Questions and answers concerning combination products
We are planning to have a new inseparable combination product (integral CP with medical device (MedD) component class Im, Is, Ir, IIa, IIb or III) authorised by Swissmedic. The assessment report (Notified Body Opinion – NBOp) for the MedD component will not be available by the planned submission date of the application. Is it possible to submit an application without an NBOp, i.e. can the NBOp be submitted later?
When applying for authorisation of a new inseparable combination (see also Guidance document Formal Requirements), the following formal requirements must be observed:
In principle, all documents and evidence, including those relating to the conformity of the MedD component with the general safety and performance requirements according to Annex I EU-MDR (NBOp or certificate of conformity), must be submitted together with the authorisation application.
If this is not possible, the applicant can agree a later submission date for the missing NBOp or certificate of conformity for the MedD component with Swissmedic, but this should not delay the approval process for a new authorisation or variation (with the exception of type IB or type IA/IAIN variation applications to be approved in advance or after the fact). This later submission date must be set out in the cover letter, stating the binding timescale, and substantiated with corresponding documentation from the certification body. Since products submitted to Swissmedic for approval that have received the official decision which concludes the approval process are directly marketable, all documents relevant to the approval must be present and be checked before this official decision is issued.
Does Swissmedic accept a Notified Body Opinion (NBOp) that only partially conforms with the requirements of Annex I EU-MDR (partial compliance)? New from September 2024
Swissmedic relies on the assessment of notified bodies, with their specific specialist knowledge of the medical device components concerned, regarding the conformity of the medical device components of a combination product with the general safety and performance requirements (GSPRs). Swissmedic cannot accept an NBOp which concludes that the medical device components only partially conform with the requirements of Annex I of Regulation (EU) 2017/745 on medical devices (EU MDR).
Can conformity assessments and certifications from a notified body which were issued under the old Directives (93/42/EEC (MDD) or 90/385/EEC (AIMDD)) be submitted for an application for new authorisation of a combination product? New from September 2024
For an inseparable combination product (“integral” or “co-packaged”), under the Medical Devices Ordinance (MedDO, SR 812.213), the medical device components must conform with the general safety and performance requirements (GSPRs) according to Annex I of Regulation (EU) 2017/745 on medical devices (EU-MDR) (Art. 2 para. 1 let. f and g, Art. 2 and Art. 6 para. 2 MedDO). The relevant proof can be furnished using the templates for declarations of conformity and certificates according to EU-MDR (CE proof of conformity) or an NBOp as an alternative option for “integral” combination products. The transitional provisions listed in Art. 100 ff. MedDO for the validity of certificates issued under the old legislation (MDD and AIMDD) for medical devices do not apply to new applications for authorisation for inseparable combination products (“integral” and “co-packaged”). Declarations and certificates of conformity according to MDD and AIMDD do not prove conformity with the general safety and performance requirements according to Annex I EU-MDR. For combination products already authorised in Switzerland, the practice according to the Swissmedic publication dated 21 June 2023 applies.
