Guide to the regulation of medical devices

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.

Swissmedic recommends 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. This document does not claim to be exhaustive, and the legally binding texts and standards are authoritative in every case.

Permanent link of this page
www.swissmedic.ch/md-guide

Overview of the life cycle of a medical device and the various tasks of Swissmedic.
Overview of the life cycle of a medical device and the various tasks of Swissmedic.

Please note that this Guide only applies to legislation based on these EU directives:

  • Directive on active implantable medical devices 90/385/EEC (AIMD)
  • Directive concerning medical devices 93/42/EEC (MDD)
  • Directive on in-vitro diagnostic medical devices 98/79/EEC (IVDD)

Information about the new EU regulations (MDR and IVDR) can be found at this link: New EU regulations (MDR, IVDR)


1. Basics


1.1. Legal basis and international treaties


1.2. Borderline issues

Medicinal products:

Foodstuffs and commodities:

Chemikalien, Chemikalien-Risikoreduktions-Verordnung:

Radiation protection:

Telecommunications:

Pressure euipment:

Electrical equipment:

Desinfectants:

Narcotics:

Genetic tests:

Machines:

Personal protective equipement:


2. Design and development

2.1. Product Design

The state-of-the art and product requirements shall 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).

Harmonised standards:
They specify Essential Requirements and the state of the art. 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 Official Journal of the European Union and in the Swiss Official Journal (Bundesblatt / Feuille fédérale). The latest status of standards development shall 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, but deviations are subject to additional obligations. In case of deviation from the applicable harmonised standards, the manufacturer must describe its own solutions for complying with the Essential Requirements and demonstrate their suitability. Where suitable standards are not available, the manufacturer must develop its own principles for testing and evaluating the products according to the state of the art.

Risk analysis and clinical evaluation:
The relationship between benefits to the patient and risks must be tenable according to the latest criteria. Clinical features claimed have also to be achieved by the device and substantiated by the manufacturer. A risk analysis is to be carried out for every medical device or group of comparable medical devices (as a rule, according to EN ISO 14971), as well as an evaluation of the clinical data, where such data are applicable to the particular device. Clinical trials on patients may be necessary in order to obtain relevant data on the benefits, risks and intended claims (see also MEDDEV 2.7/,1 Clinical Evaluation). Systematic Post-Market Clinical Follow-up may also be needed (see MEDDEV 2.12/2, PMCF). The risk analysis and clinical evaluation must be periodically reviewed as the state-of-the-art develops. When risks 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 and 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.


2.2. Clinical trials of medical devices


2.3. Performance evaluation of in-vitro diagnostic medical devices


2.4. Product information

The term product information also covers instructions for use and the labelling on packaging and products.

Languages: 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 understand the information in the language that is provided and they must agree with it.

Content, addresses: The minimum content and the Essential Requirements are defined in the medical device directives of the EU and must also be observed in Switzerland. For complaints, vigilance incidents and controls, 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 necessary to state the full address of its authorised representative (based in Switzerland or in one of the contracting States.

Electronic instructions for use: 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.

European directives:

Medical devices:

For in vitro diagnostic medical devices:

For active implantable medical devices:

Detailed information in standard EN 1041*:

Address of the manufacturer on medical devices:


3. Market access

Annexes to European directives:

For classical medical devices:

For in vitro diagnostic medical devices:

For active implatable medical devices:


3.1. Classification


3.2. Conformity assessment and marking


3.3. Notification duties according to Article 6 MepV

Mandatory notification for the Swiss-based first placer on the market: Manufacturers, authorised representatives of manufacturers from non-treaty countries (EC-Reps), importers from non-treaty countries (including importing doctors and hospitals), custom-made device producers, system assemblers.
These first placers on the market must notify Swissmedic if they wish to operate with the following devices in Switzerland or in a country that has a treaty with Switzerland.

  • Class I medical devices (including sterile devices and those with a measuring function)
  • In-vitro diagnostic medical devices (see Information Sheet)
  • Custom-made devices (manufactured for a named individual on the basis of a written prescription issued by a qualified person)
  • Systems or procedure packs (assembly of conforming medical devices and accessories according to the instructions of the manufacturer)

All changes to provided information must be notified to the Swiss Agency for Therapeutic Products Swissmedic once a year.

b. Mandatory notification for devitalised human tissue: Anyone wishing to import classical and active implantable medical devices with components from devitalised human tissue into Switzerland must notify Swissmedic. This mandatory notification also applies to devices from the EU. Any changes to notifiable information should be reported to Swissmedic immediately.

c. The first placing on the market of medical devices in Classes IIa, IIb and III, and of active implantable medical devices (provided they are free of devitalised human tissue) does not have to be notified in Switzerland. Instead, conformity assessment bodies have to be involved with these devices.


4. Distribution, dispensation and use of medical devices

4.1. Sales outlets and use of medical devices on patients

The first placing on the market is considered to be when a device is provided or transferred in Switzerland for the first time (Art. 3 Para. 2 MepV). Anyone who imports medical devices into Switzerland and delivers them to trade intermediaries, points of dispensation or patients is the first placer on the market. Further placers on the market distribute or dispense (e.g. to the end user, patient) medical devices which had been put onto the Swiss market by a first placer. They must:

  • Take into account precautionary measures defined by the manufacturer for the storage and delivery of its medical devices.
  • Ensure that the following restrictions on dispensation are observed:
    • Certain products are subject to prescription (e.g. medical devices which contain a pharmaceutical subject to prescription, contraceptive intrauterine devices, certain swallowable compressed devices for appetite reduction). 
    • In vitro diagnostic devices for the diagnosis of transmissible diseases may not be issued to the general public.
    • It is forbidden to supply genetic in vitro diagnostic medical devices to individuals for a purpose which cannot be considered part of those individuals' professional or commercial activities (Art. 9 of the Federal Act on Human Genetic Testing, HGTA, SR 810.12).
  • 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 incidents and severe health hazards with medical devices to Swissmedic.
  • Ensure the proper refurbishment and maintenance of medical devices. For reusable invasive medical devices CJKV also applies (Ordinance on the Prevention of Creutzfeldt-Jakob Disease)
  • Comply with conditions applicable to the use of certain product groups. Currently, there are conditions applicable for long-term injectable devices and high energy laser devices (both may only be used by medical doctors or under their control and responsibility).

When ensuring that obligations in respect of patient care are adequately met, the correct application of instructions of use can be crucial. In the event of deviations, possible consequences should be clarified and a risk analysis prepared.

Points of dispensation 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.

Information on the disposal of medical waste can be obtained from the Federal Office for the Environment (BAFU/FOEN).


4.2. Product surveillance

Product surveillance (Post Market Surveillance, PMS) involves the collection and evaluation of information on the properties of medical devices during their use (safety, quality, durability, performance), the implementation of required corrective actions for the device and, if necessary, the planning and implementation of safety measures in the market. All importers of medical devices (e.g. manufacturers, importers, wholesalers, retailers) are obliged to participate in product surveillance and maintain a functioning product observation system.

PMS information is derived from the following sources in particular:

- The occurrence of incidents on the market (Materiovigilance).
- Customer complaints, e.g. including those from sales personnel.
- Information obtained during maintenance and repair operations.
- The periodic review and assessment of the literature in the relevant specialist area (particularly scientific publications about the specific device, competitor devices, the relevant state of the art in medicine and technology, standards).
- Systematic customer surveys.
- Systematic studies (Post Market Clinical Follow-up, PMCF).

a) Tasks of the first placer on the market (manufacturer, its EU authorized representative, importer),
The first placer on the market is obliged to maintain a functioning PMS system designed to ensure that all relevant PMS information is collected and evaluated, the technical documentation (incl. clinical evaluation report) is periodically updated with data from product surveillance, any investigations and corrective actions are initiated and, if necessary, safety measures are implemented in the market (e.g. recalls, technical updates, warnings to customers). The first placer on the market must report any incidents from Switzerland and safety measures within the time limits to Swissmedic (Materiovigilance and Field Safety Corrective Actions, FSCA). The Materiovigilance System should prevent any recurrence of incidents. The first placer on the market is responsible for investigating the causes of any event and for implementing any safety measures. These operations are monitored by Swissmedic. In the event of problems with medical devices, it is important for the company concerned to be able to translate the information received into safety measures and to operate an effective system for the recall of products and for other safety measures, incl. the traceability of devices in the market. Traceability must be ensured at least down to its own customers. Depending on the risk potential in the individual case, traceability down to the individual patient may also be required. Swissmedic recommends that importers conclude contracts with suppliers and/or manufacturers in order to arrange access to the excerpts from the technical documentation and to define the responsibilities concerning the product surveillance system (Section 5 MepV: Product surveillance, Reporting of incidents and safety measures which are required by the authorities.

b) Tasks of further placers on the market
Other placers on the market include trade intermediaries, pharmacies and other points of dispensation.
They are obliged

- to collect complaints and relevant experience on the use and efficacy of medical devices and send these to the first placer on the market,
- to carry out recalls and other safety measures directly or to forward corresponding information to the individuals concerned (e.g. professional users, patients).

Swissmedic recommends that further placers on the market define and document a process to ensure that complaints and relevant experience are forwarded without any delay to the responsible distributor, importer or manufacturer and recommends to regulate these responsibilities contractually. This avoids any lack of clarity in the communication and collection of information and in the implementation of safety measures.


4.3. Advertising

Principles concerning the admissibility of advertising for medical devices are given in the TPA and the MepV.

  • Misleading statements concerning the efficacy and performance of a medical device are prohibited.
  • For devices issued to the general public, statements on the use, performance and efficacy must be restricted to those contained in the product information.
  • Advertising to the general public is not permitted for medical devices subject to medical prescription or for medical devices placed on the market for exclusive use by professionals.

A general Code of business conduct has been issued by FASMED. This code also takes into account requirements of the Swiss sickness insurance legislation.


5. Social Insurance, VAT, Customs

5.1. Reimbursement by health care schemes

The Swiss Federal Office of Public Health handles questions concerning the reimbursement from Social Insurance and publishes the list of services and equipment delivered to patients (MiGeL/LiMA) and the list of analyses (Analysenliste/Liste des analyses) used in the social sickness insurance scheme.


5.2. Value added tax

The Swiss Federal Tax Administration (FTA/ESTV/AFC) publishes detailed information on the Swiss value added tax (MWST/TVA).


5.3. Trans-border movement of goods

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 ordered, subject to a charge, 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.


6. Further information


* The Swiss Agency for Therapeutic Products Swissmedic is not in a position to provide standards. Standards can be ordered at the Swiss Association for Standardisation SNV , and with Electrosuisse for electrical medical devices.


With certain links offered on this page you will leave the actual domain of Swissmedic. Please note that Swissmedic has no influence on the design and content of the pages addressed by these links and that it accepts no responsibility for them.

Last modification 06.02.2018

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