CE-Marking your Orthotic and Prosthetic Devices
By: Yvonne Halpaus
Meeting the new European Medical Device Directives is not a choice, it is a law whose regulations are upheld by all member states of the European Union and the EFTA countries: Austria, Belgium, Denmark, UK, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, The Netherlands, Portugal and Sweden.
The Medical Device Directive (MDD) effective date was June 14, 1993 and the transition period ended June 14, 1998. After June 14, 1998 all medical devices (including Orthotic and Prosthetic) had to meet the Medical Directive requirements, with the exception of In-Vitro-Diagnostic products which is covered by a separate directive.
The intent of the Medical Device Directive is to standardize medical device safety requirements throughout all members of the European Union States and applies to foreign and domestic manufacturers equally.
Compliance
Complying with the Medical Device Directive (MDD) requirements for Orthotic and Prosthetic Devices falls largely under risk category I, which allows the manufacturer to self-certify.
Self-certification means complying with the requirements outlined in the MDD and compiling documentation as to how this was accomplished. This is called a technical file which must be placed in Europe to be available to the Competent Authorities,within a reasonable period of time. ( About 2 working days). Any delivery delays result in a loss of credibility for the file.
At a minimum, the technical file documentation consists of:
- General product description
- Design drawings plus manufacturing methods with explanations
- Standards used to comply or other assessment methods (summarized in the essential requirement matrix)
- Risk analysis report
- Results of design calculations, inspections and tests
- User manuals and product labels in the languages of the European Member States the devices are exported to.
Additional documentation requirements are:
- Post production procedure (post marketing surveillance)
- Incident notification procedures
- Recall procedure
Once the technical file documentation is completed, the manufacturer must declare that it’s products are in compliance with the MDD by issuing a written "declaration of conformity". The devices must next be registered with a Competent Authority by the manufacturer or his European Authorized Representative.
All manufacturers outside the European Union States must designate a European Authorized Representative, whose name and address must be shown on the product, the labels and/or user instructions. A manufacturer has options, they can appoint an independent Authorized Representative, knowledgeable in the MDD requirements and the workings of the Competent Authority, or one of their distributors or agents. However, the distributor in country A may not be too thrilled when the name of distributor in country B appears on all products! PLUS REMEMBER! The technical file containing the aforementioned documentation must be placed with each designated entity.
Custom made or adaptation?
Manufacturers of individualized devices should be aware of the following:
Custom made devices are intended for sole use by a particular patient and produced in accordance with specifications prescribed by a qualified practitioner. A mass produced medical device that only needs adaptation is not a custom made device. Custom made devices do not carry a visible CE mark but remain subject to the Medical Device Directive requirements. The manufacturer must issue a statement of conformity for each device stating the patient’s name, device identification, responsible medical practitioners
Custom made (non-mass produced) medical devices must still meet the MDD requirements, but are exempt from a CE mark being affixed to the actual device. These custom made devices must be reported at regular intervals to the competent authorities.
Adapted devices are assembled and/or processed according to the manufacturer’s instructions by an orthopedic practitioner (in Europe). This device must be CE marked by the manufacturer whose name appears on the product. If the product is processed without manufacturer instructions, or if the practitioner deviates from the manufacturer instructions, the practitioner becomes the manufacturer and must meet the MDD requirements and CE mark the device.
Additional conformity requirements:
Risk Class I devices that are sterile or perform a measuring function must be assessed by an independent assessment institute, called a "Notified Body". The Notified Body will only assess the aspects of the sterility or measurement function.
Devices that fall in Risk Class IIa, IIb or III by definition of the Medical Device Directive must also apply for an assessment by a Notified Body which may include product testing and/or quality system audits.
Enforcement:
European customers and/or patients may no longer use non-CE marked devices since June 14 ‘98. Devices placed in the distribution channel before June 14 ‘98 may continue to be sold for a period of 2 years.
Customs may perform visual checks before clearing the product for entry into any European Union State.
The Competent Authority will perform random or systematic checks of all CE marked devices.
Competitors may report any non-compliant device to the authorities.
Non-compliance:
Non-CE marked or incorrectly labeled products. If a device does not comply with the requirements of the Medical Device Directive, including non-CE marked or incorrectly labeled products, Member States are obliged to take measures against the manufacturer and/or his Authorized Representative. As an extreme measure, limitations can be imposed on the manufacturer or a device can even be prohibited from being sold and used. Member States must inform the European Commission and other Member States when they take this sort of measure.
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