Since Switzerland is now classified as a so-called "third country", a Swiss Authorised Representative "SWISSREP" is required.
From May 26, 2021, the usual European-Swiss market access for medical devices is no longer guaranteed.
Reason: The European Commission had made the continuation of the usual market access dependent on the so-called institutional framework agreement, which was not signed.
As a result, European medical device manufacturers who do not have a branch in Switzerland now have to name an „Authorised Swiss Representative“ in Switzerland who represents the manufacturer to the Swiss authorities.
See deadlines. The authorised representative represents the foreign manufacturer and is responsible for product safety, he is liable for product defects like the manufacturer.
Swissmedic: “If the manufacturer of a medical device is not based in Switzerland, his products may only be placed on the market after an authorised representative based in Switzerland has been mandated (Art. 51 Para. 1 MepV). This also applies to manufacturers based in the European Union. "
The Swiss authorised agent for medical devices - SWISSREP - corresponds to the European agent. In both cases, the ordering of the conclusion requires a written agreement (“mandate”).
The authorised representative is the contact person for the Swiss authorities and assumes the responsibility of the manufacturer. The authorised representative can be a legal person or a natural person and must have access to at least one person with the necessary regulatory expertise.
It is therefore advisable to choose an established Swiss consulting company in the field of medical device regulatory / QM as SWISSREP from the outset. The SWISSREP has obligations like the manufacturer, this is particularly relevant in terms of liability law.
According to the Product Liability Act, the manufacturer is liable for any product defects. The Swiss Medical Devices Ordinance extends this liability to the Swiss authorised representative. Thus, the authorised representative is jointly and severally liable with the manufacturer for any product defects. The authorised representative's liability for product defects is mandatory by law and cannot be limited or waived by contract. However, contractual exemption clauses can be agreed in the contract between the manufacturer and the authorised representative. For example, the manufacturer can undertake to exempt the authorised representative from claims by third parties, provided that the authorised representative is not at fault.
The manufacturer's responsibilities are largely regulated by law. The focus of product stewardship is the manufacturer. He must prove and document the conformity of his product including the correct product classification. He is also responsible for the introduction and maintenance of a quality management system.
The manufacturer must meet his obligations and keep the documents up to date. The authorised representative's responsibility is limited to checking the measures taken by the manufacturer with regard to the statutory provisions in Switzerland. Due to the far-reaching legal consequences of non-compliance, the manufacturer is contractually obliged to guarantee that the authorised representative fully complies with his legal obligations. This also applies to the affixing of the CE mark, the allocation of a Unique Device Identification (UDI) number, the correct instructions for use including their translation into the required languages in Switzerland.
Storage obligation
The storage and other obligations must be contractually regulated: Manufacturer - 15 years.
Obligation to report
The authorised representative, like the manufacturer, is legally obliged to report certain facts to the authorities and to hand over documents on request. These modalities, like the NDA, are contractually agreed in detail and client-specific.
Liability insurance
In order to guarantee liability claims, the manufacturer and the authorised representative are obliged to take out liability insurance with sufficient coverage. This obligation cannot be contractually waived, but the manufacturer can undertake to assume the insurance costs for the authorised representative.
In accordance with the importance of his function for patient protection, the authorised representative - SWISSREP - must first be clear about his task and the product properties. The authorised representative must perform due diligence before accepting his mandate or signing the contract with the manufacturer. This means checking the technical documentation.
Product liability of the SWISSREP
Although the authorised representative has not developed the product as soon as he represents the foreign manufacturer as SWISSREP, he is responsible for product safety and is liable for product defects like the manufacturer.
Importers / wholesalers / online retailers are also liable.
The full medical device liability also applies to importers who take on the SWISSREP function, because this means that they are fully covered by product liability, as if they were the manufacturer of the medical device themselves. Online retailers are also affected: See point 11.
Deadlines
December 31, 2021: Class IIb and III
March 31, 2022: Class IIb and IIa
July 31, 2022: Class I
July 31, 2022: Systems and treatment units
The deadline means that the papers for the SWISSREP must be complete and compliant by then, this can sometimes take time. Advice: start in good time months in advance, just to be on the safe side.
Swissmedic:
Art. 104a98 Appointment of authorised representatives
If the manufacturer is domiciled in an EU or EEA state, or if the manufacturer has designated an authorised representative domiciled in an EU or EEA state, that manufacturer must designate an authorised representative in accordance with Article 51 paragraph 1 within the following time periods:
a. for class III devices, class IIb implantable devices and active implantable devices: by 31 December 2021;
b. for non-implantable class IIb devices and class IIa devices: by 31 March 2022;
c. for class I devices: by 31 July 2022.
(2 For systems and procedure packs, an authorised representative in accordance with Article 51 paragraph 5 must be appointed by 31 July 2022.
98 Inserted by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281).)
Choose an established and competent medical device / regulatory Swiss company that will take on the task of the SWISS-REP for you.
The regulation of the Swiss agent corresponds to that of the European agent. A written agreement (“mandate”) is required in each case.
Receive your non-binding offer here.
Swissmedic:
any natural or legal person established in Switzerland who is instructed in writing by a manufacturer domiciled abroad to perform certain tasks on his behalf in fulfilling the manufacturer's obligations arising from this ordinance;
Swissmedic:
Section 2 Authorised Representative
Art. 51 Obligations
1 Where the manufacturer of a device is not domiciled in Switzerland, the device may only be placed on the market if the manufacturer designates an authorised representative domiciled in Switzerland by means of a written mandate.
2 The authorised representative is responsible for the formal and safety-related aspects of placing the device on the market.
3 The authorised representative’s rights and obligations and the scope of its mandate are governed by Article 11 EU-MDR63.
3bis The manufacturer and authorised representative may contractually agree that instead of the authorised representative keeping available a copy of the technical documentation, the manufacturer shall, on request, submit the documentation straight to Swissmedic. The authorised representative must ensure that the documentation is submitted within seven days.64
4 Changes in authorised representative are governed by Article 12 EU-MDR.
5 Paragraphs 1–4 also apply to natural or legal persons who assemble systems and procedure packs in accordance with Article 22 paragraphs 1 and 3 EU-MDR and who are not domiciled in Switzerland.65
63 See the footnote to Art. 4 para. 1 let. f.
64 Inserted by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281)
65 Inserted by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281)
Art. 52 Person responsible for regulatory compliance
1 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 under this Ordinance and who is responsible for regulatory compliance.
2 In other respects, Article 49 paragraphs 2–4 shall apply.
Quality management system
Risk management
Systems for monitoring after the placing on the market
clinical trials, the clinical evaluation, case study
clinical follow-up observation after the placing on the market
The competent SWISSREP company checks your documents beforehand so that you have security during controls.
Request offer
Phone: 0041(0)763710977
Swissmedic:
Chapter 2 Making available on the Market and Putting into Service
Section 1 Requirements
Art. 6 General safety and performance requirements
1 A device may be placed on the market or put into service only if it complies with this Ordinance when duly supplied and properly installed, maintained and used in accordance with its intended purpose.
2 Devices must conform to the general safety and performance requirements set out in Annex I to EU-MDR10, taking account of their intended purpose.
3 Appropriate evidence that the part of the combination that is deemed to be a device under the cases set out in Article 2 letters f–h fulfills the product requirements must be presented to the competent authority on demand.
4 Compliance with the essential requirements of this Ordinance, as covered by designated technical standards11, common specifications or prescriptions of the pharmacopoeia12, is presumed if the device is in conformity with these standards, specifications or prescriptions.
5 The presumption made in paragraph 4 also applies to compliance with the system or process requirements that economic operators must comply with under this Ordinance, including requirements associated with quality management systems, risk management, post-market surveillance systems, clinical trials, clinical evaluation or post-market clinical follow-up.
6 Compliance with the common specifications in paragraph 4 is required unless the manufacturer can provide appropriate proof that the solutions it has chosen guarantee equivalent conformity with the safety and performance requirements. The above is subject to Article 8 paragraph 1.
10 See the footnote to Art. 4 para. 1 let. f.
11 The electrical standards can be obtained from the industry association Electrosuisse, Luppmenstrasse 1, 8320 Fehraltorf, www.electrosuisse.ch; the remaining standards can be obtained from the Swiss Association for Standardization (SNV), Sulzerallee 70, 8404 Winterthur, www.snv.ch.
12 SR 812.211
Provision on the market and commissioning
Swissmedic:
Art. 7 Distance sales
1 Devices marketed by means of information society services – specifically an online service – that fulfil the conditions set out in paragraph 4 must comply with this Ordinance.
2 Similarly, devices that are not placed on the market but are used in the context of a commercial activity, whether in return for payment or free of charge, for the provision of a diagnostic or therapeutic service offered by means of information society services or by other means of communication must also comply with this Ordinance.
3 Upon request by the Swiss Agency for Therapeutic Products (Swissmedic), any natural or legal person offering a device in accordance with paragraph 2 or providing a service must be able make available a copy of the declaration of conformity.
4 A device is deemed to be supplied via an information society service if that service:
a. is provided by distance selling, specifically without the contracting parties being physically present at the same time;
b. is provided electronically; and
c. is provided at the individual request of the recipient or the recipient’s representative.
5 To protect public health, Swissmedic may require a provider of information society services to discontinue its activities in Switzerland.
Swissmedic:
Art. 8 Specific requirements
1 Devices without an intended medical purpose in accordance with Article 1 paragraph 1 letter b must comply with the common specifications stipulated by Swissmedic.
2 Devices that have both a medical and non-medical intended purpose must fulfil both the requirements for devices with a medical intended purpose and the requirements for devices without an intended medical purpose.
3 Devices that are also machines within the meaning of Article 1 of the Machine Ordinance of 2 April 200813 must satisfy the pertinent general safety and health protection requirements of the Machine Ordinance where these requirements are more specific than those of Chapter II of Annex I to EU-MDR14.
13 SR 819.14
14 See the footnote to Art. 4 para. 1 let. f.
Swissmedic:
Art. 47 Technical documentation
1 Manufacturers must list in the technical documentation the information required in Annexes II and III to EU-MDR59, taking account of the amendments to these Annexes made by the European Commission by means of delegated acts60.
2 Manufacturers must submit either the complete technical documentation or a summary of this documentation when requested to do so by the competent authority.
59 See the footnote to Art. 4 para. 1 let. f.
60 See Annex 4.
Art. 50 Further obligations
The further obligations incumbent on manufacturers, particularly the requirements to be fulfilled by their quality and risk management systems, are governed by Article 10 EU-MDR62.
62 See the footnote to Art. 4 para. 1 let. f.
Swissmedic:
Chapter 3: Conformity assessment, certification and declaration
Section 1 Conformity assessment
Art. 21 Principle
1 Any natural or legal person who is domiciled in Switzerland and makes devices available on the market in Switzerland or in a contracting state must, upon request, provide the authorities responsible for controls as part of market monitoring with the declaration of conformity.
2 Any natural or legal person who is domiciled in Switzerland and places a device on the market in Switzerland or in a contracting state or puts a device into service in Switzerland or in a contracting state without placing it on the market must carry out and be able to produce documentary evidence of an evaluation of the device’s conformity with the general safety and performance requirements.
3 The demonstration of compliance with the general safety and performance requirements must also include a clinical evaluation in accordance with Article 61 EU-MDR35.
35 See the footnote to Art. 4 para. 1 let. f.
Swissmedic:
Art. 38 Duty of cooperation and notification requirement
1 The designated bodies, including their subsidiaries and sub-contractors, are required to keep available for Swissmedic at all times all data that is necessary for assessment, designation, monitoring and re-assessment, including the documents required to assess the qualifications of sub-contractors or subsidiaries. The data must be kept up-to-date at all times.
2 The designated bodies shall notify Swissmedic within 15 days of any change that affects their ability to meet the requirements of Annex VII to EU-MDR54 or to carry out conformity assessments.
54 See the footnote to Art. 4 para. 1 let. f.
Swissmedic:
Chapter 6 Requirements for Economic Operators
Section 1 Manufacturers
Art. 46 Conformity marking and clinical evaluation
1 Manufacturers guarantee that their products have been designed and manufactured in accordance with the requirements of this Ordinance when they place them on the market or put them into service.
2 They must print the conformity marking on their products.
3 They must conduct a clinical evaluation in accordance with Article 61 EU-MDR57 taking account of the amendments to this Article adopted by the European Commission by means of delegated acts58 and in accordance with Annex XIV to EU-MDR. They must update this clinical evaluation in line with the results of post-market clinical follow-up.
57 See the footnote to Art. 4 para. 1 let. f.
58 See Annex 4.
Section 4 Distributors
Art. 54
1 When making a device available on the market, distributors must, in the context of their activities, act with due care in relation to the requirements applicable. Before making a device available on the market, distributors must verify that:
a. the device carries the conformity marking;
b. the declaration of conformity has been drawn up;
c. the device is accompanied by product information;
d. where devices have been imported the importer has provided the information required in Article 53 paragraph 2;
e. the manufacturer has assigned a UDI where applicable.
2 With the exception of paragraph 1 letter d, random sampling may be used for the purposes of verification.
3 Where a distributor considers or has reason to believe that a device is not in conformity with the requirements of this Ordinance, it must not make the device available on the market until it has been brought into conformity.
4 The further obligations of distributors prior to and after making a device available on the market are governed by Articles 14 and 16 paragraphs 3 and 4 EU-MDR67. In particular, distributors must fulfil the following obligations:
a. storage, transport and quality management system;
b. cooperation with the manufacturer, authorised representative, importer and competent authorities;
c. the provision of information to the manufacturer, authorised representative, importer and competent authorities.
67 See the footnote to Art. 4 para. 1 let. f.
Swissmedic:
any natural or legal person established in Switzerland who places a product from abroad on the Swiss market;
Section 3 Importers
Art. 53
1 Importers may only place on the market devices that comply with this Ordinance. Before placing devices on the market, they shall verify that:
a. the device carries the conformity marking;
b. the declaration of conformity has been drawn up;
c. the manufacturer is identified and has designated an authorised representative in accordance with Article 51;
d. the product is labelled in accordance with this Ordinance and accompanied by instructions for use;
e. the manufacturer has assigned a UDI where applicable.
2 Importers must print their name, place of business and contact address on the product, the product packaging or a document enclosed with the product.
3 Where an importer considers or has reason to believe that a device is not in conformity with the requirements of this Ordinance, it must not place the device on the market until it has been brought into conformity.
4 The further obligations of importers prior to and after placing a device on the market are governed by Articles 13 and 16 paragraphs 3 and 4 EU-MDR66. In particular, importers must comply with the following obligations:
a. storage, transport and quality management system;
b. cooperation with the manufacturer, authorised representative, designated body and competent authorities;
c. the provision of information to the manufacturer, authorised representative, designated body and competent authorities.
66 See the footnote to Art. 4 para. 1 let. f.
Swissmedic:
any natural or legal person who manufactures a product or reprocesses or has it developed, manufactured or reprocessed and markets this product under their own name or brand; The specifications and exceptions listed in Article 16 Paragraphs 1 and 2 of Regulation (EU) 2017/7457 on Medical Devices (EU MDR) are reserved;
Swissmedic:
Legal manufacturer, authorised representative, importer, dealer and the person in accordance with Article 22 paragraphs 1 and 3 of the EU MDR;
Section 568 Registration of Economic Operators
68 Amended by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281).
Art. 55
1 Manufacturers or their authorised representatives and importers must register the information required by part A of Annex VI to EU-MDR69 with Swissmedic within three months of placing a device on the market for the first time.
2 The economic operator in question must report any changes to the information to Swissmedic within one week.
3 Further obligations and registration modalities are governed by Articles 30 paragraph 3 and 31 EU-MDR.
4 Swissmedic will verify the information provided by the economic operators and assign them a unique identification number.
5 Any natural or legal person placing systems and procedure packs on the market for the first time under Article 11 must register their name and the address at which they can be contacted with Swissmedic within three months of placing the system or procedure pack on the market. Where an authorised representative is required under Article 51 paragraph 5, the name and address of the authorised representative must also be registered with Swissmedic.
69 See the footnote to Art. 4 para. 1 let. f.
Swissmedic:
Time at which a ready-to-use product, with the exception of test products, is made available to end users for use on the Swiss market in accordance with its intended purpose for the first time.
Swissmedic:
first-time provision of a product on the Swiss market, with the exception of test products.
Swissmedic:
any transfer or provision of a product, whether in return for payment or free of charge, with the exception of test products, for distribution, consumption or use on the Swiss market as part of a commercial activity;
Section 568 Registration of Economic Operators
68 Amended by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281).
Art. 55
1 Manufacturers or their authorised representatives and importers must register the information required by part A of Annex VI to EU-MDR69 with Swissmedic within three months of placing a device on the market for the first time.
2 The economic operator in question must report any changes to the information to Swissmedic within one week.
3 Further obligations and registration modalities are governed by Articles 30 paragraph 3 and 31 EU-MDR.
4 Swissmedic will verify the information provided by the economic operators and assign them a unique identification number.
5 Any natural or legal person placing systems and procedure packs on the market for the first time under Article 11 must register their name and the address at which they can be contacted with Swissmedic within three months of placing the system or procedure pack on the market. Where an authorised representative is required under Article 51 paragraph 5, the name and address of the authorised representative must also be registered with Swissmedic.
69 See the footnote to Art. 4 para. 1 let. f.
Swissmedic:
Section 2 Definitions and References to European Legislation
Art. 3 Medical device and accessories
1 Medical devices are instruments, apparatus, appliances, software, implants, reagents, materials or other objects:
a. that are intended by their manufacturer for use in human beings;
b. that do not achieve their principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which action can be assisted by such means; and
c. that serve to fulfil one or more of the following specific medical purposes either alone or in combination:
1. diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
2. diagnosis, monitoring, treatment, alleviation or compensation of injuries or handicaps,
3. investigation, replacement or modification of the anatomy or of a physiological or pathological process or condition,
4. acquisition of information by means of in vitro investigation of samples obtained from the human body, including donated organs, blood or tissue.
2 Medical devices also include:
a. contraceptive or fertility-enhancing products;
b. items intended specifically to clean, disinfect or sterilise the devices listed in Article 1, paragraph 1 and in paragraph 1 of this Article.
3 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 and:
a. which makes it possible to use the medical device or devices in accordance with its or their intended purpose; or
b. which specifically and directly supports the medical function of the medical device or devices in line with its or their intended purpose.
Swissmedic:
Art. 2 Exceptions
1 This Ordinance does not apply to:
a. human blood, blood products, plasma or blood cells of human origin, or devices which, when placed on the market or put into service, incorporate such blood products, plasma or cells with the exception of the devices specified in Article 1 paragraph 3 letter a;
b. vital organs, tissues or cells and transplant products of human origin;
c.vital organs, tissues or cells and transplant products of animal origin;
d. any items other than those listed in letters a–c that are composed of or contain viable biological substances or viable organisms, including living micro-organisms, bacteria, fungi or viruses, in order to achieve or support the intended purpose of the device;
e. in vitro diagnostic medical devices; these are subject to Articles 105 and 107;
f. non-separable combinations of a medicinal product and device intended to deliver a medicinal product that are intended solely for use in this combination and are not reusable;
g. combinations which, when placed on the market or put into service, incorporate as an integral part a medicinal product in addition to the device, where the medicinal product assumes a primary function in such combinations;
h. combinations which, when placed on the market or put into service, incorporate as an integral part non-viable tissue or non-viable cells of human origin or their derivatives in addition to the device, where such tissue, cells or derivatives assume a primary function in the device;
i. medical devices intended solely for use in animals or veterinary diagnostics.
2 In the cases specified in paragraph 1 letters f–h, the part of the combination that fulfills the role of device must satisfy the general safety and performance requirements set out in Article 6.
Swissmedic:
Art. 19 Reporting obligation for natural and legal persons who make custom-made devices available on the market
1 Any natural or legal person who makes custom-made devices available on the Swiss market must provide the following information to Swissmedic before making the devices available:
a. the name and address of the manufacturer and all manufacturing sites;
b. the name and address of the authorised representative if applicable;
c. the codes required to identify the relevant product categories, as specified by the European Commission by means of implementing acts32.
2 Changes to this information must be reported to Swissmedic within 30 days of the changes taking effect.
3 Depending on the risk inherent in a device and its use, Swissmedic may exempt custom-made devices from the reporting obligation under paragraph 1.
32 See Annex 4.
Chapter 7 Device Surveillance
Section 1 Post-market Surveillance
Art. 56 System
1 For each device, manufacturers must plan, establish, document, implement, maintain and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device. This system forms an integral part of the manufacturer's quality management system.
2 The system must be suited to actively and systematically gathering, recording and analysing relevant data on the quality, performance and safety of a device throughout its entire lifetime, and to drawing the necessary conclusions and to determining, implementing and monitoring any preventive and corrective actions.
3 The modalities of the system, particularly the resulting actions, updates and amendments to technical documentation, are governed by Article 83 paragraph 3 EU-MDR70.
70 See the footnote to Art. 4 para. 1 let. f.
Art. 57 Incidents and actions
1 Should it become evident in the course of post-market surveillance that preventive and/or corrective action is necessary, manufacturers must take suitable steps, notifying the competent authorities and, if applicable, the designated body.
2 If a manufacturer becomes aware of a serious incident in connection with a device that has been made available on the market, or takes action to prevent or minimise the risk of such an incident for medical or technical reasons (field safety corrective actions), it must report the fact in accordance with Article 66.
Art. 58 Plan
The post-market surveillance plan must satisfy the requirements of Section 1 of Annex III to EU-MDR71. With the exception of custom-made devices, the plan is part of the technical documentation specified in Annex II to EU-MDR.
71 See the footnote to Art. 4 para. 1 let. f.
Art. 59 Report
1 Manufacturers of class I devices must draw up a report on post-market surveillance.
2 This report must contain:
a. a summary of the results and conclusions of the analyses of the data gathered as a result of the plan specified in Article 58;
b. a rationale and description of any preventive and corrective actions taken.
3 The report forms part of the post-market surveillance technical documentation specified in Annex III to EU-MDR72.
4 The manufacturer must update the report when necessary and make it available to the competent authority upon request.
72 See the footnote to Art. 4 para. 1 let. f.
Section 2 Safety Report
Art. 60 Obligation
1 Manufacturers of class IIa, class IIb and class III devices shall prepare a safety report for each device and where relevant for each category or group of devices.
2 Manufacturers of class IIa devices shall update the safety report when necessary and at least every two years. Manufacturers of class IIb and class III devices must update this report at least annually.
Art. 61 Content
1 The safety report must contain:
a. a summary of the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan as specified in Article 58;
b. a rationale and description of any preventive and corrective actions taken.
2 Throughout the lifetime of the device concerned, the safety report must set out:
a. the conclusions of the benefit-risk determination;
b. the key results of post-market clinical follow-up;
c. the total sales volume of the device;
d. an estimate of the size of the population using the device;
e. characteristics of the population in letter d;
f. the frequency of device usage, where practicable.
3 The safety report forms part of the technical documentation specified in Annexes II and III to EU-MDR73. For custom-made devices, the report forms part of the documentation specified in Section 2 of Annex XIII to EU-MDR.
73 See the footnote to Art. 4 para. 1 let. f.
Art. 6274 Review
1 Manufacturers will make their safety reports available to the designated body involved in the conformity assessment.
2 The designated body will review the safety report for class III devices or implantable devices and record the outcome of its review with details of any action taken.
3 Manufacturers or their authorised representatives will, upon request, make the safety report and the outcome of the designated body’s review, with details of any action taken, available to the competent authority.
74 Amended by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281).
Section 3 Summary of Safety and Clinical Performance
Art. 63
1 For class III devices and for implantable devices, other than custom-made or investigational devices, the manufacturer must draw up a summary of safety and clinical performance.
2 The summary of safety and clinical performance shall be written in a way that is clear to the intended user and, if relevant, to the patient.
3 The minimum content of the summary is governed by Article 32, Paragraph 32 EU-MDR75.
4 The draft summary of safety and clinical performance must be submitted to the designated body involved in the conformity assessment pursuant to Article 24 for validation by that body.
5 The manufacturer will publish the summary after it has been validated.76
6 The manufacturer must mention on the label or instructions for use where the summary is available.
75 See the footnote to Art. 4 para. 1 let. f.
76 Amended by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281).
Section 4 Traceability and Recording of Product Identification
Art. 64 Traceability
1 Distributors and importers shall co-operate with manufacturers or authorised representatives to achieve an appropriate level of traceability of devices.
2 The duty of disclosure under Article 47c TPA continues for at least 10 years, or for at least 15 years for implantable products, after the last product covered by the conformity assessment was placed on the market.
Art. 65 Recording the UDI
1 Economic operators 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.
2 Swissmedic may extend this obligation to other devices, or categories or groups of devices.
Section 5 Vigilance
Art. 66 Reporting obligation
1 Manufacturers of devices made available in Switzerland or natural or legal persons who assemble systems or procedure packs in accordance with Article 22 paragraphs 1 and 3 EU-MDR77 must report to Swissmedic:
a. any serious incidents involving the device in question that have occurred in Switzerland, as soon as they become aware of them;
b. any field safety corrective actions undertaken in Switzerland.78
2 Exemptions from this reporting obligation, modalities, periodic summary reports, trend reporting and analyses of serious incidents and field safety corrective action are governed by Articles 27 paragraph 5 and 87–89 EU-MDR.
2bis Where an authorised representative is required pursuant to Article 51, this representative is responsible for the reporting obligation in paragraph 1. Furthermore, the authorised representative must submit the trend reports pursuant to paragraph 2 on incidents in Switzerland and abroad to Swissmedic without being requested to do so. Final reports prepared in accordance with Article 89 paragraph 5 EU-MDR should be submitted to Swissmedic. The transfer of these obligations from the manufacturer or from the natural or legal person assembling systems or procedure packs under Article 22 paragraphs 1 and 3 EU-MDR to the authorised representative must be agreed in writing in the mandate.79
3 ...80
4 Any professional who becomes aware of an incident when using devices must report this to the supplier and Swissmedic. The report may be submitted by a professional association. The timelines for doing so are as set out in Article 87 EU-MDR.
5 Reports must be submitted to Swissmedic electronically and in machine-readable format. Swissmedic publishes information on electronic submission and the forms to be used with content specifications.
77 See the footnote to Art. 4 para. 1 let. f.
78 Amended by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281).
79 Inserted by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281)
80 Repealed by No I of the O of 19 May 2021, with effect from 26 May 2021 (AS 2021 281).
Art. 67 Reporting systems in hospitals
1 Hospitals must set up an internal reporting system within the framework of an established quality management system for the purpose of reporting under Article 66 paragraph 4.
2 They must designate a suitable competent person (vigilance contact person) with a medical or technical qualification to assume responsibility for reporting to Swissmedic. They must supply this person’s contact details to Swissmedic.
3 Records and all documents created under the vigilance quality management system must be retained for at least 15 years.
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