19 July 2021 – Information for the Industry from Swiss Medtech
Update Guidance for Swiss Distributors and Importers
We have revised the guidance for Swiss Distributors and Importers dated 29 January 2021. You can download the latest version here.
19 July 2021 – Information for the Industry from Swiss Medtech
On 26 May 2021 the European Medical Device Regulation (MDR) will come into force, the same day that the corresponding Swiss Medical Device Ordinance (MedDO) enters into effect. All stakeholders must be aware that the Mutual Recognition Agreement (MRA) between Switzerland and the European Union (EU) will probably not be updated by 26 May 2021. Regardless of all our efforts, Switzerland will probably become a third country in the area of medical devices on 26 May 2021. We offer practical assistance for the third country scenario:
Swiss Distributors and Importers
9 July 2021 – Legal opinion regarding the EU commission notice on 26 may 2021
In our communication from 31 May 2021 (see below), we have informed you about the content of the EU Commission’s Notice to stakeholders on the «Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for Medical Devices». In consultation with Swiss Medtech, Medtech Europe has commissioned the law firm Sidley Austin to clarify the legal basis for this communication. Sidley's memorandum of 2 July 2021 comes to the following conclusions:
- The Commission’s unilateral decision to cease application of the MRA, and the Commission’s purported retrospective withdrawal of mutual recognition for Swiss Legacy Devices, as expressed in particular in the Notice to Stakeholders, are contrary to EU law, the MRA, and WTO law.
- Instead of the position taken in the Notice to Stakeholders, Swiss Legacy Devices must be granted access to the EU market under the same conditions as all other Legacy Devices.
- The EU and its Member States must continue to permit EU sales of all MDD devices with a valid certificate issued by a Swiss conformity assessment body prior to 26 May 2021.
19 June 2021 – Information from Swissmedic about MedDO
Swiss authorised representative (CH-REP)
If the manufacturer of a medical device does not have its registered place of business in Switzerland, its products may only be placed on the market once an authorised representative domiciled in Switzerland has been appointed (Art. 51 para. 1 MedDO). This also applies to manufacturers with their registered place of business in the EU. The transitional periods defined in Art. 104a MedDO apply to the authorised representative.
Here you can find further information on the Swiss authorised representative (CH-REP).
31 May 2021 – EU Commission Notice about MRA
On 26 May 2021, the EU Commission published a statement for stakeholders on the «Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for Medical Devices». They indicated that the mutual recognition and any associated facilitation of trade of medical devices between the EU and Switzerland ceases to apply as of 26 May 2021. The information from the EU Commission included the following points:
- New products under the MDR (incl. class I products): Swiss manufacturers will be treated as any other third country in all respects. In particular, Swiss manufacturers must appoint an authorized representative in the EU.
- Existing certificates issued by a Notified Body based in Switzerland: These certificates will no longer be recognized as valid in the EU.
- Existing certificates issued by Notified Bodies located in the EU: These certificates will continue to be recognized by the EU, provided that the Swiss manufacturer has designated an authorized representative established in the EU.
- Access for foreign manufacturers to the Swiss market: The requirements of the Swiss Medical Devices Ordinance (MepDO, as per 26 May 2021) apply. This includes recognition of all existing certificates and transition periods staggered according to respective risk class (7, 10, 14 months) for the designation of an authorized representative in Switzerland.
The notice concludes with the sentence «Any possible further developments regarding the EU-Switzerland MRA for medical devices will be communicated in due course».
Both the EU and Switzerland mention in their communication that talks are still ongoing.
Swiss Medtech regrets that Switzerland and the EU have not yet agreed on a common interpretation of the current MRA and corresponding transitional provisions for medical devices with existing certificates. The Association will continue to advocate for a swift resolution of this issue.
26 May 2021 – Information from Swissmedic about MedDO
Modification of the Medical Devices Ordinance (MedDO) in the context of pending agreements between Switzerland and the EU.
19 May 2021 – Information from the Federal Council about MedDO
At its meeting today, the Federal Council adopted the amending decree of the totally revised Medical Devices Ordinance. The date of entry into force is 26 May 2021.
12 May 2021 – Information for the Industry from Swiss Medtech
In two weeks – on 26 May 2021 – the new EU Medical Device Regulation (MDR) will come into force. Please take note of the latest information:
Information for the Industry
4 May 2021 – Publications on the Swiss Authorised Representative
Streichenberg & Partner has written three interesting articles in PharmaCircular that provide you with useful information:
Swiss Authorised Representatives: what needs to be considered?
Agreement between Swiss Authorised Representative and manufacturer
End for parallel imports: Is the Swiss healthcare system threatened by supply bottlenecks?
1 April 2021 – Information for the Industry from Swiss Medtech
On behalf of the Federal Council, the Federal Office of Public Health (FOPH) has prepared an amendment to the Medical Devices Ordinance («Contingency MedDO») as a precautionary measure, which will be put into force by the Federal Council on 26 May 2021 if the Mutual Recognition Agreement (MRA) between Switzerland and the European Union (EU) has not been updated by that date. Swiss Medtech is in regular contact with the FOPH regarding the Contingency MedDO. Due to the time pressure under which the Swiss medical technology industry is operating, we would like to inform you about some important contents of the Contingency MedDO. Please note that an update of the MRA before 26 May 2021 is not excluded. In that case, the Contingency MedDO would not enter into force.
3 March 2021 – Open letter of the health actors to the Federal Council
A supply shortage of medical products is becoming apparent. We urge the Federal Council not to create import barriers that would further complicate healthcare for the Swiss population. A self-inflicted supply bottleneck would not be tolerable.
5 February 2021 – Patient care is at risk
Swiss Medtech has drawn the attention of important Swiss healthcare players to the impending supply shortage of medical devices. The worrying situation is still far too little noticed. We appeal to the joint responsibility of all actors in the healthcare sector to pay due attention to the problem and to exert influence with decision-makers in order to avoid negative effects on patient care in Switzerland.Background information (in German)
1 February 2021 – Information for the Industry from Swiss Medtech
We have supplemented the documents for the information of 16 December 2020. You will now find the guidance also in German and French, as well as a 1-pager in the three languages that you can send to your foreign manufacturers.
25 January 2021 – MedTech Europe has updated the IVDR/MDR implementation tracker
This is a very helpful document as it shows you the state of EU documents and provides hyperlinks to directly access them. The document has two separate sections - one for published material and another for documents in the pipeline. We hope this structure helps you navigating throughout the document and get to the information you are looking for.
6 January 2021 – Publication of the expert names
The MDR requires the European Commission to create expert panels to support the scientific assessment and advice in the field of medical devices. Amongst others, the panels of experts will provide an opinion on the notified bodies’ assessments of clinical evaluation of certain high-risk medical devices. The European Commission has published the names of the experts.
16 December 2020 – Information for the Industry from Swiss Medtech
The European Medical Device Regulation (MDR) will come into force in less than six months – on 26 May 2021 – the same day that the corresponding Swiss Medical Device Regulation (MepV) enters into effect. The decision to adapt to the third-country requirements must be made by each company individually. In our function as an industry association, however, we are available to provide advice and support and would like to offer the following assistance:
3 December 2020 – European Commission’s EUDAMED database
The European Commission’s EUDAMED database, a critical component of the MDR, was launched with the actor registration module. At present, economic operators established in the EU or European authorized representatives may register. Economic operators based in Switzerland will NOT be able to register until an agreement between Switzerland and the EU can be reached.
19 November 2020 – Harmonised standards under MDR
A request for harmonisation of standards was submitted to the European Commission for adoption and submission to the European Committee for Standardization and the European Committee for Electrotechnical Standardization (CEN/CENELEC). Annex I contains a list of 151 existing and 28 new standards with deadlines for their adoption.
16 November 2020 – «Language implications of MDR for labelling of Medical Devices»
Medtech Europa has updated the overview of the «Language implications of MDR for labelling of Medical Devices».
7 October 2020 – Manufacturers of Class I medical devices
To help manufacturers of Class I medical devices comply with MDR, the Irish HPRA has compiled a crystal-clear list of key activities to complete. For each activity, the document refers to the relevant articles in the legislation.
13 July 2020 – Call for Action regarding «Virtual Audits»
Now is the right time to allow virtual audits – otherwise the time gained from the MDR postponement is wasted.
15 May 2020 – Information for the Industry from Swiss Medtech
Due to the postponement of the MDR start date to 26 May 2021, the Swiss Medtch guidelines were updated.
24 April 2020 – MDR postponement comes into force
The amendment to the Ordinance on Medical Devices (MDR) has now been published in the Official Journal of the European Union and comes into force immediately.
You can view the text here.
17 April 2020 – Information for the Industry from Swiss Medtech
EU Parliament postpones date of application of the MDR to 26 May 2021. Swiss Medtech informs the Swiss medical technology industry about the consequences.
20 January 2020 – Information for the Industry from Swiss Medtech
Update regarding the Institutional Agreement and the Mutual Recognition Agreement.
5 November 2019 – Information of the EU Commission to EUDAMED
EU Commission officially announces a two-year delay in the introduction of Eudamed.
25 April 2019 – Information for the Industry from Swiss Medtech
Swiss Medtech recommendations to Swiss medical device manufacturers: prepare for the scenario of having to meet the requirements of a third country.