The SwissMedic, the authority responsible for medical device regulations in Switzerland, has published, in coordination with the EU and MDR, updated regulations: new Medical Devices Ordinance (MedDO) and Clinical Trials for Medical Devices Ordinance (ClinO-MD). These new regulations have been recently adopted by the Federal Council, the Swiss main legislative body.
Swiss Medical Device Regulatory Background
The SwissMedic acknowledges the importance of continuous improvement of regulations in the sphere of medical devices. In particular, the authority deems such changes necessary due to the increasing number of incidents associated with the use of medical devices. According to the position of authority, it is important to improve the regulatory framework to ensure that only the devices that comply with the applicable safety and performance requirements are allowed to be marketed in Switzerland.
The Medical Devices Ordinance (MedDO) has been initially introduced on January 1, 2002. By introducing the MedDO, Switzerland has implemented the rules and requirements for medical devices contained in the appropriate EU Directives. The first significant set of amendments to the initial MedDO took effect on April 1, 2010, and was intended to harmonize Swiss medical device regulations with the newest version of European regulations.
Switzerland is also a party to the international agreements on mutual recognition in the field of conformity assessment (the Mutual Recognition Agreement (MRA) dated June 21, 1999).
In order to ensure the application of the same high standards and requirements for medical devices as ones applied in the EU, the Swiss Confederation takes all the steps necessary to align the national legislation on medical devices to the latest international regulations implemented in the European Union. Such harmonization is also important in the context of participation in a single European market for medical devices, providing that Swiss products are allowed to be marketed in the EU and vice versa.
In the course of regulatory harmonization and collaboration with the European Union, Switzerland is going to participate in the new EU expert groups on medical devices, and also to designate and to recognize the designation of the notified bodies.
It is also important to mention that earlier in March 2019, important amendments were implemented to some Swiss regulations in the sphere of healthcare, namely:
- The Therapeutic Products Act, and
- The Human Research Act.
According to the initial plan, these amended versions of the regulations should have entered into force on May 26, 2020, together with the Medical Devices Regulation 2017/745 (MDR), the new EU regulation on medical devices. However, their actual implementation has been postponed due to the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by the virus “SARS-CoV-2” or the “novel coronavirus,” and the impact of the special extraordinary measures associated thereto. The decision to postpone the implementation of the pending changes is based on the MDR implementation delay announced by the European Commission.
The SwissMedic states that the amendments to the Swiss regulations on medical devices will be implemented in several steps. In particular, the derogation’s rules will become effective on August 1, 2020. According to these rules, medical device manufacturers, their authorized representatives, and importers would be allowed to place on the market the devices without a conformity assessment, providing that all mandatory preconditions are met. Such exclusion could be applied if the medical device in question is vitally important for public health protection, and risks associated with the use of such devices are less significant from the appropriate benefits.
The authority also informs that the amended requirements on clinical trials, marketing, and post-market surveillance will become effective since May 26, 2021, together with the MDR. The regulations on in vitro diagnostic medical devices will be implemented as a separate document which will take effect on May 26, 2022, together with the Regulation on In Vitro Diagnostic Medical Devices 2017/746 (IVDR). The authority also mentions that the MRA would be subject to certain changes and improvements too.
MedDO Amendments Explanatory Report
In order to assist medical device manufacturers and other industry representatives in maintaining compliance with the upcoming regulatory changes, the SwissMedic issued an explanatory report – a special documents providing main stakeholders with the most important information related to the amended regulations and the way these amendments will be implemented.
The SwissMedic acknowledges the importance of the medical device industry in the economy of the country. In particular, more than 70 percent of medical devices manufactured in Switzerland are being exported. Thus, the efficient regulatory framework is important to ensure further development of the industry in general.
The document also provides additional information regarding the structure of the document and the content of its provisions. According to the explanatory report, the Swiss regulation on medical devices covers, inter alia, the following aspects:
- Applicability of the regulation, determination of the scope of the devices subject to regulation under the MedDO,
- Exceptions – a set of rules describing the conditions under which certain medicinal products could be exempted from regulation,
- Definitions of the most important terms, that are necessary to apply the regulations in a correct way,
- References to the appropriate European regulations covering the same aspects,
- General safety and performance requirements any medical device should comply with in order to be allowed for marketing and use it Switzerland,
- Special rules to be applied in case of distributing medical devices via the Internet,
- Rules to medical devices manufactured by healthcare facilities and intended for in-house use (according to the general rule, such medical devices are subject to regulation under the simplified framework due to the lower risk associated with their use),
- Requirements for custom-made medical devices,
- Labeling and identification requirements,
- Risk-based classification rules, and others.
Thus, the amended regulation on medical devices covers all important aspects related to conformity assessment, importation, and distribution of medical devices in Switzerland.
New Swiss Medical Devices Regulation: Key Points
The amended regulations will introduce several new concepts intended to make the regulation in the sphere of medical devices more efficient and up-to-date with the modern trends and needs.
In particular, the Swiss regulation on medical devices will now contain special rules and requirements to be applied if:
- the medical device is being supplied directly to the end-user (patient), or
- medical services are being provided remotely.
In fact, this concept implements principles introduced by the MDR. In terms of distance selling, the Swiss regulation provides the following:
- The “distance selling” concept should be applied if medicinal products are being offered via the Internet.
- The appropriate rules should be applied for products that are not properly placed on the Swiss medical devices market but nevertheless are available to Swiss customers.
- Medicinal services offered remotely for a fee should be also subject to regulation.
- SwissMedic is entitled to require any e-commerce service provider to discontinue the availability of certain products in Switzerland if such products are failing to comply with the applicable safety and performance requirements.
Summarizing the information provided hereabove, the upcoming changes announced by SwissMedic are intended to align Swiss regulations on medical devices with the appropriate European regulations and rules in order to improve the overall safety and quality of medical devices marketed in Switzerland.
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