Conference Calendar

March 14-18 - American Association of Orthopaedic Medicine Annual Meeting 2017

March 14-December 31 - Canaccord Genuity Musculoskeletal Conference

Complete Calendar »

Earnings Calendar

No Upcoming Events Scheduled
Complete Calendar »

Read our research via:
email art

Weekly Email

rss art

RSS



app icon

iPhone

app store icon

Kindle



Orthopedic and Dental Industry News Complete Archive »

Changes to European Device Safety Regulations; Reprocessing, Biologics to be Addressed in Future Legislation BY ARMELLE WIART, JUNE 5, 2007

The European Parliament recently approved 141 amendments to the Medical Device Directive, the legal framework created in 1990 to regulate device safety throughout Europe. The approval follows a public comment period on the first draft of the Directive, which was introduced in December 2005.

The aim of the amendments package is to fill regulatory gaps that emerged with significant technological advances as well as bring increased transparency to the public in relation to device approval. Notable among the approved amendments were stricter labeling requirements and pressure on devicemakers to avoid using high-risk substances.

The draft resolution also strives to clearly define terms. It states that "only those products will be classified as medical devices which do not contain any viable tissue and cells . . . liable to act upon the body with action that is ancillary to that of the device."

The proposed directive also narrows the type of software that can be considered a medical device as only that which is "specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device."

Several contentious issues that had threatened to derail the original 2005 revision of the Directive have been assigned to a commission for future legislative consideration. These include the definition and uniform labeling of single-use devices as well as the issue surrounding their reprocessing, the adaptation of classification rules, the determination of information on the safe use of devices and the provision of an "urgency procedure" to recall unsafe devices.

Another topic excluded from the current Directive is Biologics. The mention of cell and tissue-based medical devices will be dealt with in future legislature.

Update: On May 31st, the European Union Health Council accepted the amendments package approved by the European Parliament and reiterated the need to urgently address the issue of reprocessing single-use devices.

Email this to a colleague: