Regulations for Medical Devices

Fundamentals of Regulatory Affairs for Drugs and Medical Devices

European regulations

In 1985, Europe has adopted a policy of the New Approach to technical harmonization and standardization to promote the free movement of medical devices. These medical devices are covered by the Guidelines:

  • Directive 93/42/EC (consolidated with amendment 2007/47) concerning medical devices (MD). This directive contains the essential requirements for safety, health, environment and consumer protection.
  • The Directive 90/385/EEC (consolidated with amendment 2007/47) on active implantable medical devices (AIMD). It contains the essential requirements for active implantable medical devices.
  • Directive 98/79/EC on medical devices for in vitro diagnosis (IVDMD).
  • Directive 2000/70/EC amending Directive 93/42/EC as regards medical devices incorporating stable derivatives of human blood or human plasma (invoked as the directive of human blood).
  • Directive 2005/50/EC amending Directive 93/42/EEC on the reclassification of joint replacement of the hip, knee and shoulder

Directive 93/42/EEC concerning medical devices and their accessories, knowing that by medical device means:

  • Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the need for the proper functioning of this software.

These devices are intended by the manufacturer to be used in humans for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, mitigation or compensation for an injury or disability, investigation, replacement or modification of the anatomy or of a physiological process.

Download Directive 93/42/EEC consolidated

Directive 90/385/EEC applies to medical devices "active implantable", ie the dependent devices for operation of a source of electrical energy or any other energy source than that directly generated by the human body or gravity, and which are designed to be totally or partially within the human body.

Download the consolidated Directive 90/385/EEC

The Directive 98/79/EEC applies to medical devices and in vitro diagnostic accessories that meet the following definitions:

Any medical device which is a reagent, reagent product, calibrator material, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination, intended by the manufacturer be used in vitro for the examination of specimens derived from the human body, including the donation of blood or tissue, to provide information:

  • concerning a physiological or pathological condition
  • concerning a congenital disease
  • to determine the safety and compatibility with potential recipients
  • to monitor therapeutic measures

Download Directive 98/79/EEC

General Principles Compliance DM and IVDD

  • Essential requirements: Annex I of the DM identifies 14 essential requirements, plus 54 points at which a manufacturer must meet before the CE marking can be affixed to the product. The essential requirements relate to patient safety, product performance, safety use, transport and storage, the risks and benefits as well as technical requirements and manufacturing.
    Annex I defines the IVDMDs eight essential requirements, each with a number of issues, including the scope closely approximates that of the DM.
  • Class of devices: See Class DM - Class of IVDMDs *
  • Risk Analysis: Risk analysis aims to identify all the hazards associated with a device, assess the risks and minimize by appropriate mitigation actions. Risk analysis is conducted with reference to the ISO 14971 standard.

Parexel Intl Corp Medical Device Development: Regulation and Law
Book (Parexel Intl Corp)
2011-04-18 10:26:37 by NewMsLoree

This is scary... and long...

The Free Speech About Science Act (H.R. 1364), “health freedom,” and misinformed consent
“Health freedom.” It’s a battle cry frequently used by supporters of “alternative” medicine against what they perceive to be persecution by the medical and scientific establishment that uses the Food and Drug Administration, the Federal Trade Commission, and other federal agencies charged with regulating pharmaceuticals, food, cosmetics, and medical devices in order to protect the public against fraud, adulterated food, and quackery. It’s a potent argument to those not versed in skepticism and science-based medicine, and even to many who are

2003-10-21 21:53:47 by dermdoc

Clarification on lasers

I think you are referring to the following statement:
"Several manufacturers received FDA permission to claim, "permanent reduction," NOT "permanent removal" for their lasers. This means that although laser treatments with these devices will permanently reduce the total number of body hairs, they will not result in a permanent removal of all hair. The specific claim granted is "intended to effect stable, long-term, or permanent reduction" through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing after a treatment regime, which may include several sessions

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