What is an accessory to a medical device?
An article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device.
What is a CE Mark?
The CE mark that appears on a medical device or on its packaging means that the device satisfies the relevant essential requirements and is fit for its intended purpose as specified by the manufacturer. All medical devices, (except custom-made devices and those intended for clinical investigations) must bear a CE mark.
What is a class I medical device manufacturer?
Any person who manufactures, for the purpose of placing on the market, a medical device that is classified as a class I device according to the medical devices directive. Class I devices are deemed to carry the lowest risk and so class I manufacturers self-declare conformity with the medical devices directive.
What is conformity assessment for medical devices?
Conformity assessment is the process of demonstrating a medical devices compliance with the Requirements of the relevant Directive. How conformity is demonstrated varies according to the class of the device. All devices except class I medical devices (non-sterile/no measuring function) must undergo conformity assessment by a notified body for medical devices.
What is a Conformity Assessment Body for medical devices?
Conformity assessments for medical devices are conducted, when required, by conformity assessment bodies that have been specifically notified to the Commission i.e. notified bodies. Notified bodies are designated by a designating authority to carry out conformity assessments to the Medical Device, AIMD or IVD directives.
The activities carried out by notified bodies include reviewing technical files and design dossiers for devices, auditing manufacturing facilities and products, assessing changes, issuing, suspending or withdrawing certificates, and conducting manufacturer/product reviews/audits on an ongoing basis.
Medical device manufacturers can chose any notified body to conduct a conformity assessment of a medical device provided that the device is within the scope of designation.
What is a custom-made medical device manufacturer?
A person who specifically makes any device in accordance with a duly qualifiedPractitioner’s written prescription which gives, under their responsibility, specific design characteristics and is intended for sole use of a particular patient.
The prescription for a custom made device must be completed by a person authorized by virtue of their professional qualifications to do so.
Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user are not considered to be custom-made devices.
What are devices for self-testing?
This term generally is applied to in-vitro diagnostic devices which are intended by the manufacturer to be able to be used by lay persons in a home environment
What is an importer of a medical device?
An importer (a person responsible for placing on the market) is any natural or legal person established in the Community who places a product from a third country on the Community market.
What does the term 'intended purpose' mean in relation to a medical device?
The use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional materials
What is a Notified Body?
Notified Bodies are part of the regulatory system established by the Medical Device Directives. They are usually certification bodies with relevant expertise that are responsible for ensuring that the conformity assessment procedures are followed by the manufacturer as well as establishing that devices conform to the relevant essential requirements of the Directives and also to established standards in design and production. Such bodies may be privately or state owned and must be notified formally to the European Commission for the purposes of the Directives by their relevant CA once they have demonstrated that they have met the criteria set out in the annexes to the Directives. They issue the approval to the CE marking of conforming medical devices and they may be notified for some or all of the conformity assessment procedures described in the annexes.
What information should appear on the label of a medical device?
All medical devices must be labelled in accordance with the requirements of the legislation and related standards, e.g. ISO- 15223-1-2007: medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements.
What determines the class of a device?
General medical devices and active implantable medical devices are classified so that the level of regulatory control is proportionate to the degree of risk associated with the device.
The classification rules applied by manufacturers are listed in the Medical Devices Directives and are based on several factors. These factors include the intended use of the product as assigned by the manufacturer, its mode of action, the duration of contact with the patient, the degree of invasiveness, the anatomy affected by the device, whether it is active and the claims made about the product. The manufacturer must be able to substantiate all claims made about the product.
In-vitro diagnostic devices are grouped using a positive listing system into general IVDs, devices for self-testing, Annex II List A or List B..
What is meant by Declaration of Conformity?
5-Declarations of Conformity:
The declaration must be drawn up by either:
The manufacturer (wherever located in the world); or
The manufacturer's authorized representative in the European Community.
The meaning of "manufacturer" and "authorized representative" is not specifically defined but the generally understood meanings apply. In addition, anybody who brands products for supply under their own name (whether or not they actually made them) or who modifies products with or without re-branding may become the "manufacturer" for the purposes of the directive. Where products are not manufactured or placed on the market, then the person who puts the product into service will usually be considered the manufacturer. Exceptionally, where none of these parties has taken responsibility, the importer or supplier may be considered the manufacturer for the purposes of enforcing the directive.
An authorized representative in the Community must be designated by the manufacturer and must therefore be able to demonstrate some legal / commercial arrangement with the manufacturer. The authorized representative may be an individual or a company. A manufacturer outside the Community is not obliged to appoint an authorized representative. A distributor or other commercial representative does not automatically become the authorized representative. In all cases, the person signing the declaration must be in a position to know on behalf of the manufacturer that the product complies with the requirements of the directive based on the design, manufacture, testing and production control of the products concerned. The responsibility is that of the manufacturer (or authorized representative) not of the person signing. The signatory must therefore be in a position to bind the manufacturer or the authorized representative in legal obligations.
What is the minimum content?
There is no minimum content, or indeed, any particular content for a declaration set out However, it is clear that in order to fulfill its purpose it must include at least:
a description of the product or products to which it relates which is clear enough to identify the product available in the market
a declaration that the requirements of Directive 1999/5/EC are complied with
identification of the manufacturer or authorized representative
the name and signature of the person accepting responsibility on behalf of the manufacturer or authorized representative; and
effective date / date of signature.
What about additional recommended content?
The authorities will usually expect to see more than the minimum content above.Typically, in addition to the above, this is likely to include:
a list of any standards used in establishing compliance with the requirements– particularly if they are
European harmonized standards for the purposes of that directive;
where harmonized standards are not used, the reference of the technical construction file that was used to establish compliance;
identification of any notified body involved and a reference to the opinion given by them; and
a statement that the declaration is issued under the sole responsibility of the manufacturer or authorized representative.