SWITZERLAND Law and Practice Contributed by: Oliver Brupbacher, Markus Schott, Markus Wang, Djamila Batache and Christine Schweikard, Bär & Karrer AG
Medical Devices For medical devices, Switzerland currently does not explicitly provide a fast track registration route, meaning there is no expedited conform- ity assessment procedure. However, in excep- tional cases, Swissmedic may – upon a duly justified request – authorise the placing on the market and use of a specific medical device in the interest of public health or patient safety, even if the full conformity assessment has not been completed (eg, because the device has not undergone a complete conformity assess- ment procedure or the certificate for a device for the device has been declared invalid) or the language requirements are not met (Article 22 paragraph 1 of the MedDO and Article 18 para- graph 1 of the IvDO). Article 22 paragraph 2 of the MedDO and Article 18 paragraph 2 of the IvDO permit the placing on the market and use of individual devices without valid certificates in an individual case if the fol- lowing conditions are fulfilled: • the device serves to avert life-threatening conditions or to prevent the permanent impairment of a bodily function or, in the case of in vitro diagnostic medical devices, is used to test samples with the aim of averting or treating life-threatening conditions or perma- nent impairments of a body function; • no conforming device is available for this specific intended purpose; • the device is used exclusively by HCPs either directly on an individual patient or in a labo- ratory setting for patient-specific sample testing; • the HCP using the device or providing treat- ment has informed the patient about the non- conformity of the device and the associated risks; and
• the patient concerned has provided consent for the use of the device. The decision to use a non-conforming device must be based on a thorough risk–benefit assessment for the specific case. A Swissmedic authorisation is not required for these cases (see Swissmedic information sheet “Derogation MEP” ). However, the exemption is limited to the manufacturer or importer making the device available to the user for the first time. Devices authorised under these exceptional provisions must not be traded or made widely available on the market. To ensure compliance with Article 22 paragraph 2 of the MedDO and Article 18 para- graph of the IvDO, the responsible HCP must document compliance with the specified condi- tions and retain all relevant records for regulatory verification. 4.2 Regulatory Reliance Medicinal Products Swissmedic may expedite the approval pro- cess for certain medicinal products if they have already been authorised by internationally rec- ognised regulatory bodies, such as the Europe- an Medicines Agency (EMA), the US Food and Drug Administration (FDA), or others. Applicants seeking authorisation, an extension, or a variation for a medicinal product or proce- dure that has already been approved in a country with a comparable regulatory system may bene- fit from Swissmedic’s reliance on foreign assess- ment results (Article 13 of the TPA) – provided the following conditions are met. • The submitted foreign authorisation docu- ments, including all variations, must be no older than five years and reflect the product’s current approval status abroad (Article 16 lit a of the OMP). Minor deviations from the
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