What is a combination product?

A combination product is a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. Under 21 CFR 3.2 (e), a combination product is defined to include:

1. A product comprised of two or more regulated components (i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic) that are physically, chemically, or otherwise combined or mixed and produced as a single entity;

2. Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products;

3. A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where, upon approval of the proposed product, the labeling of the approved product would need to be changed (e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose); or

4. Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect.

Who is required to file mandatory reports of device-related adverse events?

The Medical Device Reporting (MDR) regulation is found in Title 21 of the Code of Federal Regulations, Part 803. This regulation specifies the reporting obligations of medical device manufacturers, importers, distributors, and user facilities. FDA has defined a device user facility as a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility. A user facility subject to MDR may be either an independent entity or operated by another medical entity. Vigilance reporting and monitoring requirements vary by country.

What is considered a serious injury under the MDR regulation?

Serious injury means an injury or illness that:

is life-threatening; or

results in permanent impairment of a body function or permanent damage to a body structure; or requires medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure.

An example of a serious injury is a patient who experiences persistent visual symptoms after a LASIK procedure such that the eye care provider reasonably concludes that the patient has suffered permanent visual impairment or permanent eye damage attributed to use of the laser during the LASIK procedure. FDA expects that user facilities will exercise due diligence and professional judgment in determining whether a serious injury has occurred. Further, FDA expects that a user facility will have written procedures for making this determination and for documenting such determinations.

Are the rules for placing a medical device on the market identical in all European countries?

Yes. The new approach Directives 90/385/EEC, 93/42/EEC and 98/79/EC aim to provide a common legislative base for all European countries (EU and EFTA).

However, we recommend that you consult the national law in which the Directives are adapted (the Public Health Code in the case of France).

What are the Directives?

The Directives that are most relevant to medical device manufacturers are the Medical Devices 93/42/EEC and Medical Devices in Vitro Diagnostics 98/79/EC. Products can be covered by more than one Directive. Whether one or more Directive applies, manufacturers must ensure that their product meets the requirements set out in the Directive(s), together with the standards issued under the authority of the Directive.
A full list of the Directives and copies can be downloaded from: http://www.newapproach.org

Who Needs to Comply with the Medical Devices Directive?

The Medical Devices Directive applies to anything which is principally intended for one of the following purposes: diagnosis, prevention, monitoring, treatment or alleviation of disease, injury or replacement or modification of the anatomy. etc. It specifically excludes active implantable devices and in-vitro diagnostic devices which are covered by their own directives, but it includes any electronic apparatus such as personal computers (and their software) which are principally used for medical purposes.

What countries require the CE mark?

The affixing of the CE Mark is required on designated products exported to the following countries: