Nomenclature of medical devices

Nomenclature of medical devices

Medical devices are those products used to prevent, diagnose, treat, and monitor the many diseases known to humankind. Medical devices and medicines play an equally important role in treating human beings. To learn more about medical devices, read our article on the definition of a medical device. This article discusses the nomenclature of medical devices and examples of these.

What is the nomenclature of medical devices?

To simply put it, the nomenclature is the naming of a medical device. Although medical devices are classified into different risk classes, they should be named so that it is universally identified. Standardised nomenclature facilitates this easy identification.

A nomenclature is needed to simplify trade and tracking among the different regulatory authorities, Ministries of Health, and other organisations that regulate medical devices.

A standardised nomenclature aids in the following aspects:

  • Grouping and classification of medical devices.
  • Registration under different regulatory bodies or Ministries of Health
  • Streamlined procurement and distribution
  • Grouping of medical devices in various electronic health records and medical device databases
  • Vigilance reporting, field safety and post-market surveillance
  • Unique Device Identifiers (UDI)

Medical Device Nomenclatures

The different device nomenclatures available are as follows:

  • GMDN or Global Medical Device Nomenclature.
  • EMDN or European Medical Device Nomenclature
  • UMDNS or Universal Medical Device Nomenclature System
  • Other nationally developed nomenclature systems

Global Medical Device Nomenclature (GMDN)

About 10% of countries use Global Medical Device Nomenclature worldwide. It is a system of internationally accepted descriptors used to identify medical devices. The GMDN Agency manages GMDN codes, a non-profit organisation.

GMDN is a 5-digit code containing the following information:

  • GMDN Term Name: Anaesthesia ventilator
  • GMDN Code: 34851
  • GMDN Definition: A mains electricity (AC-powered) stand-alone, automatic cycling device used to assist and control alveolar ventilation during general anaesthesia and is compatible with inhaled anaesthetic agents. It has fewer functions and is less complex to operate than an intensive care ventilator but adequately meets the patient’s ventilation needs for oxygen (O2) and carbon dioxide (CO2) exchange to maintain normal blood gas concentrations. The device provides a mechanical means to deliver the breathing gas to the patient in a controlled pattern. It is equipped with alarms to warn of changes in respiration or the onset of unsafe operating conditions.

Source: gmdnagency.org

GMDN was introduced for a variety of regulatory purposes. GMDN is based on the ISO 15225: Medical device nomenclature data structure’. Read more about the frequently asked questions about GMDN here.

European Medical Device Nomenclature (EMDN)

European Medical Device Nomenclature or EMDN is introduced due to Article 26 of EU Regulation 2017/745 of Medical devices and Article 23 of EU Regulation 2017/746  of in-vitro diagnostic medical devices. Like GMDN, it plays a considerable role in device nomenclature and serves various regulatory purposes. One of the primary uses is while registering a medical device in EUDAMED where it is closely linked to UDI-DI.

Structure of EMDN

The European Medical Device Nomenclature is characterised by its alphanumeric structure and is established in a seven-level hierarchical tree where it clusters medical devices into three primary levels:

Categories: the first hierarchical level – alphanumeric.

Groups: the second hierarchical level – 2 numbers indicating group.

Types: the third hierarchical level – a series of numbers 1,2,3,4 and 5.

EMDN was adopted from the Classificazione Nazionale Dispositivi medici (CND) classification. The EMDN can be accessed at the EMDN list. European Medical Device Nomenclature categorises into three primary levels, categories, groups, and types. A category comprises several groups composed of various kinds of medical devices.

Source: https://webgate.ec.europa.eu/dyna2/emdn/. In the above image of EMDN, ‘A’ is the category, ‘A01’ is Group and ‘A0101’ to ‘A0199’ are the types of medical devices.

Universal Medical Device Nomenclature System (UMDNS)

Universal Medical Device Nomenclature System or UMDNS was developed by the Emergency Care Research Institute (ECRI). Many nations have adopted this standard around the world. UMDNS is used in inventory control, work order control, and regulatory systems applications. It is a 5-digit code unique code and a term for different types of medical devices. One can find the UMDNS code list here. UMDNS is updated monthly.

CND Nomenclature

CND nomenclature or ‘Classificazione Nazionale Dispositivi medici’ was developed by Italian Ministry of Health. In addition to Italy, it is also used in Portugal and Greece. The guidance document on CND nomenclature explains the basic principles and structure of CND, which also applies to EMDN as EMDN was adopted from CND nomenclature. Following this, medical devices are clustered into three levels:

  • Category
  • Group
  • Type

FAQs

Is UDI the same as GMDN?

Both Unique Device Identification System (UDI) and GMDN are used in device identification. However, the two have some fundamental differences. UDI is inferior because of its lack of unity. It does not have a structure; therefore, device identification becomes more difficult with UDIs. Nonetheless, it is an effective tool for the traceability of medical devices. FDA utilises UDIs for medical device identification. The user guide to GUDID explains how the UDIs are managed in US FDA’s database, GUDID.

Can EMDN be accessed free of charge?

The EMDN is accessible to all stakeholders- free of charge. Hence, it can be utilised by a non-exhaustive list of stakeholders such as manufacturers, patients, research organisations, practitioners, hospitals, etc. The EMDN can also be downloaded from here.

Is there a guidance document that helps economic operators to map the EMDN information into the forthcoming EUDAMED database?

Yes, there are two guidance documents released by the EU commission

Labelling Requirements – Swiss Authorized Representative

Labelling Requirements – Swiss Authorized Representative

Label

Written, printed, or graphic information appears either on the device itself or on the packaging of each unit or the packaging of multiple devices (Art. 2 point 13 MDR). Timeline for Information on Indication of CH-REP “on the device” or “in the accompanying document.”

The provision for indication of CH-REP comes into effect on 26 May 2021 and is timeline based, applicable to devices of all classes (Class I, IIa, IIb, III). For imported devices, the CH-REP should be indicated according to the below table:

Device ClassCH-REP Symbol / Indication to be placed on
Class I MDR DeviceWith effect from 26 May 2021 Until 31-Jul-2023 Where: Either on the label (or) On the Document accompanying the device After 31-Jul-2023 Where: On the label
Class IIa, IIb, III MDR DevicesWith effect from 26 May 2021 Where: On the label
MDD/AIMDD Devices with EU/EEA manufacturer or EC-REPWith effect from 26 May 2021 Where: MDD – On label (or) Instructions for Use (or) In Document accompanying the device   AIMDD – On sales packaging (and) Instructions for Use (or) In Document accompanying the device
MDD/AIMDD Devices without EU/EEA manufacturer or EC-REPWith effect from 26 May 2021 Where: MDD – On label (or) Instructions for Use   AIMDD – On sales packaging (and) Instructions for Use

“CH-REP” Symbol

Representation / Usage of the “CH-REP” Symbol on the Device packaging

  • The name of the Swiss AR must be available on the product label.
  • The Name and Address of the Authorised Representative (AR) must appear adjacent to the symbol.
  • The mentioned Address must enable provision to contact the Swiss AR with sufficient contact details.
  • The symbol’s size and name are not defined; however, they must be adequately visible to the naked eye.

Symbols to Use

Where symbols are used, they must conform to the harmonised standards. Swiss medic rule allows the sole use of the symbol without any description of the symbol explained in the product documentation enclosed.

Other CH-REP Representation(s)

Instead of the symbol, Swiss medic also permits the indication as stated below:

“CH-Authorised Representative”

“CH-REP”

“Authorised Representative for Switzerland”

Rules for Manufacturers from EU/EEA

Manufacturers placed in the EU/EEA also fall under this obligation to appoint their Swiss AR (called CH-REP or Swiss Rep or SAR). It is least expected that a single CH-REP is appointed for devices that belong to the same medical device group or family.

Source Reference Links

MedDO Ordinance – Swiss MedDO 812.213

MedDO Article 51 – Obligations of Swiss AR

MedDO Article 104a – Timeline to Appoint AR

Swiss Medical Device Labelling Requirements – Chapter III of Annex I to EU-MDR 2017/745

FAQs

What does “In a document accompanying the device” mean and where should I make this information available?

This information can be affixed to the device or be available separate from the device. Available separate refers to documents such as delivery notes, customs documents, guarantee certificates, invoices, a sticker on the packaging or the instructions for use.

Such documents are made available with the device throughout the supply chain route. It is available until it reaches the distributors and need not be necessarily available to the end customer. Note that this accompanying interpretation differs from the Swiss with EU MDR.

Is the definition of a “document accompanying the device” of Swiss MedDO and Europe’s MDR 2017/745 the same?

No, they are not the same. The interpretation of document accompanying the device definition differs from Swiss MedDO and EU MDR.

In what languages must the medical device product information such as Labelling and Instructions for Use be written for the Swiss market?

It must be written and made available in all three official languages of Switzerland (German, French and Italian). Symbols established by using technical standards may be used to replace the written statements.

Swiss MedDO Information sheet on Economic Operators

What are the other obligations of a Swiss AR / CH-REP?

A detailed obligation/responsibilities of a CH-REP are available in our article Obligations of the Swiss Authorised Representative.

Who are the Economic Operators required to be registered with Swiss medic?

  • Manufacturers (or) their Swiss Authorised Representative must register themselves within three months of placing the device for the first time in the Swiss market.
  • During registration, they must cater information as per Part A of Annex VI EU MDR 2017/745. Further obligations and registration modalities are governed by Article 30 and Article 31 of EU MDR 2017/745
Swiss Manufacturer Obligations

Swiss Manufacturer Obligations

1. Manufacturers outside Switzerland will need to appoint Swiss AR.

2. The Manufacturer will use commercially reasonable efforts to update its technical
documentation for the devices, to comply with the requirements of the ordinance, and to complete a conformity assessment procedure for devices in due time prior to the expiration of their current certificate of conformity.

3. The Manufacturer reserves the right but needs to inform AR about any discontinuities of the devices upon expiration of their current certificate of conformity.

4. As per the latest application of the ordinance, for all devices made available on the Swiss market, the manufacturer should ensure:
I. The device should be CE marked.
II. The technical documentation and the declaration of conformity of the device has been drawn up.
III. Requesting Swissmedic for the Swiss Single Registration Number (CHRN), which is used to identify the manufacturer, authorised representative, or importer and is will also need to register in the EUDAMED database issuing the Single Registration Number (SRN).
IV. Labelling of the device in accordance with the ordinance accompanied by the required Instructions For Use (IFU).
V. Assigning UDI to medical devices before placing them in the market and reporting to Swissmedic.
VI. Establishment of a post-market monitoring system and defined necessary corrective measures.
VII. Maintenance of the quality management system.

5. Manufacturers should report serious incidents associated with their medical devices to Swissmedic and should also initiate a Field Safety Corrective Action (FSCA) monitored by Swissmedic for the medical devices placed on the market in Switzerland. FSCA is used to reduce risk of death or severe deterioration in the health of the end-user associated with the medical device and may include the return of a medical device to the supplier, device – modification, exchange, or destruction.

6. The Manufacturer will not delegate to the AR the obligations laid down in Articles 16 – 17, 46 – 47, 50, 56, and 66 of the ordinance. The corresponding obligations in the (EU) 2017/745 are Article 10 (1) – (4), (6) – (7) and (9) – (12).

Switzerland AR Responsibilities

Switzerland AR Responsibilities

Obligations of the Swiss Authorised Representative

1. Verify the DoC and technical documentation have been drawn up and where necessary conformity assessment procedure has been carried out.

2. Keep available a copy of the technical documentation, the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, at the disposal of competent authorities for a period as defined in the section «Records» of this agreement.

3. Register itself on the electronic system «EUDAMED» and obtain the Single Registration Number (SRN)

4. Verify that the manufacturer has complied with the registration obligations in EUDAMED by entering the UDI core data elements (as per Article 27 of (EU) 2017/745) and has assigned and entered in Eudamed the Basic UDI-DI Information of the devices (as per Article 29 of (EU) 2017/745).

5. In response to a request from the competent authority, provide the competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official language determined by the competent authority.

6. Forward to the manufacturer any request by a competent authority for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device.

7. Cooperate with competent authority on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices.

8. The AR is equally liable for any defective device in the Swiss market when either of the parties does not fulfil their obligations in accordance with the Ordinance. Therefore, it is important to consider the inclusion of AR in the corresponding processes and management reviews as deemed necessary.

9. Immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device.

10. AR shall ensure that it has permanently and continuously at its disposal at least one the person responsible for regulatory compliance who possesses the required expertise (as per article 52 of MedDO / article 15 of (EU) 2017/745) regarding the regulatory requirements for medical devices in Switzerland. The PRRC shall comply with its responsibilities as defined in the Ordinance.

11. The PRRC of AR is responsible to verify the quality functions of the manufacturer (if conformity of the device is checked as per the QMS, the PMS obligations, reporting obligation of incidents, issuance of the signed statement confirming the safety of the investigational device). This could be facilitated by allowing the PRRC of AR to have access to the QMS documentation. For example, the PRRC of AR could be part of the internal audit of the manufacturer.

12. The AR is legally liable for defective devices on the Swiss market on the same basis as, and jointly and severally with, the manufacturer when the manufacturer has not complied with its obligations according to article 10 of (EU) 2017/745

Swiss Regulation QA WHITE PAPER

Swiss Regulation QA WHITE PAPER

MEDICAL DEVICE REGULATION
UPDATE IN SWITZERLAND

1. Who is responsible for medical device regulation in Switzerland?

The Swiss Agency regulates medical devices for Therapeutic Products (Swiss medic)

2. Which current Switzerland medical device regulations need to be followed by stakeholders?

From May 26th, 2021, Stakeholders need to follow the revised Medical Devices Ordinance. (MedDO) and a new Ordinance on Clinical Trials with Medical Devices (CTO-Medd).

3. What is the EU- Switzerland mutual recognition agreement (MRA)?

EU- Switzerland mutual recognition agreement (MRA) is a crucial agreement between the EU and Switzerland. It allows the bilateral trade of several goods like medical devices, heavy machines, vehicles, etc. This MRA allowed mutual recognition of conformity assessment certificates between Europe and Switzerland.

4. What is the status of the EU-Switzerland mutual recognition agreement (MRA) for medical devices?

MRA is not updated on May 26th, 2021. As a result, the new medical device regulation of the European Union, i.e., EU MDR 2017/745, is not included in MRA. MRA has previous directives 90/385/EEC and 93/42/EEC in the medical chapter.

5. What are the consequences of this MRA status on the Swiss manufacturers/authorised representative who wants to place their products on the EU market?

From now on, Switzerland will be treated like a third-world country by the European Union. Manufacturers & authorised representatives based in Switzerland will need to appoint an EU Authorised representative in the EU and followed EU-MDR 207/745 to place medical devices on the EU market. Medical devices will need to undergo conformity assessment procedures by Notified Bodies in the EU to get CE certificates. All the existing CE certificates based on directives 90/385/EEC and 93/42/EEC under the MRA will not be considered valid in the European Union.

6. Which regulations do I need to follow in order to place my device on the swiss market?

Manufacturers will need to follow the revised Medical Devices Ordinance (MedDO) to place their products in Switzerland.

7. What are MedDO requirements?

Primary requirements of MedDO include the appointment of Switzerland authorised representative (Switzerland AR) for manufacturers based outside of Switzerland, economic operators registration and continuous reporting of severe incidents to Swissmedic, UDI assignment, and device notification.

8. Who needs to register with Swissmedic?

Economic operators (manufacturers, importers, authorised representatives placed in Switzerland) need to register themselves with Swissmedic in the first three months of

placing the device in the market. After successful registration, they will be assigned a Swiss Single Registration Number (CHRN). The Swiss Single Registration Number (CHRN) is a unique identification number to identify. Economic operators who already sell products before May 26th, 2021, in accordance with MDR 2017/745 & IVDR 2017/ 746, registrations in accordance must be completed by November 26th, 2021.

9. What is the process of economic operator registration with Swissmedic? What are the registration fees?

The economics operator needs to submit the information to Swissmedic with the help of a registration form: Application registration CHRN. Swissmedic will review the information. Once it is successfully reviewed, the economic operator will receive CHRN. For the assignment of CHRN, fees will be based on the amount of review work done by Swissmedic per application. It is CHF 200 per hour.

10. What Information is required by Swissmedic for economic operators registration?

Name of the registrant, contact details, details of the person responsible for regulatory compliance, commercial Register extract, For Swiss-domiciled, authorised representatives to mandate from a manufacturer outside Switzerland is required by Swissmedic.

11. Who can be appointed as Switzerland AR? What is the deadline for appointing Switzerland AR?

A Swiss authorized representative (Swiss AR) is a legal person that needs to be appointed by a manufacturer established outside of Switzerland to place the products on the Swiss market. A written mandate/letter designating an authorised representative for a medical device manufacturer is mandatory. Any legal entity or natural person situated in Switzerland can act as Switzerland AR. Switzerland AR is responsible for product safety and will be held liable for product defects. Manufacturers can appoint only a single Authorised representative in Switzerland.

Timeline to appoint Switzerland AR:

12. Which devices need to be notified to Swissmedic? What is the process?

The following device needs to be notified to Swissmedic before placing it on market:

13. What is the timeline to assign UDI?
For placing UDI- carriers on the labels of the device deadline for implantable devices and
class III devices are 26th May 2021, Class IIa and class IIb devices are 26th May 2023 and for
class I devises it is 26th May 2025.

14. Will the Swissmedic accept CE certificates?
CE certificates from notified bodies placed in EU/EEA countries will be valid in Switzerland until and unless the applied conformity assessment procedures comply with the Swiss requirements meet, and they are issued by a notified body that has an equivalent qualification as described in MedDO.

15. What are the regulations for the In vitro diagnostic devices?
In vitro, diagnostic medical devices regulations are in the final step. They will be published as a separate ordinance on in-vitro diagnostics (IvDO).

What We Offer

  • Act as your Switzerland authorised representative
  • MedDO compliance
  • Economic operator registration
  • Medical device notification
  • EU MDR, IVDR gap analysis

Why Choose Us

  • Working towards client satisfaction
  • Cost-effective solutions
  • Project completion before deadline
  • Quality Regulatory affairs solutions

Contact us for a free consultation: info@omcmedical.co.uk

Switzerland Medical Device Regulations

Switzerland Medical Device Regulations

Switzerland Market Situation

  • As the Institutional Agreement is missing (InstA) is missing, the EU has not updated the Mutual Recognition Agreement (MRA)
  • No barrier-free access to the EU internal market
  • Swiss has been downgraded to the third country
  • Swiss manufacturers have stricter requirements when exporting their medical devices to the EU.
  • The Swiss MedTech industry will have:
  1. The administrative cost of CHF 114 million initially
  2. CHF 75 million annually
  3. Cost represents 2% and 1.4% of total export volume (CHF 5.2 billion) to the
    EU

Switzerland Market Situation – Downside

  • Non-EU manufacturers will not want to have an HQ based in Switzerland
  • Swiss Start ups will move to the EU going forward for ease of trade
  • Swiss has lost the advantage of an Economically important branch of industry with 63,000 employees and 1400 companies.

Switzerland- Medical Device Regulations

Medical devices are regulated by: the Swiss Agency for Therapeutic Product

Manufacturers Outside Swiss

  • After 26 May 2021, foreign manufacturers must appoint a Swiss authorised representative in order to sell their devices in the market.
  • An agreement between the manufacturer and the AR is needed.
  • Who is a Swiss AR

– Proxy to the foreign manufacturer

– Responsible for product safety

– Liable for product defects

– contact person for Swiss authorities

– can be a legal entity or a natural person

– must have access to PRRC

Roles of Swiss AR’s PRRC

  • Same as the role of PRRC for pharmaceutical products
  • It is mandatory for an AR to appoint PPRC or delegate this to an external service provider
  • Assumes a central role in PMS surveillance and in the control of medical devices
  • He/she is personally responsible for the compliance with the duties incumbent on the AR and can be held criminally liable for the violation

Liability of a Swiss AR

  • According to the swiss Product Liability Act, the manufacturer is responsible for any product defects.
  • Swiss Ordinance on medical devices extends liability to Swiss AR
  • AR is jointly and legally liable for any product defects.
  • Liability of an AR cannot be waived by contract.
  • AR and the manufacturer are obliged to take liability insurance with sufficient coverage.
  • The manufacturer, however, may undertake to pay the insurance costs for the authorized representative.
  • AR should do due diligence before signing the agreement with the manufacturer.

Manufacturer Responsibilities

  • The centre of the responsibilities is defined by law.
  • Prove and document conformity of his product, including correct classification.
  • The introduction and maintenance of a QMS system is his responsibilities.
  • AR is dependent on the manufacturer to fulfil its obligations.
  • The manufacturer must be contractually obliged to guarantee the authorized representative full compliance with his legal duties.
  • Legal duties include- CE mark, UDI, IFU, and Translation into Swiss languages.
  • Manufacturers must supply the AR with extensive documentation.
  • The manufacturer is obliged to retain the technical documentation, declaration, and certificate of conformity, including amendments and supplements for 10-15 yrs.
  • AR to keep commercial records for 10 yrs.

Notifications

  • Class I
  • Custom made devices
  • Systems and procedure packs
  • Devitalised human tissue
  • Repacked or relabeled medical devices
  • Medical devices manufactured and used in health institutions in the Swiss
  • IVD and self-testing IVDs, other IVDs
  • IVD manufactured in house

UDI- CHRN

  • The Swiss Single Registration Number (CHRN): Unique identification number
  • Swissmedic assigns CHRN to Swiss manufacturers, authorized representatives and importers
  • Until the MRA (Mutual Recognition Agreement) is updated, Swissmedic is unable to assign a European Single Registration Number (SRN) via EUDAMED for economic operators who are domiciled in Switzerland.
  • Registration with Swissmedic is necessary for CHRN
  • Economic operators must register within three months of placing their first product on the Swiss market.

Update for Manufacturers in EU & Swiss

  • Registration and notification obligations do not run via EUDAMED but via Swissmedic.
  • Economic operators who have already placed products on the market before 26 May 2021 in accordance with the MDR and IVDR must complete their registration by 26 November 2021.
  • Access to the technical documentation may be provided either by keeping a copy available at the authorised representative or by contractually guaranteeing that it will be handed over to Swissmedic upon request within 7 days.
  • The validated Summary of Safety and Clinical Performance (SSCP) is not uploaded by the Notified Body in EUDAMED but published by the manufacturer, for example on its website.

For manufacturers outside Switzerland:

Need to appoint Swiss AR, update the labelling for MDR products & follow
third-country requirements

Timeline to appoint swiss AR:

Swiss Manufacturer exporting to EU:

  • For MDR regulated devices & class I devices: Follow third country requirements from 26th May 2021
  • For MDD certified devices: No third country requirements, they will be regulated under MRA, free access to EU market as before until May 2024.

How we assist you with this process?

  • Act as your Swiss Authorised Representative
  • MedDO Compliance
  • Swissmedic Registrations & Notification
  • Product Information Translations
  • MedDO Gap Analysis