DIRECTIVE 93/42/EEC FOR MEDICAL DEVICES
- Regulations
- Scope and Classification of Devices
- Certification Options
- Technical Documentation
- Quality Systems
- Local Distributors, Licenses and Registration
- Future Developments
- SGS Certification
- SGS Training
- Contact SGS
The medical devices directive (MDD) 93/42/EEC was the second medical devices directive and was fully implemented in June 1998. It covers all medical devices used on humans not covered by the other two directives. This covers the majority of medical devices sold. Notified Body certification is required for all Class 1 (sterile or measuring function), Class IIa, Class IIb and Class III devices. A few medical devices are also covered by other EC Directives and manufacturers must then comply with both Directives.
Scope and Classification of Devices
As the scope of this directive is wide, covering medical devices as diverse as electrical equipment, wound dressings, implants, sterile single use products and disinfectants, it potentially overlaps with many other EC regulated products. These other regulated products include cosmetics, pharmaceuticals, biocides, consumer products and personal protective equipment some of which are CE marked and some of which must not be CE marked. It is illegal to CE mark a product that should not be CE marked, illegal to CE mark under the incorrect directive and illegal not to use the CE mark when required.
Most products that are covered by this directive are classified into four classes of increasing risk, Class I, IIa, IIb and III. Directive 93/42/EEC contains 19 rules in Annex IX that allow correct classification but interpretation needs experience and knowledge of the many guidance documents. Classification is important to allow the choice of the correct Notified Body certification.
Certain small groups of devices are covered by this directive but do not need CE marking including devices for clinical investigation, custom made devices and systems/procedure packs.
As both the scope and classification of medical devices is complicated, it is essential that manufacturers new to CE marking seek advice at an early stage.
The choice of Notified Body certification depends on the device classification and is often determined by the highest class of device that a manufacturer makes. The most popular certification is Annex II followed then by Annex V and these options are the most cost-effective for most manufacturers.
| Options | |
| Class I sterile | Annex II or V |
| Class I (measuring) | Annex II, IV, V, or VI |
| Class IIa | Annex II, IV, V or VI |
| Class IIb | Annex II or Annex III + IV, + III + V or + III + VI |
| Class III | Annex II or Annex III + IV or III + V |
| Annex II = | Full Quality Assurance, audits of the full QMS |
| Annex III = | EC Type Examination, type testing by the Notified Body |
| Annex IV = | EC Verification, batch or 100% testing by the Notified Body |
| Annex V = | Production Quality Assurance, audits of the QMS excluding design |
| Annex VI = | Product Quality Assurance, audits of the QMS excluding design and manufacture. Own Brand Labelers also require certification to the appropriate annex. |
Manufacturers must prepare technical documentation in a European language to support compliance of the device with the Essential Requirements of the Directive. European Harmonized Standards exist for many types of devices and generic features and compliance by manufacturers is important, although not a legal requirement. EC guidance on technical documentation is available and must be followed by manufacturers wishing to CE mark. Clinical evaluation and risk management documentation is a mandatory part of this technical documentation.
The technical documentation is assessed by a Notified Body for all classes of device except Class I (non sterile, non measuring function) as part of Full Quality Assurance (Annex II), EC Type Examination (Annex III), EC Verification (Annex IV), Production Quality Assurance (Annex V) or Product Quality Assurance (Annex VI) certification.
ISO 13485:2003 is the harmonized standard for quality systems compliance under this directive, but the extra requirements of this directive must also be included. In all cases with the exception of Annex IV, an audit of the QMS is required by the Notified Body before certification and CE marking. Own brand labelers may obtain CE Mark certification with a limited QMS.
Local Distributors, Licenses and Registration
Under 93/42/EEC manufacturers within EU only have to register Class I, custom made devices and system/procedure packs, but some individual European countries require registration of a wider range of devices. However, there are no medical device licenses required in the EU.
Manufacturers outside the EU have to appoint an Authorized Representative within the EU (legally required from 21/3/2010) and their name and address must appear with the manufacturer's name and address on the labeling. However, the legal responsibilities of the Authorized Representative are flexible and may be limited.
From 21 March 2010, directive 93/42/EEC is amended by directive 2007/47/EC. This new directive is significant, and changed requirements include classifications, certification options, Essential Requirements, clinical evaluation, Authorized Representatives, custom-made devices, labeling and confidentiality. All manufacturers must comply from 21 March 2010 and all certification dated after 21 March 2010 will include the requirements of 2007/47/EC.
SGS United Kingdom is Notified Body 0120 for all medical devices under this directive and SGS has a global network of approved auditors who can undertake CE mark audits. CE marking audits can be undertaken on their own or in conjunction with other SGS medical device audits.
SGS can also provide certification under Annex III and IV for some devices. CE 0120 cannot be used until the required SGS certification is issued.
SGS offers in house and public training on 93/42/EEC and the changes needed to the quality system and the technical documentation to ensure compliance. Gap analysis audits can also be undertaken.
Advice on the medical devices directive 93/42/EEC including scope, a device classification and certification option is available from SGS.
This summary should not be taken as a definitive description of the requirements as regulations and interpretations do change and this is intended to be an outline only. Manufacturers must verify the requirements that apply to them before proceeding.
