SMART SOLUTIONS FOR THE MEDICAL INDUSTRY

WE REALIZE YOUR PRODUCT

YOUR PARTNER FOR MEDICAL AND INDUSTRIAL SOLUTIONS

BENEFIT FROM OUR MEDICAL DEVICE EXPERIENCE

Medical Device Regulation (MDR)

Swiss Authorized Representative

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SMART SOLUTIONS FOR THE MEDICAL INDUSTRY

BENEFIT FROM OUR MEDICAL DEVICE EXPERIENCE

WE REALIZE YOUR PRODUCT

YOUR PARTNER FOR MEDICAL AND INDUSTRIAL SOLUTIONS

Medical Device Regulation (MDR)

Swiss Authorized Representative

Scroll down

WE STAND FOR THE HIGHEST PRECISION AND A RELIABLE PARTNERSHIP

epmodex is your leading partner for the development, certification and market introduction of medical- and industrial products in high-end applications.

Our success is based on the fact that with our know-how we can bring new, innovative medical products more rapidly and successfully to the market.

Today, short time-to-market times are particularly important since the market is very competitive and these projects are primarily capital driven.

Whether a product receives approval one year sooner or later is critical! In this way we provide our customers with important strategic and competitive advantages.

Call us and benefit from our valuable experience.

Call us +41 (0) 44 200 11 00

EPMODEX IMAGE BROCHURE

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OUR SERVICES

Product Design & Development

epmodex is your engineering and development provider. Whether you have an idea, a specification, a concept or even a proven design already our engineers develop your needs into a market-ready product while keeping all of your requirements in mind. This ensures a straightforward market introduction without dealing with any compliance risks.

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Product Authorization

Thanks to our established risk management process according to ISO-14971 we do manage risks and define smart mitigation actions during the development process. With this systematic approach, we avoid unexpected surprises and ensure full visibility and surveillance throughout the entire product life cycle of your new medical device.
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System Realization

epmodex is your systems realization partner. We offer precisely interlinked and modular services for complex products associated with very small error tolerances, high standards of documentation and very detailed change management – all in accordance with ISO- 9001 and ISO- 13485.
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YOUR RELIABLE PARTNER

epmodex is specialized in the development and certification of systems and advanced assemblies with highest requirements on reliability and safety of the products.

Whenever you demand excellent behaviour from your products you can only rely on the best! With us as your partner you profit from fast time-to-market deliveries, the highest precision, low compliance risks, optimal solutions and a reliable partnership. Even for ambitious and complex challenges, we deliver with highly proficient specialists, smart solutions and high-tech manufacturing equipment.

As a one-stop shop!

Thanks to our many years of experience in medical products and other demanding industries our products meet the highest tolerance levels and perform even in the harshest of environments where other parts fail. To provide our clients with the best solutions, we work hand-in-hand with our carefully selected production partners in order to meet the standards of the European and American markets.

It is our mission to continue the development of technologies and processes. By our strong collaboration with the industry and science we use the most up-to-date technical practices and standards. Our clients know that we fully adhere to their industrial standards and that we stand for personalized assistance, fast response times, on time delivery, high flexibility and by every means the most economical solution.

OUR SPECIALISTS

You are in good hands with our specialists with many years of experience

Martin Epper, Dipl. Ing. FH

Managing Director / Owner

As a mechanical engineer with specialization in biomechanics and production techniques I support companies in the development, certification and market introduction of medical devices. When I founded epmodex in 2009 my motivation was to help companies to expedite time-to-market project lead times while keeping the safety standards of their new products very high. Today, I'm leading projects while keeping product requirements, safety aspects and deadlines in a holistic approach in mind.

Fabienne Di Gennaro- Speciale, PhD

Regulatory and Quality

With my several years of experience in the field of regulatory affairs, I've been giving support in the development of diverse medical devices in small and large companies for the main markets. As a professional biologist (PhD in Biology) I'm involved in several tasks at epmodex, such as regulatory/quality, development support, road-mapping, verification/validation activities and biologics.

Isa Epper

Customer Service / Member of the Board

As a professional in organizational topics I’m in charge of epmodex’s accounting, marketing activities, customer relations, logistics and support in quality assurance activities. I like the variety and daily challenges of my job and using my skills I do support the team where help is needed.

Petros Nianias

Product Development

My special skills are to find the best geometry and shape to fulfill all specific product requirements. Always considering the best risk-benefit approach. Further, it’s my passion to transfer a product prototype into a ready-for-serie product to allow a smooth production transfer. Using my expertise, I can optimize the product assemblies to any requested quantity and quality.

Christian Dillier

Sales

My passion is to bring new innovative products to the market. Since my apprenticeship I have been working in industry- and medical technology. In my former profession as a polymechanic, I’ve had the opportunity to get to know many different industries and manufacturing processes during my career. During my training as a technician for business processes, I learned to apply methods in practice to design processes efficiently. Today, it’s a great pleasure for me to apply the collected know-how in sales every day.

Christoph Teichler, Dipl. Ing. ETH

Product Development and Consulting

Being a mechanical engineer by training, I have worked in medical device companies in Europe and Asia for the last 15 years. I started in product development and branched out into product marketing and sales. With my several years of experience I can provide guidance on product registration and marketing strategy with a pragmatic and industrious approach.

PRODUCT DESIGN & DEVELOPMENT

Straight forward development at your finger tips

epmodex is your design- and development specialist. Our wealth of experience in a diverse array of demanding industry applications enables us to integrate a wide range of technologies quickly, competently and economically. Using a combination of creative and systematic methods, we offer you tremendous innovation along with optimum process reliability and very high standards of documentation.

Our services:

Patent research and -Application
Product development
Industrialization, Design- Transfer
Systems engineering
Product life cycle management
Assembling- and manufacturing technology
Product risk management according to ISO 14971:2012
Quality engineering
Verification-, validation-, qualification activities
MDR- remediation
UDI & Traceability
Product labelling & Packaging
Product regulation according to EU Medical Device Directive 93/42 EWG/ Medical Device Regulation 2017/745 and US FDA 21CFR820

We provide expertise in the following medical markets:

Dental
Traumatology
Orthopaedics
Spine
Surgical innovative instruments
Combination products

PRODUCT AUTHORIZATION

Medical device regulation (MDR)

In the name of product safety

Since May 26th 2021, the Medical Device Regulation is fully applicable. Hence, all processes related to design, industrialization, manufacturing, marketing and market surveillance have to be aligned with the quality management system which must be compatible with ISO 13485:2016 and/or USA QSR.

We help you to get there - Due to our top-level expertise and a wealth of experience we advise and support our global customers in updating and correcting their technical documentation. With this service, we ensure to successfully accelerate procedures along the entire life cycle of medical devices to keep the products safe. Our clients know that we fully adhere to their industrial standards and that we stand for personal assistance, fast response times, on-time delivery and the highest level of flexibility.

Keen to see how you get your products MDR compliant in 7 steps?

CLICK HERE

MDR - Outsource and focus on your strengths

The new Medical Device Regulation is now reality and a major and significant challenge for most medical technology manufacturers. As if the stricter regulations were not difficult enough, they come at a time when manufacturers are struggling to defend their position in a highly competitive market and are being forced to shorter innovation cycles.

If you want to see how you convert the challenges into a unique chance, download our whitepaper!

CLICK HERE

EPMODEX AS YOUR NEW SWISS AUTHORIZED REPRESENTATIVE (SWISS AR)

With the termination of the negotiations of the Federal Council with the European Union (EU) on the Institutional Agreement (InstA) on May 26, 2021, the temporary Medical Device Ordinance (MedDO) has been automatically installed. With respect to a transition period (depending device classification) all EU manufacturers will have to comply with specific Swiss requirements per temporary Medical Device Ordinance soon. This includes the appointment of a Swiss AR for all medical devices imported into Switzerland.

The appointment of a Swiss AR cannot happen overnight. Even once the manufacturer has identified the most convenient entity in Switzerland, the designation process entails, at a minimum:

Contract negotiation.
Setting up internal procedures in the manufacturer’s Quality Management System to describe the communication processes.
Agreement on the logistics to ensure the most suitable means of sharing information and documents (including the medical device’s Technical Documentation).
Implementing the Swiss Authorised Representative’s particulars on the device labelling, as required.

It is therefore recommended that manufacturers based outside of Switzerland or currently represented by a European Authorised Representative not based in Switzerland start the process preparation as soon as possible.

epmodex as your new Swiss AR will help you to continue your growth in selling your products in Switzerland even under these circumstances. Use our wealth of experience and challenge our top-level service!

Keen to learn more?

CLICK HERE

Frequently asked questions (FAQ)

Q&A about Swiss Authorized Representative with Martin Epper from epmodex

Swiss Authorised Representative

As a medical device manufacturer, why do I need a Swiss Authorized representative?

On May 26, 2021, the European Medical Device Regulation (MDR) and along the temporary Medical Device Ordinance (MedDO) came into force. All manufacturers not domiciled in Switzerland therefore have to comply with specific Swiss requirements per MedDO. This includes the appointment of a Swiss AR for all medical devices imported into Switzerland

What are the duties of the Swiss Authorised Representative?

When do foreign manufacturers need to take action?

How closely does a CH-Rep and a manufacturer typically work together?

For MDR products the situation is quite clear, the provisions according to MedDo Art. 104a and the respective transition periods apply. But what applies to MDD products whose certificates are still valid until 2024? Does a Swiss authorized representative have to be installed already now, but without mentioning his address on the label? When should the mandate process be started?

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?

Should the foreign manufacturer communicate directly with Swissmedic, e.g. in the event of incidents/complaints, or should this be done via CH-REP?

Product Registration

When must a product be registered and by whom? When is the deadline for registration?

The following timelines apply to manufacturers established in an EU/EEA state or which have an authorised representative in an EU/EEA state.
-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
All other foreign manufacturers are required to appoint a Swiss authorised representative with effect from 26 May 2021.

Registration of Economic Operators

Who has to register as an economic operator and when? When is the deadline for registration? What information is required for registration, and has guidance or other information by competent authorities already been issued?

Manufacturer, Importer and Swiss-AR have to register for CHRN at Swissmedic within 3 month after placing a product on the Swiss Market. Or in any case latest until 26.11.2021. Information required: Address Manufacturer, Correspondance language, Address PRRC, Invoice Address, certificate commercial register.

CHRN Swiss Registration Number

Who will need to assign for a CHRN ? Does it need to be on device labeling?

The Swiss Single Registration Number (CHRN) is a unique identification number. Only Swiss Manufacturers, -Representatives and Importers have to assign at Swissmedic. Manufacturers, importers and authorized representatives who are not based in Switzerland can register via EUDAMED here:Actor registration module | Public Health (europa.eu) It's not needed to put the CHRN on the device labelling.

Obligations for MDD/ AIMDD devices

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.

Labeling of Legacy Devices (MDD)

Does the labeling of devices already placed on swiss market under MDD need to be changed to reflect Swiss Authorized Representative?

For legacy products which have been placed under MDD before May 26th 2021 no additional labelling with the Swiss-REP address is necessary until the expiry date on the certificate

Does the European Authorized Representative shown on the labeling need to be changed to Swiss Authorized Representative?

If there is no significant change on the device, could these device be continuously provided to the market?

Is there any change that must be made to the label on the Medical Device itself?

Labeling of MDR Devices

Can MDR compliant products be placed on swiss market without changing the labeling? Given that the manufacturers European NB can comply with the requirements of Article 25-4 (a) (b)

No, for new products, launched after May 26th 2021(under MDR), the following transition periods for the installation of an SAR according to Art. 51 (1) apply:

-Until 31.12.2021 Class III, implantable devices Class IIb and active implantable medical devices
-Until 31.03.2022 non-implantable devices class IIb and devices Class IIa
-Until 31.07.2022 Class I, systems and treatment units

Validity of Notified bodies in Europe

Can certification bodies in the EU continue to perform conformity assessments for products to be placed on the market in Switzerland?

Yes, but the products have to meet Swiss Requirements. The files have to be reviewed by a Swiss-Rep before placing on the market.

As a foreign manufacturer do we need to contract a new certification body for Switzerland?

Article 25 states that if the conditions a) and b) are met, the issued certificate is valid, but who will demonstrate compliance with a) and b)? a. the conformity assessment procedures applied meet Swiss requirements; and b. they are issued by a body with qualifications equivalent to those required in Switzerland.

Treatment of other European Directives

What will happen with other European Directives such as RoHS / Machinery Directive / Radio Equipment Directive / WEEE etc. We think that these directives are not affected by MRA but are not certain. Do we have to deal with the swiss version of these directives too?

The Mutual regognition agreement was valid for other product sectors (e.g. machines, medical devices, electrical devices, building products, elevators, biocidal products) as well. In terms of value, the agreement covered around two thirds of trade in industrial products between Switzerland and the EU. This means that if there are any Swiss regulations/directives for the RoHS / Machinery Directive / Radio Equipment Directive / WEEE etc.. they need to be fulfilled, since the automatic recognition is not given anymore.

SYSTEM REALIZATION

epmodex is your systems realization partner

Systems Engineering is the key when merging different technologies together. Or further, on security-relevant missions that cannot be examined on the basis of a prototype run. Systems Engineering is an established standard- not only in the medical device industry. It is firmly anchored in projects and in the organization. Without the holistic and systematic approach and the consistent use of methods and processes of systems engineering there's no guarantee for a successful project implementation as "first time right".

We ensure that the result meets the requirements, and in the first attempt and at the right time. The methodology is established where complex interrelationships prevail or where safety-critical aspects have an impact and human lives are in danger. Nothing is left to chance and may go wrong with the introduction. Therefore, Systems Engineering has been used in our projects for years.

We offer precisely interlinked and modular services for complex products associated with very small error tolerances, high standards of documentation and very detailed change management– all in accordance with ISO 9001 and ISO 13485.

Thanks to our team of qualified experts, our clients benefit from technical expertise in all areas of product realization and product life cycle management. We can guarantee quality, short lead times and punctual delivery thanks to our comprehensive expertise and end-to-end processes – as a one-stop shop.

PROJECTS

Smart medical technology serves the well-being of patients and makes doctors' work easier. We support the industry with our broad knowledge in development- and regulatory aspects.

PLASS RESCUE OCCLUDER

A technology that can save lives

The device is specifically designed to prevent haemorrhage due to trauma. Haemorrhage is the leading preventable cause of death in the military setting and the second most leading cause of death in trauma patients in civilian setting.

Form follows intuitive handling: Those were the customer’s requirements at the beginning of the project. epmodex developed a “proof of concept” and diverse functional prototypes of the new rescue device system for verification purpose.

NOBEL BIOCARE

Designing for life

epmodex supported Nobel Biocare in a remediation program of their technical- and risk management file documentation for MDR compliance. We further supported them as an advisor in design risk management aspects for a compliant execution of their development projects in close cooperation with research, product development- and operations divisions.

QUALITY IS OUR HIGHEST PRIORITY

Accuracy- The key for success

It is one thing to develop products and bring them to the market but another to provide superior quality in a standardized serial production that you can count on. Quality assurance comes first priority at epmodex!

We continually develop and optimize our business organization to rest assured that you can fully rely on our quality- today, tomorrow and in the future.

We measure precision

One of our key steps is the precise measurement in all sectors and models. In order to avoid even the smallest errors we use high-end measuring equipment and- methods for dimension control (e.g. 3D- Measurement Machines CMM, CT-Scanners, etc.) conducted by our carefully selected qualified operators.

Test equipment management - It's no coincidence

Properly functioning testing equipment for quality monitoring is essential, as this is the basis of any quality assurance.
The ISO 13485 framework for the manufacture of medical technology products obliges our customers to apply CAPA measures (Corrective and Preventive Actions), to guarantee traceability and change control throughout, to implement risk management that conforms to standards, and to make consistent use of training and document management. In order to meet these numerous requirements, a management system is needed that guarantees complete documentation and comprehensive monitoring and enables rapid, cross-departmental responses to changes of all kinds.
For this purpose, we use a powerful software in production that supports the management of test equipment, test equipment capability studies and the calibration of test equipment. From simple calipers to the most complex, multidimensional measuring equipment, from dial gauges to specialized and process-integrated in-house developments. We thus guarantee for an integrated test equipment management at the highest level.

We care just like: Trust is fine, control is essential!