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| CE Marking of Medical Devices |
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| CE Marking of Medical Devices |
BACKGROUND
The Medical Devices Directive 93/42/EEC of 14 June 1993 applies to devices used in medicine and their accessories, including related software. The definition of a medical device includes:
- Diagnostic and monitoring equipment for alleviation of disease, handicap or injury
- Equipment used to alleviate injury or handicap e g wheelchairs, splints, crutches, special footwear
- Artificial limbs
- Equipment used in treatment of disease or injury e.g. hypodermics, inhalers, bandages, Contraceptive devices
The UK Medical Devices Regulations 1994 introduced the Directive and came into force on the 1st January 1995; the transitional period extends until 13th June 1998, after which medical devices and their accessories must bear a legitimate CE mark.
Competent Authority
The UK Government has appointed the Medical Devices Agency as the UK Competent Authority to regulate the safety of Medical Devices. Other Member States have their own Competent Authorities. It is the duty of a Competent Authority to ensure that the provisions of the Directive are correctly implemented. To assist companies, the Medical Devices Agency provides an excellent set of Guidance Notes explaining the workings of the Medical Devices Directive in the UK. The Competent Authority registers the notified "Notified Bodies" under the Directive.
Notified Bodies
Are certification organisations, which carry out conformity assessment procedures. Under the Directive, Notified Bodies are responsible for any required assessment of Quality Systems, product testing and examination of documentation. Notified bodies are normally restricted to assessing particular types of devices. The Notified Body may subcontract testing to laboratories, but must retain the overall responsibility. The Quality System specifically designed for Medical Devices is EN 46000. This is an interpretation of the widely used ISO9000 series to suit the particular requirements for Medical Devices.
Essential Requirements
The Medical Devices Directive lays down the Essential Requirements for Medical Devices. The essence of these requirements is that the device should be safe for the patient to use and should not hazard any other persons. The precise wording of Annex 1 of the Directive is fundamental to the application of the Directive.
European Norms have been issued to expand and explain the Essential Requirements for particular types of Medical Devices.
EUROPEAN NORMS
For Medical Devices, European Norms are issued at three levels:
- Level 1: General Requirements for a specific sectors of medical devices e.g. technical aids for disabled persons
- Level 2: More specific requirements for families of similar medical devices e.g. wheelchairs
- Level 3: Even more specific requirements for types of medical devices
Often level 2 and 3 are combined in one document. Compliance with particular parts of European Norms can reduce or eliminate a hazard identified in the Risk Analysis.
Risk Assessment and Analysis
An EC Declaration of Conformity for Medical Devices must include the results of the risk analysis. The procedure is contained in EN 1441which is in the process of approval. The essential elements are as follows:
Definitions
- Harm: Physical injury and/or damage to health or property
- Hazard: A potential source of harm
- Risk: The probable rate of occurrence of a hazard causing harm and the degree of severity of the harm
- Safety Freedom from unacceptable risk of harm
Essential Documentation
- Complete Description and Identification of the Device Under Consideration
- List of Possible Hazards
- Method of Reducing Identified Risks to Acceptable Levels
- Identification of the party carrying out the Risk Analysis
PROCESS
A. Identification of Characteristics. List all characteristics, which could affect safety & define limits.
B. Identify all Possible Hazards considering:
- Energy related Hazards e.g. moving parts, electric, heat, vibration etc.
- Biological Hazards e.g. bio-incompatibility, toxicity, hygiene etc.
- Environmental e.g. EMI, contamination by waste products, effects of heat, cold etc.
- Operating Hazards e.g. inadequate instructions or training, human error, etc.
- Function failure, e g mechanical or electrical failure, inadequate maintenance or packaging etc.
C. Estimation of Risk.
Estimate risk for both normal and fault concentrating on most harmfulD. Acceptability of Risk.
Use Harmonised Standards, when issued, to determine acceptability
E. Reduce Unacceptable Risks by:
- Re-design
- Safeguarding e.g. covers
- Instructions or labels describing restrictions
- Redefining the intended use
Review for new hazards and evaluate all.
Finally Assess whether the device is safe.
DEVICE CLASSIFICATION
Under the Medical Devices Directive, Devices are classified according to risk. Devices are grouped into four classes:
- Class I -generally regarded as low risk, covering most non-invasive devices
- Class IIa -generally regarded as medium risk
- Class IIb -generally regarded as medium risk
- Class III -generally regarded as high risk
Each class has its own route for achieving CE Marking. The rules governing the classes are complex and it is wise to consult the Competent Authority for a ruling before starting the CE marking process.
THE VIGILANCE SYSTEM
Under the Medical Devices Directive, manufacturers are bound to report serious incidents involving medical devices, or the recall of any such device. The UK Medical Devices Agency has published the European Commission Guidelines on the Medical Devices Vigilance System, in which it requires manufacturers to submit an initial incident report within ten days and follow this up with a final report detailing the corrective action taken.
COUNCIL DIRECTIVE 93/42/EEC
OF
14 June 1993 Concerning medical devices
Extract from the:
MEDICAL DEVICES DIRECTIVE DEFINITIONS, SCOPE
- This Directive shall apply to medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as medical devices in their own right. Both medical devices and accessories shall hereinafter be termed devices.
- For the purposes of this Directive, the following definitions shall apply:
'medical device' means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software 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 principal 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;
'accessory' means 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;
'device used for in vitro diagnosis' means any device which is a reagent, reagent product, kit, instrument, equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of samples derived from the human body with a view to providing information on the physiological state, state of health or disease, or congenital abnormality thereof;'custom-made device' means any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient.
The above mentioned prescription may also be made out by any other person authorised by virtue of his 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;'device intended for clinical investigation' means any device intended for use by a duly qualified medical practitioner when conducting investigations as referred to in Section 2.1 of Annex X in an adequate human clinical environment.
For the purpose of conducting clinical investigation, any other person who, by virtue of his professional qualifications, is authorised to carry 9ut such investigation shall be accepted as equivalent to a duly qualified medical practitioner;'manufacturer' means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or. on his behalf by a third party.
The obligations of this Directive to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, fully refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name. This subparagraph does not apply to the person who, while not a manufacturer within the meaning of the first subparagraph, assembles or adapts devices already on the market to their intended purpose for an individual patient;
'intended purpose' means 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;
'placing on the market' means the first making available in return for payment or free of charge of a device other than a device intended for clinical investigation, with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished;
'putting into service' means the stage at which a device is ready for use on the Community market for the first time for its intended purpose.
- Where a device is intended to administer a medicinal product within the meaning of Article 1 of Directive 65/65/EEC, that device shall be governed by the present Directive, without prejudice to the provisions of Directive 65/65/EEC with regard to the medicinal product.
If, however, such a device is placed on the market in such a way that the device and the medicinal product form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single product shall be governed by Directive 65/65/EEC. The relevant essential requirements of Annex I to the present Directive shall apply as far as safety and performance related device features are concerned.
- Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of Article I of Directive 65/65/EEC and which is liable to act upon the body with action ancillary to that of the device, that device must be assessed and authorized in accordance with this Directive.
b6b
EN 46000 - A QUALITY SYSTEM FOR
MEDICAL DEVICES b
Introduction
The Standard describing the Quality System for Medical Devices, EN 46001 is based on EN 29001: 1987 which is a version of the current EN ISO 9001: 1994. However, EN 46001 clearly specifies additional requirements that apply to medical devices and these can be added to a quality system fully compliant with ISO 9001, if this is required. EN 46001 includes design whereas EN 46002 excludes a design function. Throughout this document, reference to EN 46001 will be taken to include EN 46002.
When Required for CE Compliance
Since EN 46001 is specific to medical devices, those companies which design and produce medical devices and which require a quality system, are well advised to base their quality system on EN 46001.The Medical Devices Directive, in Annex II describes the "EC Declaration of Conformity" procedure for full quality assurance. This procedure requires a notified body to audit the company's quality system; the system will be audited to the EN 46001 standard, and this audit may also include all the elements of ISO 9001.
For Class I devices, compliance with EN 46001 is not specified although it is advisable. For class II and III devices, except those subject to type examination, EN 46001 is the standard that should be met.
KEY ASPECTS OF EN 46001
EN 46001 is based on a widely accepted quality system but adds particular requirements for medical devices. These include:
- Documentation of Quality Responsibilities
- Advisory Notices and Recall
- Shelf Life and Storage
- Prevention of Contamination
- Sterile Procedures - where necessary
- Retention of Records for the lifetime of the device
- Trace ability and separation of refurbished and production items
- The Regular Review of Sampling Methods
- Identification of Safety Requirements
- Personal Health & Cleanliness
- Cleanliness of the Product
- Environmental Control in Manufacture
- Control of the Technical Files
- Installation Instructions
Most ISO9000 clauses are enlarged to cover the additional requirements of the Directive and to clarify the interpretation of the standard to meet the needs of Medical Devices.
It should be noted that some of these additions are being specified in more detail by European Norms such as EN 1041 which specifies the information to be supplied by manufacturers, or in European Commission Guidelines such as that for Medical Devices Vigilance Systems. When devising a quality system, the first step must be to identify all the related requirements and regulations governing the product, otherwise the system will be based in incorrect procedures.
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