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 that 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? Revised August 2025
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 corresponding proof can be provided by submitting declarations of conformity and certificates according to EU-MDR (CE proof of conformity) or a NBOp as an alternative option for inseparable combination products.
If no current CE certificates of conformity issued under EU-MDR are available at the time the application is submitted, CE certificates of conformity issued under the old Directives can be submitted as an alternative. This is subject to the condition that suitable additional evidence is provided proving that the requirements applicable to the Validity of certificates issued under the old legislation for medical devices are fulfilled by analogy to the provisions of MedDO.
These include:
- The medical device component has not undergone any significant changes in design or intended purpose.
- The manufacturer of the medical device component has established a quality management system in accordance with Art. 10 para. 9 EU MDR by 26 May 2024 at the latest.
- The manufacturer of the medical device component has signed a written agreement in accordance with Annex VII section 4.3 subparagraph 2 EU MDR (conformity assessment according to EU-MDR) with a designated/notified body no later than 26 September 2024.
The marketing authorisation holder must confirm compliance with these requirements to Swissmedic in the letter accompanying the submission. It may make reference to the following items of evidence:
- A self-declaration by the manufacturer confirming that the conditions for placing devices that comply with the old legislation on the market are met (see template from the EU industry association).
- A confirmation letter issued by the designated/notified body stating that the manufacturer has signed with it a written agreement for a conformity assessment procedure under EU MDR by 26 September 2024 at the latest (see Team-NB template).
As soon as the marketing authorisation holders have received the certificates of conformity in accordance with EU-MDR, they must submit them together with another quality variation as an editorial change (see Guidance document Formal Requirements (PDF, 1 MB, 01.09.2025)) or as a B.IV.1.z, type IA, variation.
