• medical devices meet essential requirements as regards performance and safety;
• manufacturers, distributors, professional users, conformity assessment bodies and authorities perform specified duties in order to protect patients and third parties from hazards and deception.

In Switzerland, the regulation of medical devices is based primarily on:

• the Federal law on medicinal products and medical devices (Law on Therapeutic Products, Heilmittelgesetz HMG),
• the Medical devices ordinance (Medizinprodukteverordnung MepV),
• the Ordinance on clinical trials of therapeutic products (Verordnung über klinische Versuche mit Heilmitteln VKlin).

These legal texts transpose requirements of the European medical device directives into Swiss law and specify additional national requirements. The therapeutic product regulation is enforced by the Swiss Agency for Therapeutic Products, Swissmedic, and by the Cantonal Authorities in specific areas.

The Swiss Ordinance on the prevention of the transmission of Creutzfeldt-Jakob desease during medical and surgical interventions (CJKV) relies on the Swiss law on epidemics. It prohibits the use of dura mater of human origin and prescribes measures for the decontamination, disinfection and sterilisation of reusable invasive medical devices. These measures are enforced by the cantons.  

Switzerland has concluded treaties with EU Member States, EFTA States and Turkey with regard to the mutual recognition of conformity assessments for medical devices (bilateral agreements or mutual recognition agreements - MRAs) . The basis for these treaties consists of the European CE mark and the application of the European guidelines on medical devices. The States concerned thus recognise the certificates issued by the Swiss conformity assessment bodies, and in return, Switzerland recognises conformity assessments carried out by Notified Bodies / Conformity Assessment Bodies in the States in question.

The treateis simplify the mandatory reporting requirements for placing devices on the market, and permit direct distribution from Switzerland to all EU and EFTA Member States and Turkey, without needing to have an authorised representative with registered offices in the said countries. In return, companies with registered offices in the countries concerned can also distribute compliant medical devices directly to Switzerland. Independently of this, however, country-specific requirements relating to medical devices remain valid (e.g. mandatory notification for new products, requirements regarding the languages in which the product information must be provided, provisions regarding prescription and professional use, distribution channels, sales outlets, advertising, reimbursement by social insurances).

Questions regarding the State contracts can be addressed to the State Secretariat for Economic Affairs (SECO).

Companies should check the specifications of their products and the claims made for the products carefully in order to determine which product regulations apply to them. Medical applications or claims about medical use and medical efficacy are acceptable for medicinal products and medical devices only. Particularly important are the interfaces with the following product regulations:

• Medicinal products
• Foodstuffs and commodities (e.g. toiletries, cosmetics including tooth whiteners, certain products for fitness and wellness)
• Personal protection equipment
• Electrical equipment
• Products for general laboratory use

The definition of medical devices can be found in Art. 1 MepV. In Switzerland, these are:

• Classical medical devices: Correspondig to European directive 93/42/EEC (incl. products containing stable derivatives of human blood or plasma according to directive 2000/70/EC). In Switzerland, products are also included which are derived from human tissue which has been rendered non-viable.
• In vitro diagnostic medical devices: Correspondig to European directive 98/79/EC.
• Active implantable medical devices: Correspondig to European directive 90/385/EEC. In Switzerland, products are also included which are derived from human tissue which has been rendered non-viable.

Certain medical devices can at the same time fall into several areas of law. For these products additional requirements apply. Additional notification duties or registration requirements may have to be fulfilled. Examples:

• Chemical products: medical devices and accessories which are non invasive and do not come into contact with the human body during use must also be classified, packaged and labelled according to directive 1999/45/EC.
• Devices containing mercury or other dangerous substances also fall under the Chemikalien-Risikoreduktions-Verordnung.
• Medical devices producing ionizing radiation also fall under the radiation protection legislation.
• Disinfectants may be medicinal products, medical devices and/or chemical products depending of the use intended by the manufcturer.
• Medical devices with radio signal function also fall under the legislation on telecommunications.
• Pressure equipment and pressure vessels (e.g. medical gas supply systems, sterilisers, compressed air systems) also fall under the ordinances relating to pressure equipment and pressure vessels.
• Medical devices incorporating narcotics: the legislation on narcotics is also applicable.
• Genetic tests: the Swiss federal law on the genetic testing of humans and the DNA profiles act are also applicable.  

The state-of-the art and product requirements should be regularly reviewed in order to form the foundation of successful product development.
 
The Essential Requirements of the European directives concerning medical devices must be met (described in Annex I of the respective directives), which can be ensured and proven by meeting the applicable harmonized standards and instructions of competent authorities.

Harmonised standards: They specify Essential Requirements. These standards can be specific to certain products or describe general methods and requirements (e.g. requirements for risk management for medical devices, requirements for a quality assurance system). The titles and sources of new harmonised standards are announced in the Swiss Official Journal (Bundesblatt / Feuille fédérale). These standards are applicable immediately with no transition period. The latest status of standards development should therefore be closely monitored and taken account of as part of the risk management system. Any necessary corrective actions should be planned in a timely manner.
Meeting standards is not mandatory, yet highly advisable. In case of deviation from the standards, or where suitable standards are not available, the manufacturer must use own data to demonstrate sufficient device safety and performance according to the present state-of-the-art. Deviations from existing standards are seen especially with innovative devices and technologies. In such cases, the necessary investigations (e.g. validations, product comparisons, etc.) can be very resource intensive.

Risk analysis and clinical evaluation: The relationship between benefits to the patient and risks must be tenable according to the present state-of-the-art. A risk analysis is to be carried out (as a rule, according to EN ISO 14971), including an evaluation of the clinical data, where such data are applicable to the particular device. Clinical features claimed have also to be achieved by the device and substantiated by the manufacturer. Clinical trials on patients may be necessary in order to obtain relevant data (see also MEDDEV document on Clinical Evaluation). The risk analysis must be periodically reviewed as the state-of-the-art develops. When riks are not or no longer acceptable according to the state-of-the-art, they must be eliminated primarily by technical modifications.

Official regulations and interpretations: The European Commission and the responsible national authorities can compile interpretations as to the current level of knowledge as well as regulations for various technical aspects. Examples of such regulations are the common technical specifications for in vitro diagnostics and the requirements for medical devices containing components of animal origin. MEDDEV documents are examples of interpretations as to the current level of knowledge. Manufacturers should regularly check for new publications and amendments to these documents.

When a medical devices is systematically tested on humans, this is always regarded a clinical trial in Switzerland. HMG and VKlin describe requirements concerning clinical trials. They transpose the requirements of the European directives for medical devices into Swiss law and regulate national aspects (which is described in the fact sheet on clinical trials and the new therapeutic product legislation). A clinical trial may only commence when the following conditions are met:

1. The investigational device is ready for human use: Requirements are identical to those of the European Community. Also for prototype tests, the device must meet all the non-clinical Essential Requirements. Accordingly, possible risks must be investigated, eliminated whenever possible, or attenuated in other cases, including with the use of protective equipment, training requirements for clinical investigators, careful selection criteria for study subjects. Applicable standards must always be taken into consideration and all necessary investigations in the laboratory and/or on animals must be complete and evaluated (with all relevant aspects covered, e.g. investigation of biological compatibility of materials and substances according to EN ISO 10993-1, production processes, stress tests, implantation techniques, etc.). Investigational devices must be clearly labelled in order to avoid mistaking them for conforming devices. The manufacturer has to document that investigational devices are sufficiently developed. In particular, he must issue the following two documents: Firstly, the statement about conformity to the essential requirements (according to the wording specified in point 2.2. of annex VIII of directive 93/42/EEC, or point 2.2. of annex VI of directive 90/385/EEC, dated and signed). Secondly, information about standards (list of standards applied in full, list of deviations from applicable European harmonised standards, in case of deviations the descriptions of the solutions adopted to meet requirements).
2. The trial is correctly organised: Documentation must be prepared according to VKlin, based on the European medical device directives and on the standards on clinical investigations of medical devices (EN ISO 14155-1 and EN ISO 14155-2). The responsibilities of the parties must be defined and contractually fixed. In particular, Clinical Investigators must be sufficiently trained in Good Clinical Practice, in order for them to carry out all their tasks correctly.
3. The positive decision of the Ethics Committee is present: The positive decision of the Ethics Committee designated by the Canton must be available for each centre where the trial is to be carried out. The vote is acceptable only if all documents listed in art. 9 VKlin have been submitted to the ethics committee. Votes of other ethics committees (e.g. own committees of hospitals, foreign or private ethics committees) are not sufficient.
4. The notification duties are fulfilled: The trial must have been notified to Swissmedic (with the documentation discribed in art. 9 and 14 VKlin) and the confirmation with the official notification number must be available.
   The notification to Swissmedic is not required for certain trails using conforming CE or MD marked medical devices (where conforming devices are used strictly according to their intended purpose and using settings which are already approved for marketing).

Where adverse incidents occur during clinical trials, these are to be reported to the Ethics Committee and also to the Swiss Agency for Therapeutic Products Swissmedic. A report about the safety of the patients and a list of all adverse events which have occurred are to be sent in once yearly during the whole duration of the trial. Also to be reported is the end or termination of a trial.

The term product information covers not only instructions for use but also markings on packaging and products. The minimum content and the essential requirements are defined in European directives and must also be complied with in Switzerland.
 
For sale in Switzerland, the full product information must be given in the German, French and Italian languages. Deviations from this requirement are permissible in two cases only: For custom made devices and for devices, that are delivered solely to professionals. The safety of the persons involved must be guaranteed in all cases. Users must therefore understand the information in the language that is provided and they must aggree with it.
 
In addition to the manufacturer, the responsible for placing the product on the market who is located in Switzerland (or in a country with which Switzerland has an agreement) must also appear.

(Conformity assessment procedures and conformity markings have not yet been established for classical or active implantable medical devices with components of human tissue which has been rendered non-viable.)

a. Manufacturer
 
Compliance with the Essential Requirements is a prerequisite for the conformity assessment by the manufacturer. Written records must be kept for all devices (technical documentation, batch records, etc.). European directives define several procedures for the conformity assessment of medical devices. These also apply in Switzerland. An individual or company which modifies at his own responsibility products which were originally conforming or who places devices on the market under his own name is also considered as a manufacturer.

The conformity assessment can be carried out by the manufacturer itself:

• This is allowed for the following products:
  

  -	all custom made devices (manufactured for one named patient upon written prescription of a qualified professional)
  -	all systems and procedure packs (assembled from conforming products/accessories according to the instructions of the manufacturer)
  -	classical medical devices in class I (non-sterile and without a measuring function)
  -	in vitro medical devices (except devices listed in annex II and devices for self-testing)

• Products have to bear the following markings, showing that conformity assessment requirements have been fulfilled: Custom made devices as well as systems and procedure packs do not carry conformity markings. All other devices bear the CE marking. These products can be placed on the market in the EU/EEA and also in Switzerland as long as the product information is provided in the right languages (see Chapter: "Product information"). Products that are distributed only in Switzerland can be marked with the Swiss MD mark instead of the CE mark.
  

The conformity assessment and periodic controls must be carried out with a conformity assessment body:

• This is compulsory for the following products:

• -	sterile medical devices in class I
  -	medical devices with a measuring function in class I
  -	medical devices in classes IIa, IIb or III
  -	active implantable medical devices
  -	in vitro diagnostic medical devices listed in annex II
  -	in vitro diagnostic medical devices for self-testing

• Specific Swiss conformity assessment bodies as well as equivalent European bodies (Notified Bodies) are presently recognised and must be invoveld by the manufacturer or it's authorised representative. The choice of the conformity assessment procedure depends on the risk of the medical devices and the quality assurance system that is possibly in place. In each case, details should be discussed with the conformity assessment body.
  For medical devices containing medicinal substances and medical devices with components of animal origin, the conformity assessment body will also carry out necessary consultations with national or European authorities.
• Products have to bear the following marking, showing that conformity assessment requirements have been fulfilled:
  "CE" marking followed by the identification number of the responsible body. These products can be placed on the market in the EU/EEA and also in Switzerland as long as the product information is provided in the right languages (see Chapter: "Product information"). Products that are distributed only in Switzerland can be marked with the Swiss MD mark instead of the CE mark.

When the conformity assessment procedure is completed, the manufacturer issues the Declaration of Conformity for the respective product. With the declaration of conformity the manufacturer attests:

• the compliance with the Essential Requirements in the applicable European directive for medical devices (93/42/EEC, 98/79/EEC, or 90/385/EEC),
• when possible the standards and test methods used,
• the Annexes of the European directive according to which the conformity assessment was carried out.

  b. Importer  
  A distributor for Switzerland must assure itself of product conformity and must be able to prove it on demand. Therefore the importer should carefully check the following points:

• Declarations of Conformity of the manufacturers and the completeness of the product information for all languages required (for all devices).
• Existance and validity of Certificates issued by the responsible conformity assessment bodies (EC certificates or MD certificates) for sterile medical devices in Class I, medical devices with a measuring function in Class I, medical devices in Classes IIa, IIb or III, in vitro diagnostic medical devices listed in annex II, in vitro diagnostic medical devices for self-testing, and active implantable medical devices.
  Certificates for medical devices must be issued on the basis of European directive 90/385/EEC, 93/42/EEC or 98/79/EC. Certificates based on e.g. directive 89/336/EEC (electromagnetic compatibility) are not sufficient.

Humanitarian exemptions: Exemptions can be granted in order to hand out to or use non conforming medical devices on individual patients.

c. Documentation
 
It is recommended that documentation is retained for at least 10 years after the last placing on the market (implants for 15 years), longer in certain cases.

Companies and individuals must notify the Swiss Agency for Therapeutic Products Swissmedic when they would like to place one of the following products on the market in Switzerland or in a country affected by a treaty with Switzerland:

• Medical devices in Class I manufactured in Switzerland, or imported into Switzerland from a country not covered by a treaty
• In vitro diagnostic medical devices manufactured in Switzerland, or imported into Switzerland from a country not covered by a treaty
• Manufacturers of custom made devices (devices manufactured for one named patient upon written prescription of a qualified professional)
• Systems or procedure packs (assembly of conforming products/accessories according to the instructions of the manufacturer),

or when they would like to place one of the following medical devices on the Swiss market (applicable to all manufacturers and importers, including those located in the European Union):

• Classical and active implantable medical devices which are derived from human tissue which has been rendered non-viable.

All changes to provided information must be notified to the Swiss Agency for Therapeutic Products Swissmedic once a year.
 
On the other hand, the first placing on the market of medical devices in Classes IIa, IIb and III, and of active implantable medical devices does not have to be notified. Instead, conformity assessment bodies have to be involved with these devices.

Those who issue medical devices to end users are, as defined by the MepV, responsible for placing medical devices in the market. They must:

• Take into account precautionary measures defined by the manufacturer for the storage and delivery of its medical devices.
• Ensure that limitations are correctly met. Certain products are subject to prescription (e.g. medical devices which contain a pharmaceutical subject to prescription, contraceptive intrauterine device IUD and certain swallowable compressed devices for appetite reduction) or may not be issued to the general public (in vitro diagnostic devices for the diagnosis of transmissible diseases in humans).
• They may have to meet operational prerequisites and ensure there is professional consultation available for their customers.
• Participate in product surveillance, forward information about problems with medical devices to those responsible for first placing the devices on the market, and implement corrective actions.

The therapeutic product regulations describe duties of professional users of medical devices (e.g. doctors, nurses, therapists). They must

• Notify severe incidents and severe health hazards with medical devices to Swissmedic.
• Ensure the proper refurbishment and maintenance of medical devices.
  Additionally, measures described in the CJKV must be implemented for the decontamination, disinfection and sterilisation of reusable invasive medical devices.
• Comply with conditions applicable to the use of certain product groups. Currently, there are conditions applicable for injectibale long-term implantable devices and high energy laser devices (both may only be used by medical doctors or under their control and responsibility).
   
  In addition, when ensuring obligations in respect to patient care are adequately met, the correct application of instructions of use can be of major importance.

Sales outlets or other points of delivery as well as places where medical devices are applied on patients may need cantonal authorisations. Information on licenses for the operation of facilities and licences for professional practice can be obtained from the applicable canton, while information on the disposal of medical waste can be obtained from the Federal Office for the Environment (BAFU/FOEN)