'.

Until now, there have been two distinctly different applications of the requirements of the three medical devices directives with respect to devices that are manufactured entirely by one organization, but marketed by another, under the brand name of the latter. After many debates and legal reviews, the Commission has finally come off the fence and agreed with the countries that require the organization that owns the brand with which the device is labelled to take regulatory responsibility as the 'manufacturer', even though it may not actually design, manufacture, package or label the device.

It comments that the own brand labeller meets the definition of manufacturer as set out in the medical devices directives, referencing specifically the part of the definition that states: "placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party".

The document further comments that: "a brand is a symbolic representation of all the information connected to the product. It serves to create associations and expectations around it, and it is the most reliable visible evidence of who has regulatory responsibility from the time where the products are sold until their end-of-life".

A copy of the interpretive document can be accessed here.  

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Revised MEDDEV for devices utilising tissues susceptible for TSE published

The European Commission has published the final draft of revision 2 of MEDDEV 2.11/1 entitled 'Application of Council Directive 93/42/EEC taking into account Commission Directive 003/32/EC for medical devices utilising tissues or derivatives originating from animals susceptible for TSE'.

The stated aim of the publication is to aid the common application of Commission Directive 2003/32/EC by clarifying some aspects of its interpretation, in particular by addressing the evaluation performed by the Notified Body, the activities of the coordinating Competent Authority and the verification role of the other Competent Authorities.

For access to the draft MEDDEV, click here.

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European Commission publishes first 'Interpretive Documents'

The European Commission has published the first of a series of promised 'Interpretive Documents'. These give guidance on how the requirements of the revised MDD, which becomes effective from 21 March 2010, will be applied to devices which overlap with the Personal Protective Equipment (PPE) and Machinery directives (89/686/EEC & 2006/42/EC).

PPE Directive: Some products could be qualified as personal protective equipment as well as medical devices. These products are thus intended for 'dual use'. For example, gloves with a medical purpose in the patient environment are medical devices, but as they are also designed to provide protection to the user, they also fall into the definition of personal protective equipment. This led to a situation where manufacturers had to chose to use either the basic health and safety requirements of the PPE Directive to ensure that the intended user is protected, or use the essential requirements (ERs) of the MDD to ensure that the medical device is safe and performing as intended.

With the amendment of the MDD introduced by revising directive 2007/47/EC, manufacturers of such 'dual use' products must apply the relevant basic health and safety requirements of the PPE Directive as well as the ERs of the MDD. The interpretive document explains that the amendment specifically uses the term 'relevant', as some requirements of the PPE Directive are not applicable or already covered by the MDD ERs. It continues that the medical device must carry the CE marking under the MDD, so that manufacturers who sell 'dual use' products may now use, under the MDD, one single evaluation of the conformity procedure, allowing an assessment of all risks set out in both regimes.

The PPE interpretive document may be accessed here.

Machinery Directive: A similar situation applies to devices that would also fall within the definition of 'machinery' under the Machinery Directive, if the first version of the Machinery Directive (98/37/EC) didn't exclude the possibility. However, the revised Machinery Directive (2006/42/EC) no longer excludes medical devices, and the devices revising directive (2007/47/EC) adds a requirement for devices to also meet the essential health and safety requirements set out in Annex I of the Machinery Directive, to the extent to which these "are more specific than the essential requirements set out in Annex I of this Directive".

The interpretive document explains that only a single conformity assessment is required under the MDD for medical devices that are also machinery, and also that the risk assessment to be carried out for medical devices that are also machinery is the risk/benefit analysis according to the MDD. It also points out that harmonised standards for medical devices which are also machinery should cover any requirements of Directive 2006/42/EC that are applicable to the devices in their scope, and that such standards may have to be reviewed and amended or revised.

It continues that evaluation by manufacturers requires a case by case examination of every individual hazard listed in Annex I of Directive 2006/42/EC. For the hazards which are relevant for a specific medical device, if the ERs of Directive 2006/42/EC are not provided for in the MDD, or are more specific than the ERs set out in Annex I of the MDD, the ERs of Directive 2006/42/EC will have to be met by the medical device concerned. Assessment of compliance to these requirements will be carried out under the conformity assessment procedures of the MDD.

The Machinery interpretive document may be accessed here.

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Further FDA guidance documents

The US FDA has recently published a new guidance document entitled 'Guidance for Industry and FDA Staff Coronary and Carotid Embolic Protection Devices - Premarket Notification [510(k)] Submissions', available here.

FDA explains that these devices are designed to capture and remove embolic material that may be dislodged during the interventional treatment of carotid arteries or saphenous vein bypass grafts, with the intention of reducing the incidence of adverse cardiac or cerebrovascular events. These devices are covered by regulation 21 CFR 870.1250, product codes NFA and NTE.

FDA recommends that manufacturers who perform clinical and non-clinical evaluations or prepare labeling of coronary and carotid embolic protection devices should use this guidance, which allows abbreviated 510(k) notifications to be submitted if the guidance is followed.

In addition, a guidance document entitled 'Guidance for Industry: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products' has been published, and is accessible here.

The introduction to the document comments that manufacturers of medical devices must validate processes, including sterilization, for a device purporting to be sterile, and that the guidance provides information fof consideration when manufacturers propose using alternative methods to sterility testing to confirm the integrity of a container and closure system throughout the product's shelf life or dating period.

FDA has also revised a guidance published initially only two months ago. The document, entitled 'Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, original BLAs, and BLA Supplements', updates the guidance initially published on 28 December 2007, and gives advice on how FDA staff will in future be encouraged to interact with those submitting information to FDA for review, with a view to preventing unnecessary delays in the completion of the review, thus reducing the overall time to market. A copy of the revised guidance can be accessed here.

Finally, FDA has published revised guidance entitled 'Expedited Review of Premarket Submissions for Devices', superseding the guidance published on 26 November 2003. The document details the criteria to be met should a manufacturer believe that its device should be 'fast-tracked' through the market clearance process because it is intended to treat or diagnose a life-threatening or irreversibly debilitating disease or condition, and it addresses an unmet medical need. A copy of the new guidance can be accessed here.

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