Information sheet

Obligations Economic Operators CH

Contents
1 Introduction .......................................................................................................................1
1.1 Revision of medical devices law ..........................................................................................1
1.2 Scope ..................................................................................................................................2
2 Basis and abbreviations ...................................................................................................2
2.1 Legal basis ..........................................................................................................................2
2.2 Abbreviations .......................................................................................................................2
2.3 Operators and concepts ......................................................................................................3
3 Placing devices on the market and economic operators................................................3
4 Transitional provisions .....................................................................................................5
4.1 Placing devices on the market according to Directive 93/42/EEC or Directive 90/385/EEC
("legacy devices") ................................................................................................................5
4.2 CH-REP...............................................................................................................................5
5 Obligations.........................................................................................................................6
6 Indication of the manufacturer, CH-REP and importer ...................................................9
7 Translation of product information and repackaging ...................................................11
8 Frequently asked questions ...........................................................................................11
9 Further information .........................................................................................................12

1 Introduction
1.1 Revision of medical devices law
The Federal Council enacted Switzerland’s revised medical devices legislation on 26 May 2021. To
ensure that quality, safety and efficacy standards match those in EU member states, this legislation is
based on the new EU Regulation on medical devices (MDR 1). The European Regulation on in vitro
diagnostics (IVDR 2) is due to be implemented in Switzerland on 26 May 2022.
Under the previous regulations (Directives 90/385/EEC, 93/42/EEC and 98/79/EC), the Swiss-EU
agreement on the mutual recognition of conformity assessments (Mutual Recognition Agreement or
MRA) gave Switzerland access to the European single market for medical devices on an equal
partnership basis. As a result, Switzerland was able to effectively and efficiently perform market
surveillance by working in cooperation with the relevant authorities in the EU member states, and thus
avoid technical barriers to trade between both parties. Moreover, Swiss patients benefited from
access to the full range of medical devices available in Europe.

The MRA was due to be updated concurrently with the entry into force of Switzerland’s new medical
devices regulation. However, the EU Commission decided not to proceed any further with updating
the agreement with effect from 26 May 2021 owing to the broader political context (discontinuation of
the negotiations on the institutional framework agreement between Switzerland and the EU).

1 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending
Directive 2001/83/EC, Regulation (EC) No. 178/2002 and Regulation (EC) No. 1223/2009 and repealing Council Directives
90/385/EEC and 93/42/EEC, OJ L 117, p. 1 (Medical Device Regulation, MDR)
2 Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro-diagnostic medical

devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU, OJ L 117, p. 176 (In Vitro Diagnostic
Medical Devices Regulation, IVDR)
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Since the MRA has not been updated, Switzerland has established measures designed to limit the
negative consequences of this development, particularly the inability of the Swiss authorities to
access the European database for medical devices (Eudamed 3) and the lack of cooperation in
market monitoring. These include e.g. the staggered timelines for appointing an authorised
representative ("CH-REP"), the need for economic operators to register with Swissmedic, the
reporting of serious incidents to Swissmedic and the recognition of EU certificates of conformity in
Switzerland.
1.2 Scope
This information refers to medical devices, their accessories and products without an intended
medical purpose3 according to Art. 1 of the Medical Devices Ordinance (MedDO; SR 812.213). For
the purposes of this information sheet, the term "devices" is used generally to refer to these products.
For in vitro diagnostic medical devices, the provisions of the old law continue to apply (see Art. 105
MedDO).

This information sheet refers exclusively to economic operators established in Switzerland and to
devices that are made available on the market in Switzerland.

2 Basis and abbreviations

2.1 Legal basis
TPA Therapeutic Products Act; SR 812.21
MedDO Medical Devices Ordinance of 1 July 2020; SR 812.213
oMedDO Old (former) Medical Devices Ordinance of 17 October 2001 (version of 1
August 2020)
MDR Regulation (EU) 2017/745 of the European Parliament and of the Council of 5
April 2017 on medical devices
IVDR Regulation (EU) 2017/746 of the European Parliament and of the Council of 5
April 2017 on in vitro diagnostic medical devices

2.2 Abbreviations
SRN EU Single Registration Number, assigned according to Art. 31 MDR
CHRN Swiss Single Registration Number (CH identification number) assigned
according to Art. 55 MedDO
TD Technical Documentation
UDI Unique Device Identification
CH Switzerland
EO Economic operators
MDD/AIMDD Device that has been CE-marked under the former regulations (Directive
device 93/42/EEC concerning medical devices or Directive 90/385/EEC on active
implantable medical devices). Often also referred to as "legacy device".
MDR device Device that has been CE-marked according to the MDR

3 Information on medical devices without an intended medical purpose (Annex I MedDO and Annex XVI MDR) can be found

at www.swissmedic.ch > Medical devices

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2.3 Operators and concepts

Manufacturer 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.
The manufacturer's obligations also apply to persons who carry out the
activities specified in Art. 16 para. 1 MDR; Art. 4 para. 1 let. f MedDO.
CH-REP Authorised representative; natural or legal person in Switzerland who has been
mandated in writing by a manufacturer established in a foreign country to
act on the manufacturer's behalf in relation to specified tasks in accordance with
MedDO; Art. 4 para. 1 let. g MedDO
CH-importer Natural or legal person in Switzerland that places a device from a foreign
country on the Swiss market; Art. 4 para. 1 let. h MedDO.
CH-distributor 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; Art. 4 para. 1 let. i MedDO.
Contracting States with which Switzerland has concluded an MRA; Art. 4 para. 1 let. m
state MedDO.
EU/EEA state Member states of the European Union, Iceland, Liechtenstein and Norway.
United Kingdom and Turkey are not EU/EEA states.
CH-EO Economic operator established in Switzerland / established in the European
EU-EO Union. Collective term for manufacturer, authorised representative, importer,
distributor (Art. 4 para. 1 let. j MedDO).

3 Placing devices on the market and economic operators

The following graphic and corresponding captions explain the roles of the economic operators using
the example of a foreign manufacturer with a Swiss supply chain. Other configurations (e.g. transfer /
supply of products for the public from distributors to patients, supply chains without distributors in
Switzerland) are also possible.

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Authorised representative 4 in CH (Art. 4 para. 1 let. g MedDO)

Is appointed in writing by the manufacturer (mandate) to act on the manufacturer's
behalf in relation to specified tasks.
If the manufacturer of a device is not established in Switzerland, its devices may only be
placed on the market once an authorised representative established in Switzerland has
been designated 5. This also applies to manufacturers established in the EU/EEA.
The designation shall be effective at least for all devices of the same generic device
group 6.
CH-importer (Art. 4 para. 1 let. h MedDO)
An importer is not "designated", but its role arises from the activity that is carried out
when a natural or legal person places a device from a foreign country on the Swiss
market.
CH-distributor (Art. 4 para. 1 let. i MedDO)
Economic operator in the supply chain, other than the manufacturer or importer, who
makes a device available on the market, up to the stage of putting it into service.
Making available on the market (Art. 4 para. 1 let. a MedDO)
Collective term referring to the transfer or supply of a device.
The use of a product by a professional user (e.g. a device or dressing material) does not
mean making available on the market.
The making available of a product supposes an offer or an agreement (written or verbal)
between two or more legal or natural persons for the transfer of ownership, possession or
any other right concerning the product in question after the stage of manufacture has
taken place 7. The transfer does not necessarily require the physical handover of the
product. This transfer can be for payment or free of charge.
Placing on the market (Art. 4 para. 1 let. b MedDO)
First making available of a device on the Swiss market (e.g. via a transfer or supply
between economic operators or from a Swiss economic operator to a healthcare facility /
the consumer).
The concept of placing on the market refers to each individual device, not to a type of
device 8. Consequently, each individual device is placed on the market even if devices of
the same model or type have already been placed on the market.
Putting into service (Art. 4 para. 1 let. c MedDO)
The stage at which the device is made available to the final user / healthcare facility for the
first time.
Healthcare facility (Art. 4 para. 1 let. k and l MedDO)

Product

Manufacturer (Art. 4 para. 1 let. f MedDO)

4 The symbol can be downloaded from www.swissmedic.ch > Medical devices

5 Art. 51 para. 1 MedDO
6 Art. 51 para. 3 MedDO in conjunction with art. 11 para. 2 MDR

Definition for «generic device group»: art. 4 para. 2 MedDO in conjunction with art. 2 para. 7 MDR and MDCG 2019-13 no.
3.2
7 See chapter 2.2 of the “The ‘Blue Guide’ on the implementation of EU products rules 2016”, OJ C 272, 26.7.2016
8 See chapter 2.3 of the “Commission Notice - The ‘Blue Guide’ on the implementation of EU products rules 2016”, OJ C

272, 26.7.2016
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4 Transitional provisions
4.1 Placing devices on the market according to Directive 93/42/EEC or Directive
90/385/EEC ("legacy devices")
The new Medical Devices Ordinance entered into force on 26 May 2021 and basically applies to all
devices. Certain devices that comply with the old legislation and were CE-marked according to
oMedDO or Directive 93/42/EEC or Directive 90/385/EEC may continue to be placed on the market,
or made available on the market, even after the entry into force of MedDO, provided certain
conditions are met 9 (so-called "legacy devices").
This exemption concerns the following devices:
- Class I devices with a declaration of conformity issued before 26 May 2021, for which a certificate
(i.e. involvement of a notified body) is required according to the new regulations (e.g. reusable
surgical instruments 10, devices classified in a higher class according to MDR); or
- Devices with a valid certificate 11 (“CE certificate”) under the old regulations.
Provided these devices comply with the relevant directive and have not undergone any significant
changes in their design or intended purpose 12, they may be placed on the market after 26 May 2021
until the certificates expire, but in any case not later than 26 May 2024. They may continue to be
made available in the distribution chain until 26 May 2025.
After 26 May 2025 no devices covered by the old regulations may be made available on the market.
4.2 CH-REP
The following timelines apply to manufacturers established in an EU/EEA state or which have an
authorised representative in an EU/EEA state for designating a Swiss authorised representative 13.

 High-risk devices (Class III, IIb implantable and AIMD): 31 December 2021
 Moderate-risk devices (non-implantable Class IIb, Class IIa): 31 March 2022
 Low-risk devices (Class I): 31 July 2022
 Systems and procedure packs: 31 July 2022

EEA states are the member states of the EU, Iceland, Norway and Liechtenstein. However, the
timelines only apply to EU states, Norway and Iceland. Due to the customs treaty 14 between
Liechtenstein and Switzerland, a manufacturer in Liechtenstein is not obliged to designate an
authorised representative in Switzerland.

All other foreign manufacturers are required to appoint a Swiss authorised representative with effect
from 26 May 2021. These provisions apply both to MDD/AIMDD and MDR devices.
See section 6 for information on indicating the CH-REP "on the device" or in a document
accompanying the device (including deadlines).

9 Art. 101 MedDO

10 Art. 23 MedDO and Art. 52 para. 7 letter c MDR
11 Art. 10 para. 1 in conjunction with Annex 3 MedDO
12 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices

covered by certificates according to MDD or AIMD, MDCG 2020-3

(https://ec.europa.eu/health/md_sector/new_regulations/guidance_en)
13 Art. 104a MedDO
14 Art. 1 of the Vertrag zwischen der Schweiz und Liechtenstein über den Anschluss des Fürstentums Liechtenstein an das

schweizerische Zollgebiet (SR 0.631.112.514)

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5 Obligations
The table provides an overview of the obligations of Swiss authorised representatives, importers and distributors.
The cited provisions from MDR are applicable according to Art. 6 para. 2, 51 para. 3, 53 para. 4 and 54 para. 4 MedDO.

# Obligation CH-REP CH-importer CH-distributor

1 Basic information Responsible for the formal and safety- May only place devices on the market In the context of its activities, act with
related issues connected with the that comply with MedDO. due care in relation to the applicable
placing on the market of the device. Art. 53 para. 1 MedDO requirements.
Art. 51 para. 2 MedDO Art. 54 para. 1 MedDO

Keep available the technical

documentation or contractually agree
that the manufacturer shall, on request,
submit the documentation directly to
Swissmedic within 7 days.
Art. 51 para. 3bis MedDO
2 Legal references for the obligations Art. 51 and 52 MedDO Art. 53 MedDO Art. 54 MedDO
Art. 11 MDR Art. 13 MDR Art. 14 MDR
Art. 55 para. 3 MedDO / Art. 30 para. 3
MDR (verification of registration)
3 Written mandate with manufacturer Required No obligation No obligation
Art. 51 para. 1 MedDO
Art. 11 paras. 3 and 4 MDR
4 Person Responsible for Regulatory Required No obligation No obligation
Compliance in the organisation (PRRC) Art. 52 para. 1 MedDO
PRRC requirements, Art. 49, paras. 2-4
MedDO

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# Obligation CH-REP CH-importer CH-distributor
5 Registration of the economic operators/ Required Required No / not possible
CHRN Art. 55 MedDO Art. 55 MedDO
Swiss identification number
(for timelines see the section at the end
of the table)
6 Verification of the device Required Before placing on the market: formal Before making available on the market:
Check that declarations of conformity verification according to Formal verification according to
and TD have been drawn up and that Art. 53 para. 1 MedDO Art. 54 para. 1 MedDO
conformity assessment procedures
have been carried out (certificates) In the event of non-conformities, inform In the event of non-conformities, inform
Check the manufacturer's registration manufacturer and authorised manufacturer and, where applicable,
obligations regarding devices representative importer and authorised representative
Art. 11 para. 3 let. a and c MDR Art. 13 para. 2 MDR Art. 14 para. 2 MDR
7 Traceability of devices (see explanation Required Required Required
at the end of the table)
8 Storage and transport n.a. (not part of the supply chain) According to manufacturer's According to manufacturer's
instructions instructions
Art. 13 para. 5 MDR Art. 14 para. 3 MDR
9 Report serious incidents and safety Responsible for ensuring that the Not required Not required
corrective actions in Switzerland to reports are sent to Swissmedic
Swissmedic, trend reports Art. 66 para. 2bis MedDO
10 Immediate forwarding of complaints To manufacturer To manufacturer, if applicable to To manufacturer, if applicable to
and reports about suspected incidents Art. 11 para. 3 let. g MDR authorised representative importer and authorised representative
Art. 13 para. 8 MDR Art 14 para. 5 MDR

11 Register of complaints, non-conforming Access to technical documentation, Keep a "Complaints List" Keep a "Complaints List"
devices, recalls and withdrawals including data on post-market Art. 13 para. 6 MDR Art 14 para. 5 MDR
("Complaints List") surveillance, see row # 1 of the table.
Art. 11 para. 3 let. b MDR

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# Obligation CH-REP CH-importer CH-distributor
12 Cooperation within the supply chain on Not part of the supply chain, obligations Provide the manufacturer, authorised Keep the manufacturer and, where
the investigation of complaints are based on the written mandate with representative and distributors with any available, the authorised representative
the manufacturer. information requested by them so that and the importer updated about the
they can investigate complaints "Complaints List" and provide them
Art. 13 para. 6 MDR with any information upon their request
Art 14 para. 5 MDR
13 Corrective actions / Preventive actions Cooperation with Swissmedic in all Assist with the implementation of Assist with the implementation of
preventive or corrective actions corrective actions (including recalls) corrective actions (including recalls)
Art. 11 para. 3 let. f MDR Art. 13 para. 7 MDR Art 14 para. 4 MDR
14 Document retention requirements Keep available a copy of the TD, or Declarations of conformity and No requirements according to
contractually agree that the certificates therapeutic products legislation
manufacturer shall, on request, submit
the documentation directly to
Swissmedic within 7 days.
10 years (15 years for implantable
Declarations of conformity and devices) after the last device was
certificates. placed on the market
Art. 13 para. 9 MDR
10 years (15 years for implantable Art. 10 para. 8 MDR
devices) after the last device was
placed on the market
Art. 51 3bis MedDO
Art. 11 para. 3 let. b and 10 para. 8
MDR

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To section # 5 Registration of the economic operators / CHRN Swiss identification number 15:

Devices placed on CH-manufacturer or CH-REP CH-distributor

the market CH-importer
EO places product on the market for the first time after 26 May 2021: do not need to
Registration within 3 months. register
MDR devices
Subsequent registration for EOs that have placed devices on the market
for the first time before 26.05.2021: by 26.11.2021 16
EO places product on the market for the first time after 26 May 2021: do not need to
Only MDD/AIMDD Registration within 3 months. register
devices Subsequent reregistration for EOs that have placed devices on the market
for the first time before 26.05.2021: no obligation

To section # 7: Traceability of devices includes the following:

 EOs shall cooperate so as to achieve an appropriate level of traceability of devices (Art. 64
para. 1 MedDO).
 At the request of Swissmedic, EOs shall disclose the following: all EOs from whom they have
acquired a device, and all EOs, healthcare facilities and healthcare professionals to whom
they have supplied a device. This duty of disclosure continues for at least 10 years, or for at
least 15 years for implants, after the last product covered by the declaration of conformity was
placed on the market (Art. 47c TPA and Art. 64 para. 2 MedDO).
 EOs (and healthcare facilities) shall store and keep, preferably by electronic means, the UDI of
the class III implantable devices which they have supplied, or with which they have been
supplied (Art. 65 MedDO)

6 Indication of the manufacturer, CH-REP and importer

The manufacturer of the device must always, without exception, be defined and indicated on the label.

For imported devices, the CH-REP and the importer should be indicated according to the following
table.

Distributors are not obliged to indicate the address on the device or in a document accompanying the
device.

The details of the economic operators include the name and address of the registered place of
business.

15 Art. 55 MedDO, see www.swissmedic.ch > Medical devices > Market access > Unique identification number (CHRN) for
more information
16 Art. 104b MedDO

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Device CH-REP CH importer

Deadline: From 26.05.2021, if applicable after the deadlines stated in Deadline: From
section 4.2 of this information sheet 26.05.2021
Where: Where: On the device or
MDR devices Until 31.07.2023 either on the label or in a document accompanying on the packaging or in a
Class I the device 17. document accompanying
After 31.07.2023 the device

On the label

Deadline: From 26.05.2021, if applicable after the deadlines stated in

MDR devices section 4.2 of this information sheet
Class IIa, IIb or III Where: On the label

Deadline: After the deadlines stated in section 4.2 of this information Deadline: from 31 July
sheet. 2022 19
MDD/AIMDD
Where: Where: On the device or
devices
- MDD: On the label or in the instructions for use or in a document on the packaging or in a
with EU/EEA document accompanying
accompanying the device 18.
manufacturer or the device
- AIMDD: On the sales packaging and in the instructions for use or in
EC-REP
a document accompanying the device18.

MDD/AIMDD Deadline: From 26.05.2021

devices Where:
without EU/EEA - MDD: On the label or in the instructions for use
manufacturer or - AIMDD: On the sales packaging and in the instructions for use
without EC-REP

Legal framework for affixing the address

CH-REP and MDR devices: Art. 16 para. 1 MedDO in conjunction with Annex I point 23.2 (d) MDR
CH-REP and MDD/AIMDD devices: Art. 7 para. 1 let. a and b oMedDO in conjunction with Annex I
point 13.3 MDD and Annex I points 14.2 indent 1 and 15 indent 2 AIMDD
Importer: Art. 53 para. 2 MedDO

Deadline: The date of placing on the market is relevant (see definitions in section 3). Art. 101 para. 3
MedDO applies without prejudice.

Label: 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. 2 point 13 MDR).

17 The legal basis for the temporary, relaxed requirement to indicate the CH-Rep for Class I MDR devices shown in the table,

is to be created during the revision of the MedDO in connection with the entry into force of the IvDO. Until then, such
relaxations are applied within the scope of tolerance in enforcement of the law. Swissmedic reserves the right to modify the
information sheet as required in accordance with the subsequently approved ordinance text.
18 Given the non-uniform implementation among the EU member states with respect to legacy devices from Switzerland, and

to prevent potential supply shortfalls due to a mandatory affixation on the label of legacy devices, it is accepted – in analogy
to the importer information – to indicate this information in a document accompanying the device.
19 In version 1 of this information sheet, Swissmedic stated that it will provisionally (i.e. until the EU practice becomes known

or, if not specified by the EU, until 31 July 2022) not require the CH-importer to be stated on legacy devices. Since version 2
of this present information sheet, an interpretation of the term "accompanying document" that is different from the EU (see
MDCG 2021-27 of December 2021, question 8) has been adopted; hence, the subsequent procedure of the EU is no longer
relevant in this respect, although the tolerance period up to 31 July 2022 is retained.
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What does "in a document accompanying the device" mean?

The "document accompanying the device" can be affixed to the device or be separate from the
device. Examples of documents accompanying the device include: delivery note, guarantee
certificate, customs documents, invoice, a sticker on the packaging or the instructions for use.
Such documents must accompany the devices through the supply chain so that distributors are able
to fulfil their verification obligation stated in Art. 54 para. 1 let. d MedDO (indicating the importer).
Therefore, the "document accompanying the device" does not necessarily need to reach the end
user. The aim and purpose of the information is to allow rapid and unambiguous identification of the
economic operators responsible for the relevant devices (importer and, if applicable, CH-REP), e.g.
for implementing product recalls, reporting incidents, reporting dangerous devices or non-
conformities, and in the context of enforcement.

Note: This is the Swiss interpretation of the term "document accompanying the device", which differs
from the European interpretation (MDCG 2021-27 of December 2021, question 8) for supply-related
reasons.

7 Translation of product information and repackaging

The MedDO regulates the translation of the product information 20 and the repackaging of devices by
importers and distributors (Art. 53 para. 4 and Art. 54 para. 4 MedDO in conjunction with Art. 16
paras. 3 and 4 MDR). Accordingly, this is permitted under the specified conditions, e.g. if parallel
imported devices are adapted to the linguistic requirements applicable in Switzerland. Swissmedic
bases its interpretation of the applicable provisions on the European practice. Guidance published by
the European Commission can be found on this website
https://ec.europa.eu/health/md_sector/new_regulations/guidance.

Repackaged or relabelled devices must be notified to Swissmedic before they are placed on the
market by the importer or distributor established in Switzerland 21.

8 Frequently asked questions

Do authorised representatives, importers and distributors of devices need an authorization
from Swissmedic?
No, but authorised representatives and importers must register themselves ("CHRN").

What are the obligations of importers and distributors with respect to MDD/AIMDD devices
(legacy devices)?
Whereas Art. 53 and 54 MedDO apply without restrictions for MDR devices, for MDD/AIMDD devices
the obligations specified in Art. 53 and 54 MedDO should be considered in conjunction with the
transitional provisions as per Art. 101 para. 2 MedDO; these allow conforming MDD devices to be
placed on the market after 26 May 2021 even if the requirements of MDR are not completely met. The
following provisions of the MDR are applicable: post-market surveillance and market surveillance,
vigilance and registration of economic operators and of the devices 22.

What are the obligations of pharmacies, supermarkets, online shops and other dispensing
outlets?
They are considered to be importers with respect to devices received directly from another country
and which they place on the Swiss market.
As regards devices procured in Switzerland, the dispensing outlets assume the role of distributor.
In both cases, compliance with the corresponding obligations must be ensured.

20 Art. 16 para. 1 MedDO

21 www.swissmedic.ch > Medical devices > Market access
22 Art. 101 para. 2 MedDO
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Two companies import identical devices from another country (e.g. in connection with a
parallel import) and place these on the market in Switzerland. Which of the two companies is
the importer?
Both companies assume the role of importer (see definitions of importer and placing on the market,
sections 2.3 and 3), i.e. both companies must comply with the corresponding obligations.

A company imports a device from a manufacturer in another country and places this on the
market in Switzerland. The same company is mandated as a CH-REP by the manufacturer.
What are the company's obligations?
The company is subject to the obligations of both the CH-REP and importer. The companymust
register both as an importer and CH-REP and receives two CHRN.

The disclosure requirements stated in Art. 47c TPA require economic operators to disclose the
following to Swissmedic on request: a. all economic operators from whom they have acquired
a medical device; b. all economic operators to whom they have supplied a medical device; and
c. all healthcare facilities or healthcare professionals to whom they have supplied a medical
device. In concrete terms, what does this mean for data recording? What data am I, as an
economic operator, obliged to record and keep?
In order to satisfy the disclosure requirements, an economic operator must record the devices that it
has acquired and forwarded (source of supply and recipient of the devices, quantities, lot and serial
numbers, dates of deliveries). The data must be stored such that the economic operator can provide
the information stated in Art. 47c TPA without great effort (i.e. at very short notice if necessary) (e.g.
in connection with the administrative surveillance of field safety corrective actions or market
surveillance procedures).
The duty of disclosure does not require each individual device to be traced (exception: class III
implantable devices, see Art. 65 MedDO).

I would like to sell devices as a private person, e.g. via an online platform. What must I bear in
mind?
As a private person you are subject to the same obligations as any other importer or distributor.

As a healthcare facility, we dispense patients devices used for their treatment (e.g. dressing
material for changing at home, support stockings, stoma bags). So are we importers /
distributors?
The answer depends on the individual case. If the situation involves putting into service associated
with use/treatment (Art. 4 para. 1 let. c MedDO), the obligations for users/final users apply. On the
other hand, if a trading activity exists (Art. 4 para. 1 let. i MedDO) and this has no direct relationship
with the treatment/use, the obligations of the distributor (or the importer in the case of an import) must
be observed. In the case of a direct import from another country associated with direct use in
Switzerland, Art. 70 MedDO should also be observed, and the user assumes responsibility for the
conformity of the device.

9 Further information
Information on registration, CHRN, UDI, and FAQ on various MDR issues can be found at
www.swissmedic.ch > Medical devices.

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 Information sheet
Obligations Economic Operators CH

Change history
Version Valid and Description, comments (by author) Author’s
binding from initials
2.0 30.12.2021 Updating of section 6 mea
1.0 23.11.2021 New doc ID, no content changes. Old doc ID: MU603_00_017 mea
(version 1.0 dated 10.08.2021)

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Swissmedic • Hallerstrasse 7 • 3012 Berne • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12