Medical Devices & In-Vitro Diagnostics
The main Directive 93/42/EEC covers the sales and marketing of Medical Devices. This Directive has had several amendments the most recent being Directive 2007/47/EC which came fully into force on 21 March 2010.
In this latest Directive, a "Medical Device" is defined as:
"any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
- investigation, replacement or modification of the anatomy or of a physiological process,
- control of conception,
and which does not achieve its principle intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means."
Examples of Medical Devices are as follows:
- first aid bandages
- tongue depressors
- X-ray equipment
- dental materials
Software can be incorporated in medical devices or exist as standalone software, for example:
- Active Implantable medical devices
- Software that directly controls an apparatus such as radiotherapy treatment
- As an accessory to a medical device
- Software used on mobile devices i.e. mobile apps
*** Important ***
In Europe a much tougher new regulatory framework will be introduced in 2017 requiring some devices to go through a pre-market assessment process by the European Medicines Agency (EMA). Key changes are:
- Two Regulations to replace the existing three directives
- Reinforced rules for clinical investigations/evaluations
- Unannounced visits by Notified Bodies
- Reinforced rules for clinical investigations and clinical evaluations (new concept in IVD legislation)
- 80% of IVDs will require conformity assessment by a Notified Body whereas currently only 20% require this under the existing EU Directive.
The U.S. Food and Drug Administration (FDA) regulates medical devices to assure their safety and effectiveness and develops and carries out a national program designed to control unnecessary exposures to, and assure safe and efficacious use of, ionizing and non-ionizing radiation-emitting electronic products. The Center for Devices and Radiological Health (CDRH) is the component within the FDA that is responsible for this program. The FDA's legal authority to regulate both medical devices and electronic radiation-emitting products is the Federal Food Drug & Cosmetic (FD&C) Act.
The FD&C Act contains provisions i.e. regulatory requirements, that define FDA's level of control over these products. To fulfil the provisions of the FD&C Act that apply to medical devices and radiation-emitting products, the FDA develops, publishes and implements regulations. These regulations are initially published in the Federal Register (FR) for public comment. The FR is a compilation of the daily government activities including proposed and final regulations.
Final regulations are subsequently placed or codified into the Code of Federal Regulations (CFR) on an annual basis. Most of FDA's medical device and radiation-emitting product regulations are in Title 21 CFR Parts 800-1299. These final regulations codified in the CFR cover various aspects of design, clinical evaluation, manufacturing, packaging, labelling and post market surveillance of medical devices. In addition, the regulations address standards and product reports that apply to radiation-emitting products. The main part being the following CFRs.
- Establishment Registration - 21 CFR Part 807
- Medical Device Listing - 21CFR Part 807
- Premarket Notification 510(k) - 21 CFR Part 807 Subpart E
- Investigational Device Exemption (IDE) - 21CFR Part 81
- Quality System Regulation (QS)/Good Manufacturing Practices (GMP) - 21 CFR Part 820
- Labeling - 21 CFR Part 801
- Medical Device Reporting - 21 CFR Part 803
One of the most important aspects of getting a medical device or radiation-emitting product to market is to know where to begin. The requirements for marketing a radiation emitting non-medical device differ from those radiation-emitting products that are also medical devices. For example, a non-medical laser would require an initial report, whereas a laser for use in ophthalmic surgery would require both an initial report and the filing of a 510(k) premarket notification to obtain clearance prior to marketing.
The starting point is determining whether the product you plan to market is a medical device, as defined in section 201(h), or a radiation-emitting product, as defined in section 531 of the FD&C Act, or both. If your product meets either of these definitions, it will be subject to the provisions of the FD&C Act i.e. there are FDA regulatory requirements that must be met before a product can be marketed in the U.S. The purpose of Device Advice is to help you decide whether your product is subject to FDA regulations, and if so, to identify what these regulatory requirements are and help you comply with them.
Please contact us with your specific regulatory compliance requirements. We look forward to working with you.