This is an Internet-based document including numerous links to source documents. Updated versions are published regularly on www.swissmedic.ch/md.
This guide was developed by the Swiss Agency for Therapeutic Products, Swissmedic, for assistance of companies that develop, manufacture or distribute in Switzerland medical devices for human use. It summarises the regulation of medical devices in a practical manner, and references important documents and sources of information. Please note, however, that the guide cannot cover all circumstances. The legally binding texts and the standards are authoritative.
Swissmedic recommends the use of this guide to assist in the initial and further education of all persons having regulatory affairs duties and who are responsible for the design, development and quality control of medical devices. More information about medical devices are available at www.swissmedic.ch/md.asp.
In Switzerland, the regulation of medical devices is based primarily on:
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:
The definition of medical devices can be found in Art. 1 MepV. In Switzerland, these are:
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:
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:
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.
For complaints, vigilance incidents and contols, the users, distributors and authorities should be able to identify and contact the companies responsible without delay. The full postal address of the manufacturer in question must be stated on the packaging and also on package leaflets and instructions for use of medical devices. If the manufacturer is not located in one of the contracting States, it is also necessary to state the full address of his authorised representative for the contracting States.
In general, the entire product information must be printed and part of the product. Electronic instructions for use are permissible under certain conditions only. These are defined by European regulations and require full compliance.
A medical device may only be placed on the market by a manufacturer or importer when the applicable conformity assessment procedure is successfully completed. These legal requirements also apply to medical devices which are given away free of charge, rented or used directly on patients.
Conformity assessment procedures have not yet been established for classical or active implantable medical devices with components of human tissue which has been rendered non-viable. This does not absolve the manufacturer however from taking account of appropriate standards for medical devices, as well as from defining specifications for the release and marketing of such products.
A duty to notify the Swiss Agency for Therapeutic Products Swissmedic is to be met for certain medical devices (see Chapter: Notification duties).
The conformity assessment procedure and the notification requirement depend on the risk associated with the product. Each manufacturer or placer on the market must therefore classify all its classical medical devices and in vitro diagnostic medical devices:
(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.)
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:
|-||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)|
The conformity assessment and periodic controls must be carried out with a conformity assessment body:
|-||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|
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:
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:
Humanitarian exemptions: Exemptions can be granted in order to hand out to or use non conforming medical devices on individual patients.
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:
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):
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:
The therapeutic product regulations describe duties of professional users of medical devices (e.g. doctors, nurses, therapists). They must
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)
General considerations: The MepV requires all placers on the market of medical devices (manufacturers, importers, wholesalers, sales outlets, etc.) to maintain a system for post market surveillance of the products (PMS). The purpose of post marketing surveillance is to collect and evaluate information on safety, quality, durability and performance of medical devices during their use. This data is used to identify problems and take any necessary corrective actions. A central element is the collection and evaluation of customer complaints. Other elements can be (depending on the product and health hazards): collection and evaluation of scientific publications, reports from sales/service personnel on visits to customers, information arising from repairs of defective devices, customer surveys concerning satisfaction with the product, post marketing clinical follow-up studies.
Vigilance: Manufacturers and placers on the market of medical devices are required to report to the Swiss Agency for Therapeutic Products Swissmedic any serious adverse events and health hazards, as well as product recalls and related measures taken by the manufacturer. The objective of the incident reporting system (vigilance) is to avoid the repetition of similar incidents. An investigation is carried out if needed by the manufacturer and placer on the market to establish the cause of the incident and to initiate corrective actions. Actions are monitored by the Swiss Agency for Therapeutic Products Swissmedic.
Recalls and other corrective actions, traceability of devices: Where problems arise with medical devices, it is important for the affected company to be able to translate incoming information into measures to be taken by the manufacturer, and to have an effective system for the recall of products, including the tracking of products on the market. Tracking must be ensured at least to own customers and possibly, according to the risk, also to individual patients. There should be a process for communication between manufacturer and distributors.
Export certificates (free sales certificates): Certain countries demand a certificate from the responsible authority in the country of origin before permitting imports or providing approvals. Such certificates for medical devices (only for human use) can be obtained from Swissmedic.
Information on customs matters: The Federal Customs Administration (EZV/AFD) is competent for questions regarding customs matters, including tariffs applicable to the trans-border movement of medical devices.