The second article addresses specific matters associated with the use of medical devices in healthcare institutions, including the obligations in the sphere of incident notification or direct import.
Swissmedic, the country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the regulatory requirements for procurement of medical devices to be used in healthcare institutions. The document highlights the most important aspects to be considered for the safety and quality of medical devices and also outlines the spheres of responsibility of the parties involved. In particular, the guidance pays special attention to such aspects as:
- Responsibilities of authorized representatives;
- Proper examination of medical devices by healthcare institutions;
- Requirements for medical devices imported by healthcare professionals;
- New requirements for procurements for healthcare institutions;
- Quality defects and non-compliance with respective regulatory requirements.
Swiss Agents and Importers
First of all, the authority mentions that since the agreement between Switzerland and the European Union has not been renewed, foreign medical device manufacturers are obliged to appoint local authorized representatives in Switzerland to be allowed to place their products on the country’s market. However, the actual implementation date for this requirement could be different depending on the class of a medical device in question, namely:
- High-risk medical devices (implantable and AIMD of classes III, IIb) – Dec. 31, 2021;
- Moderate risk devices (non-implantable class IIb, IIa products) – March 31, 2022;
- Low-risk medical devices (class I) – July 31, 2022;
- Systems and cleaning equipment – July 31, 2022.
The timelines above are applicable for medical device manufacturers based or already having their authorized representatives in the EU/EEU. For any other manufacturers, the requirement to appoint an authorized representative is already applicable since May 26, 2021. Moreover, starting from this date, the labeling or information accompanying the device should contain information about the Swiss importer.
Examination of Medical Devices
Under the general rule, medical device manufacturers are the ones mostly responsible for the quality of their products, as well as compliance of the latter with the applicable safety and performance requirements. Hence, healthcare institutions using medical devices should pay special attention to the choice of proper suppliers and products. The authority additionally emphasizes that any person dealing with medical devices should take all the measures to ensure the use of the device will not create additional risks for health.
According to Swiss legislation, only medical devices bearing a valid CE marking are allowed for use in the country. The authority further provides clarifications regarding the way the validity of such a marking could be verified – the appropriate information is contained in annexes to the present guidance.
Direct Import Requirements
In certain cases, healthcare institutions or healthcare professionals can import medical devices directly for their use, without placing such devices on the market. In such cases, a person or an entity would not be considered as an importer, and the respective requirements related to testing, registration, or documentation would not be applicable.
The aforementioned approach applies if:
- The products are intended to be used within the same legal person (healthcare institution); or
- The products that remain to be owned by the patient (e.g., implants).
In the case of direct import, a specialist importing the device and using it would be responsible for the product and its compliance with the applicable regulatory requirements. The institution using such devices should ensure they have conformity marking which demonstrates that the appropriate conformity assessment procedure has been completed. At the same time, since the products are not intended to be placed on the Swiss market, there is no need to indicate an authorized representative in Switzerland.
The usual scope of responsibilities of an authorized representative covers the aspects related to incidents and adverse events associated with a medical device, for which a representative will be responsible together with a medical device manufacturer. A representative should be also responsible for safety-related matters associated with placing the device on the market. In the case of directly imported devices, none of the Swiss entities will be responsible for them, except the ones where these products are used. This situation could result in certain issues related to the actual effectiveness of post-market surveillance. Hence, healthcare institutions and specialists using directly imported medical devices should take all the measures necessary to ensure an efficient information exchange for corrective and preventive actions.
Due to the reasons described hereinabove, the authority encourages healthcare institutions and specialists to use products of either Swiss manufacturers, or the ones having authorized representatives duly appointed in Switzerland, while direct import should be used only in exceptional cases.
Should a healthcare institution or specialist directly importing medical devices provide them to third parties for payment for free, such an institution/specialist would be considered an importer and, consequently, be obliged to follow the respective regulatory requirements. Moreover, for such products, an authorized representative should be duly appointed in Switzerland.
New Procurement Requirements
The document also provides an overview of the new procurement requirements to be followed by healthcare institutions. However, the authority additionally emphasizes that the list provided therein is not exhaustive. The aspects to be considered when procuring medical devices should include, inter alia, the following ones:
- Traceability – unique device identifiers should be used at least for implantable class III medical devices.
- Implant cards – such cards are to be in place in three national languages.
- Refurbished single-used medical devices – while the use of refurbished medical devices is allowed under the EU laws, it is prohibited under the applicable Swiss legislation.
Defects of Quality and Non-Compliant Medical Devices
According to the applicable legislation, healthcare institutions are obliged to notify about serious incidents associated with medical devices. The appropriate notifications should be provided to both suppliers and Swissmedic. Should a healthcare institution have any suspicions, e.g., to the validity of a certificate, it should notify the authority as well, while the latter will receive a report on suspicious activity, analyze it, and take the appropriate measures depending on the risk.
Apart from the aspects described hereinabove, the document also provides a list of regulations to be applied to the matters described therein. According to the guidance, the applicable legislation includes:
- Heilmittelgesetz (HMG): Bundesgesetz vom 15. Dezember 2000 über Arzneimittel und Medizinprodukte; SR 812.21
- Medizinprodukteverordnung (MepV) vom 1. Juli 2020; SR 812.213
- Altrechtliche Medizinprodukteverordnung (aMepV) vom 17. Oktober 2001 (Stand am 01. August 2020); SR 812.213 (Bestimmungen für In-vitro-Diagnostika).
In summary, the present document published by Swissmedic covers the most important aspects associated with the procurement of medical devices to be used by healthcare institutions. The document clarifies the responsibilities of the parties involved and also describes the way of action to be followed in specific cases.
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