Frequently Asked Questions on medical devices

According to Art. 3 MedDO medical devices are instruments, apparatus, appliances, software, implants, reagents, materials or other objects that are intended by their manufacturer for use in human beings; that do not achieve their principal intended action in or on the human body either by pharmacological, immunological or metabolic means, but which action can be assisted by such means; and that serve to fulfil one or more of the following specific medical purposes either alone or in combination, e.g. diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, injuries or handicaps; investigation, replacement or modification of the anatomy or of a physiological or pathological process or condition; or the acquisition of information by means of in vitro investigation of samples obtained from the human body, including donated organs, blood or tissue.

Medical devices also include contraceptive or fertility-enhancing products, and items intended specifically to clean, disinfect or sterilise medical devices. Art. 3 para. 2 MedDO

Medical device accessory means any article that is not a medical device in its own right, but which is intended by its manufacturer to be used together with one or more particular medical devices. Art. 3 para. 3 MedDO

Other products within the scope of the MedDO are defined in Art. 1 of the ordinance.

An in vitro diagnostic medical device according to art. 3 IvDO means any medical device in accordance with Art. 3 para. 1 and 2 MedDO which:

a.   is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body; and

b.   solely or principally for the purpose of providing information on one or more of the following:

1.   concerning physiological or pathological processes or states,
2.   concerning congenital physical or mental impairments,
3.   concerning the predisposition to a particular medical condition or a particular disease,
4.   to determine the safety and compatibility with potential recipients,
5.   to predict treatment response or reactions,
6.   to define or monitor therapeutic measures.

Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices.

Accessory for an in vitro diagnostic medical device means an article which, whilst not being itself an in vitro diagnostic medical device, is intended by its manufacturer to be used together with one or more particular in vitro diagnostic medical device(s), to:

a. specifically enable the in vitro diagnostic medical device(s) to be used in accordance with its/their intended purpose(s); or to

b. specifically and directly assist the medical functionality of the in vitro diagnostic medical device or in vitro diagnostic medical devices in terms of its/their intended purpose(s) (Art. 3 IvDO).

• Therapeutic Products Act (TPA; SR 812.21)
• Medical Devices Ordinance of 1 July 2020 (MedDO; SR 812.213)
• Ordinance of 4 May 2022 on In Vitro Diagnostic Medical Devices (IvDO; SR 812.219)
• Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices: EU-MDR (europa.eu)
• Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices: EU-IVDR (europa.eu)
• Guidance - MDCG endorsed documents and other guidance (europa.eu)

An intended medical purpose as well as claims about medical effects are solely permissible for medicinal products and medical devices.

In practice, the distinction between medical devices and the following product groups is particularly important:

• Medicinal products (Human / Veterinary / Complementary and herbal)
• Chemicals Common notification authority for chemicals of the FOEN, FOPH and SECO
• Electrical installations Legal texts
• Food, commodities (e.g. hygiene articles, cosmetics incl. teeth whitening products) FSVO
• Personal protective equipment SECO
• Products that emit non-ionizing radiation and sound NIRSA
• Products that emit ionizing radiation Radiological protection FOPH

Further information on delimitation can be found on our website: Questions on delimitation, as well as in the Information on specific medical devices.

We also recommend you to consult the following Guidance: MDCG 2022-05 Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices.

You can find an overview of the lifecycle of a medical device, the various tasks performed by Swissmedic and information about the regulation of medical devices here: Regulation of medical devices (swissmedic.ch).

For further information, please consult our Questions frequently asked by patients about medical devices (swissmedic.ch), as well as a simplified summary in our videos about medical devices (swissmedic.ch)

Economic stakeholders (MDR: operators) are manufacturers, authorised representatives, importers, distributors and persons referred to in Art. 22(1) and 22(3) EU-MDR (Art. 4 MedDO, IvDO).

We have compiled an information sheet on the obligations of economic operators here.

Any natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark (Art. 4 MedDO, IvDO).

This definition is subject to the clarifying explanations and exceptions set out in Art. 16 para. 1 and 2 of EU-IVDR, EU-MDR (Art. 4 MedDO, IvDO).

Obligations: Art. 46 to 50 MedDO or Art. 39 to 43 IvDO

The requirements for persons placing systems and procedure packs on the market are defined in Art. 11 MedDO. For further information see the FAQ section on systems and procedure packs.

Any natural or legal person established within Switzerland that places a device from abroad on the Swiss market (Art. 4 MedDO, IvDO).
Obligations: Art. 53 MedDO or Art. 46 IvDO

Any natural or legal person in the supply chain, other than the manufacturer or the importer that makes a device available on the Swiss market, up until the point of putting into service market (Art. 4 MedDO, IvDO).
Obligations: Art. 54 MedDO or Art. 47 IvDO

Any natural or legal person established within Switzerland who has received and accepted a written mandate from a manufacturer, located outside Switzerland, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under the Medical devices ordinance (Art. 4 MedDO, IvDO).
Obligations and mandate: Art. 51-52 MedDO or Art. 44-45 IvDO

The designation shall be effective at least for all devices of the same generic device group (Art. 51 para. 3 MedDO in conjunction with art. 11 para. 2 EU-MDR or Art. 44 para. 3 IvDO in conjunction with Art. 11 para. 2 EU-IVDR); Definition for «generic device group»: art. 4 para. 2 MedDO or IvDO in conjunction with art. 2 para. 7 EU-MDR or Art. 2 para. 8 EU-IVDR; and MDCG Guidance 2019-13 no. 3.2, which details the classification of product groups based on EMDN levels).

If the manufacturer is not established within Switzerland, its devices may only be placed on the market if it has appointed an authorised representative in Switzerland (Art. 51 MedDO or Art. 44 IvDO).

If the manufacturer is established in an EU or EEA state or has an authorized representative in an EU or EEA state, the timelines in accordance with Art. 104 MedDO or Art 86 and 87 IvDO apply.

You can find further information on the Swiss authorised representative (CH-REP) here: Swiss authorised representative (CH-REP).

Economic operators are registered according to Art. 55 of MedDO and Art 48 IvDO.

Further information on SRN and CHRN can be found on our website: CHRN – Swiss Single Registration Number

The registration responsibilities for manufacturers, authorised representatives and importers according to EU-MDR and EU-IVDR are detailed in Art. 31 EU-MDR and Art. 28 EU-IVDR.

The 1923 Customs Treaty between Switzerland and the Principality of Liechtenstein effectively created a customs union with the associated principle of open borders. The Annex to the Customs Treaty between Switzerland and Liechtenstein with a reference to the applicable law is adapted every six months in line with the new legislation. The legislation that currently applies to medical devices in the context of the Customs Treaty is the Medical Devices Ordinance of 26 May 2021 (version: 18 October 2022; Annex I to the Customs Treaty) as well as the Ordinance on In Vitro Diagnostic Medical Devices of 26 May 2022 (version: 18 October 2022; Annex I to the Customs Treaty). The applicable legislation was revised on 18 October 2022.

Under the present law, economic operators based in Liechtenstein may act as manufacturers, importers, authorised representatives and distributors in Switzerland.

Manufacturers based in Liechtenstein are not obliged to appoint an authorised representative in Switzerland in order to market their medical devices (see Information sheet on the Obligations of Economic Operators, section 4.2).

According to Art. 55 MedDO and Art. 48 IvDO, an obligation to register applies to manufacturers, authorised representatives and importers. Owing to the revision of the applicable legislation for medical devices and in vitro diagnostic medical devices on 18 October 2022, economic operators based in Liechtenstein must now also register with Swissmedic.

The Definitions of medical devices, in vitro medical devices and accessories thereof are specified in Art. 3 MedDO, IvDO.

Products are classified into classes I, IIa, IIb and III according to Art. 15 MedDO or A, B, C and D according to Art. 14 IvDO, taking into account their intended purpose and the associated risks.

It is the responsibility of the manufacturer to correctly classify his devices. Art. 15 MedDO and Art. 14 IvDO denote that for classification purposes, Annex VIII of EU-MDR and EU-IVDR apply, respectively.

For information on specific medical devices, e.g. 3D printers or software, please consult our website: Information on specific medical devices.

MDCG classification guidance documents:

• MDCG 2021-24 Guidance on classification of medical devices
• MDCG 2019-11 Qualification and classification of software
• MDCG 2020-16 Classification Rules for in vitro Diagnostic Medical Devices

The European Commission, in cooperation with the MDCG (Medical Device Coordination Group), has decided to use the Italian CND nomenclature for Eudamed (European database on medical devices) European Medical Devices Nomenclature (europa.eu),

Further information is provided in the following MDCG guidance documents as well as in information by the European Commission:

• MDCG 2021-12 FAQ on EMDN
• MDCG Guidances EMDN (europa.eu)
• European Medical Device Nomenclature (EMDN) (europa.eu) including EMDN full list

Art. 17 MedDO and Art. 16 IvDO define the requirements for Unique Device Identifiers (UDI) and Art. 65 MedDO and Art. 58 IvDO for recording of the UDI.

The timelines for affixing the UDI are listed in Art. 104 MedDO and Art. 85 IvDO.

Further information can be found on our website: Unique Device Identifier (UDI), in several MDCG guidance documents as well as on the website of the European Commission: Unique Device Identifier (europa.eu).

The person responsible for regulatory compliance (PRRC) verifiably possesses the requisite expertise regarding the requirements for medical devices stated in the MedDO or IvDO and is responsible for ensuring that manufacturers and authorised representatives comply with the regulations.

The obligations of this person, as well as exemptions and further modalities are governed by Art. 15 EU-MDR and EU-IVDR (Art. 49 para. 2 MedDO or Art. 42 para. 2 IvDO).

Manufacturers:

Manufacturers must possess at least one PRRC in their organisation. A deputy PRRC must be defined and ensured, and the PRRC must suffer no disadvantage in relation to the proper fulfilment of their duties (Art. 49 MedDO and Art. 42 IvDO).

Authorised representatives:

Authorised representatives must ensure that they have permanently and continuously at their disposal at least one person who possesses the requisite expertise as regards the requirements for medical devices specified in MedDO and who is responsible for regulatory compliance. Otherwise, paragraphs 2–4 of Art. 49 MedDO apply accordingly (Art. 52 MedDO or Art. 45 IvDO).

Must the PRRC of a Swiss authorised representative or Swiss manufacturer be domiciled in Switzerland?
MedDO and IvDO do not define a requirement for the PRRC to be domiciled in the same jurisdiction in which the authorised representative or manufacturer is domiciled. What is relevant is that the PRRC is organisationally and professionally integrated over the long term and performs its tasks.

Can the manufacturer's PRRC also act for the authorised representative?
MedDO and IvDO do not specify any corresponding requirements, i.e. the possibility that the PRRC of the swiss authorised representative may also be the PRRC of an EC-REP or manufacturer is not ruled out.

Do manufacturers or authorised representatives of devices under the old legislation (AIMDD/MDD/IVDD devices; legacy devices) need to have a PRRC?
No, this is not mandatory. See further information on Art. 15 EU-MDR in MDCG 2021-25, on Art. 15 EU-IVDR in MDCG 2022-8.

Arts. 21–29 MedDO and Art. 17-25 IvDO outline the principles of conformity assessment:

Anyone who places a device on the market or puts a device into service without placing it on the market must, prior to the placing on the market or putting into service, undertake an assessment of the conformity of that device with the general safety and performance requirements.

The conformity assessment procedure is based on Art. 52 and 54 of the EU-MDR, and Annexes IX–XI EU-MDR or on Art. 48 EU-IVDR and Annex IX–XI EU-IVDR (Art. 23 MedDO and Art. 19 IvDO).

The requirements for the consultation of notified bodies and the provisions relating to their certificates of conformity can be found in Art. 24 - 28 MedDO and Art. 21 - 24 IvDO. Further information on designated bodies can be found in Chapter 5 MedDO and Chapter 4 IvDO, and on our website: Designated bodies.

Note: No Switzerland-specific documentation on conformity is required, i.e. stating the CHRN, the Swiss authorised representative or the Medical Devices Ordinance on the certificates of conformity is not mandatory.

The manufacturer draws up a declaration of conformity (Art. 29 MedDO and Art. 25 IvDO), if the applicable conformity assessment procedure has demonstrated that the requirements of MedDO or IvDO are fulfilled and accepts the responsibility for ensuring that the device complies with the requirements of the respective ordinance and all other legal requirements. The manufacturer shall continuously update this declaration. The declaration of conformity contains the information specified in Annex IV EU-MDR or Annex IV EU-IVDR.

For legacy devices (directives 93/42/EEC, 90/385/EEC and 98/79/EC), the declaration of conformity must have been verifiably drawn up for the first time before the date of application* of the respective new regulations. It is important to emphasize that the first issuing of new declarations of conformity in accordance with the old legislation is not permitted after the date of application* of the respective new regulations. A declaration of conformity can only ever be issued in accordance with the current law.

The manufacturer may list non-significant changes affecting the content of an existing declaration of conformity issued under the old legislation either on a document accompanying the declaration of conformity, in analogy to the procedure for non-significant changes affecting certificates issued under the old legislation (MDCG 2020-3), or on the declaration of conformity itself. If changes are made to an existing declaration of conformity issued under the old legislation, these changes must be transparent and traceable to the declaration of conformity that was valid before the new regulation came into force (MDCG 2021-25). In principle, it must be possible to demonstrate that the declaration of conformity issued under the old legislation was lawfully issued before the new regulation came into force (MDCG 2020-2).

* Medical devices (without IVD): MedDO and EU-MDR -> Date of Application: 26 May 2021; IVD: IvDO and EU-IVDR -> Date of Application 26 May 2022

Note: No Switzerland-specific documentation on conformity is required, i.e. stating the CHRN, the Swiss authorised representative or the Medical Devices Ordinance on the declarations of conformity is not mandatory.

The product information includes the label and instructions for use and is based on Annex I Chapter III of EU-MDR or EU-IVDR. It must be drafted in the three official languages. Symbols specified in technical standards can replace verbal statements (Art 16 MedDO and Art. 15 IvDO).

"Label" means the written, printed or graphic information appearing either on the device itself, or on the packaging of each unit or on the packaging of multiple devices (Art. 4 para. 2 MedDO, IvDO in conjunction with Art. 2 point 13 EU-MDR, EU-IVDR.

Swissmedic has compiled the following web pages for the notification of medical devices:

• Notification of medical devices
• Notification of IVD medical devices
• Notification of devitalised human tissue

Please also see the overview summarising the lifecycle of a medical device and the various tasks performed by Swissmedic (Link).

The articles on product registration will come into force later (Art. 110 MeDO or Art. 90 IvDO).

You can find further information on notifying medical devices here: Notification of medical devices

You can find information on the future medical devices database here: Medical devices database

Making available on the market: any supply (transfer) of a device, other than an investigational device, for distribution, consumption or use on the Swiss market in the course of a commercial activity, whether in return for payment or free of charge (Art 4 para. 1 let. a MedDO, IvDO).

Placing on the market: the first making available of a device, other than an investigational device, on the Swiss market (Art 4 para. 1 let. b MedDO, IvDO).

Putting into service: the stage at which a device, other than an investigational device, has been made available to the final user as being ready for use on the Swiss market for the first time for its intended purpose (Art 4 para. 1 let. c MedDO, IvDO).

Section two of MedDO and IvDO, respectively, define the requirements for the placing on the market and putting into service of devices.

• A device may be placed on the market or put into service only, if it meets the general safety and performance requirements set out in Annex I EU-MDR or EU-IVDR, taking into account its intended purpose (Art. 6 MedDO, IvDO).

We have compiled information about market access for medical devices for you here:

• Market access
• Import, sale and distribution
• Conformity assessment (Art. 21 MedDO, Art. 17 IvDO)

Medical devices placed on the market in Switzerland must satisfy the requirements of the Medical Devices Ordinance (MedDO or IvDO):

Information on exemption authorisations for non-conforming medical devices according to Art. 22 MedDO and Art. 18 IvDO can be found on our website: Exemptions for non-conforming medical devices

According to Art. 1 para. 1 let. b and para. 2 MedDO, products without an intended medical purpose (e.g. coloured contact lenses, IPL devices for hair removal, subdermal fillers for anti-wrinkle injections or liposuction devices) fall within the scope of this ordinance. A list of the six current product groups without an intended medical purpose can be found in Annex 1 MedDO.

Further information on the product groups specified in Annex 1 MedDO can be found here

We have compiled an overview regarding regulation, qualification, classification and the relevant regulations for software in our information sheet: Information sheet Medical Device Software

Further information is provided in the following MDCG guidance documents:

• Is your software a Medical Device?
• MDCG 2020-1 Clinical and Performance Evaluation
• MDCG 2019-16 Cybersecurity for medical devices
• MDCG 2019-11 Qualification and classification of software

You can find information on the revised requirements for combination products (medicinal products with a medical device component) here:

• Revised requirements regarding combination products (swissmedic.ch)
• Practical interpretation – Swiss authorised representative (CH-REP) for combination products (swissmedic.ch)
• Practical interpretation – Requirements for importers under the Medical Devices Ordinance in the case of combination products (swissmedic.ch)

"Custom-made device" means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional qualifications which gives, under that person's responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs.

However, mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices (Art. 4 para. 2 MedDO; Art. 2 para 3 EU MDR).

According to Art. 10 MedDO, the requirements stated in Annex XIII EU MDR apply. When placed on the market, a custom-made device must be accompanied by the statement specified in Annex XIII section 1 EU-MDR.

In addition Art. 10 MedDO specifies the requirements for custom-made devices pertaining to conformity assessment and documentation.

Art. 19 MedDO defines the corresponding notification obligations.

See also: Notification of medical devices (swissmedic.ch)

The MDCG provides further information in a Questions and Answers document: MDCG 2021-3

"Procedure pack" means a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose (Art. 4 para. 2 MedDO; Art. 2 para. 10 EU-MDR).

"System" means a combination of products, either packaged together or not, which are intended to be inter-connected or combined to achieve a specific medical purpose (Art. 4 para. 2 MedDO; Art. 2 para 11 EU-MDR).

Requirements relating to the placing on the market of systems and procedure packs are defined in Art. 11 of MedDO.

For further requirements, please refer to the following provisions in MedDO:

• Art. 17 MedDO UDI requirements
• Art. 51 para. 5 MedDO Obligations of authorised representatives
• Art. 55 MedDO Registration of economic operators
• Art. 66 MedDO Vigilance reporting obligation
• Art. 104a para. 2 MedDO Timeline for appointing an authorised representative by 31July 2022
• Art. 108 MedDO Reporting obligations

The MDCG also provides information about UDIs for systems and procedure packs:

• MDCG 2018-3 UDI for systems and procedure packs
• MDCG 2018-4 UDI core elements for systems and procedure packs

For implantable devices, the manufacturer must provide, in addition to the product information stated in Art. 16, the information stated in Art. 18 para. 1 of EU-MDR, including the implant card (Art. 20 MedDO).

Further information is available in the following MDCG guidance documents and the factsheet issued by the European Commission:

• MDCG 2019-8 Implant Card
• MDCG 2021-11 Implant Card - Device types
• Factsheet for Manufacturers of Implantable Medical Devices (Link).

In-house medical devices (according to MedDO)
Art. 9 MedDO defines the requirements relating to devices manufactured and used in healthcare institutions:

Provided the requirements of Art. 5 para. 5 EU-MDR  are fulfilled, the relevant general safety and performance requirements stated in Annex 1 EU-MDR apply to devices that are manufactured and used solely within healthcare institutions and not manufactured on an industrial scale, but not the further requirements of MedDO.

Art. 18 MedDO defines the obligations to report the aforementioned devices to Swissmedic before they are put into service. Further information can be found on our website: Notification of medical devices.

Further information for healthcare professionals and health institutions can be found in the corresponding European Commission factsheet (Link).

In-house IVD (according to IvDO)

In-house IVDs comprise in vitro diagnostic medical devices (IVDs) and their accessories that are manufactured and used solely within healthcare institutions. Art. 9 IvDO in conjunction with Art. 5 para. 5 EU IVDR defines the main requirements for in-house IVDs and for the healthcare institutions that manufacture and use them. For in-house IVDs, the relevant general safety and performance requirements according to Annex I EU IVDR apply, but not the further requirements of the IvDO, provided that the requirements according to Art. 5 para. 5 let. a-i EU-IVDR are fulfilled.

A comprehensive description of in vitro diagnostic medical devices can be found on our website: What is an in vitro diagnostic device according to IvDO? Healthcare institutions include, among others, hospitals and medical laboratories.

In-house IVDs include, for example (list not exhaustive):

i) Medical analytical tests developed in-house, e.g. based on standard procedures or scientific publications;

ii) IVD software* developed in-house;

iii) CE-marked IVDs that are used outside of the intended purpose defined by the manufacturer;

iv) Medical analytical tests that include commercially available products that are not CE marked (e.g. Research Use Only products, also called RUO);

v) Combinations of multiple CE-marked IVDs that are not intended to be used together according the intended purpose of the manufacturer.

*Further information about medical device software can be found on our website: Medical Device Software.

The following examples are not in-house IVDs (list not exhaustive):

i) Test procedures with CE-marked IVDs that are implemented according to the directions of the IVD manufacturers

ii) Products for general laboratory use

iii) Products intended for research use only

Requirements accoording to Art. 5 Abs. 5 Bst. a-i EU IVDR

a. the devices are not transferred to another legal entity;

It must be decided on a case-by-case basis whether a legally independent facility exists. In principle, this is assumed to be the case if the facility is legally, economically and organizationally independent.

b. manufacture and use of the devices occur under appropriate quality management systems;

The healthcare facility must ensure that both aspects of manufacture and aspects of use are covered by the quality management system and establish functional processes for this purpose, as well as have complete traceability through appropriate documentation and records. The MDCG 2023-1 Guidance document can be used as an orientation for appropriate quality management.

c the laboratory of the health institution is compliant with standard EN ISO 15189 or where applicable national provisions, including national provisions regarding accreditation;

d. the health institution justifies in its documentation that the target patient group's specific needs cannot be met, or cannot be met at the appropriate level of performance by an equivalent device available on the market;

A justification of non-equivalence may be based, for example, on technical, biological or clinical aspects of the device (see MDCG 2023-01 for details). The term market is understood here to mean the Swiss market.

e. the health institution provides information upon request on the use of such devices to its competent authority, which shall include a justification of their manufacturing, modification and use;

f. the health institution draws up a declaration which it shall make publicly available, including:

I. the name and address of the manufacturing health institution,

II. the details necessary to identify the devices,

III. a declaration that the devices meet the general safety and performance requirements set out in Annex I of the EU-IVDR and, where applicable, information on which requirements are not fully met with a reasoned justification therefor;

The declaration may, for example, be published on the healthcare institution's website or in its list of analysis. A template can be found in MDCG 2023-1 under Annex A.

g. the health institution draws up documentation that makes it possible to have an understanding of the manufacturing facility, the manufacturing process, the design and performance data of the devices, including the intended purpose, and that is sufficiently detailed to enable the competent authority to ascertain that the general safety and performance requirements set out in Annex I to this Regulation are met;

These documents are required for the devices of all classes.

h. the health institution takes all necessary measures to ensure that all devices are manufactured in accordance with the documentation referred to in point (g);

i. the health institution reviews experience gained from clinical use of the devices and takes all necessary corrective actions.

Requirement under (a) is applicable as of May 26, 2022. Requirements under (b), (c), (e), (f), (g), (h) and (i) are applicable from 26 May 2024. Requirement according to letter d is applicable as of May 26, 2028 (Art. 83 IvDO).

The document MDCG 2023-1 on the website of the EU Commission (Guidance - MDCG endorsed documents and other guidance (europa.eu))contains further information on the requirements according to Art. 5 para. 5 let. a-i EU IVDR.

General Information

In-house IVDs are considered to be put into service, but they are not considered to be placed on the market. They must not be manufactured on an industrial scale (note: this is understood to mean that the production volume of an in-house IVD does not exceed the demand of the health institution calculated for a given time period). Certification by a designated body is not required. Assigning and affixing a UDI is also not required. Product information may be limited to fewer than three official languages or to English.

Notification of In-house IVDs

In-house IVDs have to be notified to Swissmedic according to Art. 10 IvDO before they are put into service. Further information can be found on our website: Notification of IVDs.

Further Obligations of healthcare institutions

Vigilance

Any professionalwho becomes aware of a serious incidentwhen using devices must reportthis to Swissmedic” (Art. 59 para. 4 IvDO). Hospitals must set up an internal reporting system within the framework of an established quality management system for the purpose of reporting under Article 59 paragraph 4 IvDO (Art. 60 para. 1 IvDO). Further information can be found on our website: Reporting incidents & FSCAs (vigilance).

Maintenance

Any professional using devices must ensure that the devices are maintained and tested in accordance with the regulations (Art. 64 para. 1 IvDO).

Cybersecurity

Healthcare institutions must put in place all technical and organisational resources required by the state of the art to ensure that network-compatible devices are protected against electronic attack and unauthorised access” (Art. 65 para. 1 IvDO).

Microbiological laboratories

Laboratories that perform microbiological analysis for the purpose of detecting or excluding human transmissible dieseases require an establishment license issued by Swissmedic based on Art. 16 Epidemics Act (EpidA). Licensed microbiological laboratories are regularly inspected by the licensing authority Swissmedic based on the requirements of the Ordinance on microbiological laboratories and its annexes. Further information on the requirements of the Ordinance on Microbiological Laboratories can be found on our website: Explanations.

Transitional provisions and timelines are defined in Chapter 11 section 2 of MedDO, Chapter 10 section 2 of IvDO, Art. 120 of EU MDR and Art. 110 EU-IVDR.

You can find detailed information in our leaflet for economic operators (link)

Items in the manufacturer's warehouse

The relevant requirements for devices must be fulfilled at the time of placing on the market (definition according to Art. 4 para. 1 let. b MedDO, IvDO). Devices in the manufacturer's warehouse are not yet placed on the market. Consequence: "Stock sell-off", e.g. after expiry or withdrawal of the designated body's certificate, is not possible.

Stock items in general and stating the CH-authorised representative or CH-importer on the device

The relevant requirements for devices must be fulfilled at the time of placing on the market (definition according to Art. 4 para. 1 let. b MedDO, IvDO), including details of the CH-economic operators.

Devices that were imported or already in the distributor's warehouse before the new regulations entered into force* are considered to have been placed on the market in the European context according to the provisions of the old legislative and may continued to be made available on the market up to the dates detailed in the regulations depending on the type and classification of the product (Art. 101 para. 3 MedDO and Art. 82 IvDO). The importer or CH-authorised representative does not need to be stated retrospectively.

Devices imported / in the warehouse after the new regulations entered into force* : Transitional provisions apply to the indication of the CH-authorised representative and the CH-importer (for more information see Chapter 6 of the Information sheet, Obligations Economic Operators CH.

Upon expiry of the transitional provisions applicable to the relevant devices, the importer may place these on the market only if the labelling requirements are satisfied, even if the device had been imported before the expiry of the deadlines.

Devices that have been transferred/supplied to the distributor on the Swiss market were placed on the market. These can therefore continued to be made available on the market, but devices compliant with the old legislation only until the dates detailed in the regulations depending on the type and classification of the product (Art. 101 para. 3 MedDO and Art. 82 IvDO).

* Medical devices (without IVD): MedDO and EU-MDR -> Date of Application: 26 May 2021;
   IVD: IvDO and EU-IVDR -> Date of Application 26 May 2022

In 2018 (before the date of application of MDR was postponed), the CAMD published a list of FAQs on the transitional provisions in the MDR and IVDR:

• CAMD FAQ– MDR Transitional provisions
• CAMD FAQ – IVDR Transitional provisions

Further information on the application of the EU MDR transitional provisions can be found in the following MDCG guidance documents as well as in the documents and factsheets provided by the European Commission:

• MDCG 2019-10 Application of transitional provisions concerning validity of certificates
• MDCG 2019-15 Market access for manufacturers of class I medical devices
• MDCG 2020-2 Application of transitional provisions for class I medical devices
• MDCG 2021-4 Application of transitional provision for certification of class D IVDs
• MDCG 2021-25 Application of MDR requirements to "legacy devices" and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC
• MDCG 2022-8 - Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022
• MDCG 2022-6 Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR
• Factsheet for manufacturers of medical devices (europa.eu)
• Step-by-step guide for medical device manufacturers (europa.eu)
• Factsheet for Class I - Medical Devices (europa.eu)
• Factsheet for manufacturers of in vitro diagnostic medical devices (europa.eu)
• Step-by-step guide for manufacturers of in vitro diagnostic medical devices (europa.eu)
• Factsheet for authorised representatives/importers/distributors (europa.eu)
• Factsheet for healthcare professionals and health institutions (europa.eu)

Any specific questions on the MRA (extension of the existing agreement, updating in line with the MDR, etc.) and international agreements should be addressed to SECO.

MRA Switzerland - EU

MRA Switzerland - UK
(www.seco.admin.ch)