7 November 2023 – Position paper from MedTech Europe on the Future of the MDR/IVDR
The position paper follows the letter sent in September to the European Commissioner for Health (see 19 September 2023). It provides explanation of the issues, principles for success and examples for possible solutions. It should serve as a basis for discussions with stakeholders and policymakers on the much needed reform of the EU medical technology regulatory framework.
27 October 2023 – Information for the industry from Swiss Medtech
We have revised the contract templates for CH-REPs following feedback from Swissmedic inspections. They are now available in version 04.
Order contract template for CH-REPs
24 October 2023 – Information from the EU commission
The European Commission DG SANTE has announced revised and delayed timelines for the availability of EUDAMED, the European Database on Medical Devices. The new target date for EUDAMED full functionality is Q2/2027 as a best case scenario.
29 September 2023 – Information of the Federal Council
The Federal Council has decided to extend the transitional periods for the certification of medical devices in accordance with the corresponding EU regulation under certain conditions. At its meeting on 29 September 2023, the Federal Council adopted the necessary amendments to the Medical Devices Ordinance (MepV) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDV). These amendments will enter into force on 1 November 2023.
19 September 2023 – Open Letter from MedTech Europe on the Future of the MDR/IVDR
On 14th Sept. MedTech Europe has sent an Open Letter to European Commissioner for Health, Stella Kyriakides, asking for comprehensive structural reforms to address healthcare access challenges resulting from the MDR and IVDR. The letter was co-signed by 34 national associations (including Swiss Medtech). The key asks include:
- a more efficient and fit-for-purpose CE marking system (efficiency)
- a system that supports innovation for medical devices and diagnostics (innovation)
- a single, dedicated accountable structure to oversee and manage the regulatory system (governance)
29 August 2023 – Information from BVMed and VDGH
19 July 2023 – Information from the EU Commission
The EU Commission has published a very helpful Q&A document on the extension of the MDR transitional period. It includes links to important additional documents:
- The Manufacturer’s Declaration template (Footnote 7)
- The Notified Bodies’ Confirmation Letter template (Footnote 8)
- The Factsheet for authorities in non-EU/EEA states (Footnote 9)
16 June 2023 – Information from GOV.UK
The UK has updated its guidance on the new medical device regulations. The recognition of medical devices with CE marking will be extended well beyond 30 June 2023. Medical devices with a valid MDD/AIMDD declaration can be placed on the market until 30 June 2028, MDR compliant devices and all IVDs until 30 June 2030.
9 May 2023 – Information from Team-NB
Team-NB has published a position paper to harmonise the technical documentation submissions from manufacturers. This best practice document has been developed by members of Team-NB based on the guidance documents of individual notified bodies to develop a unified approach for the submission of technical documentation.
31 March 2023 – Information from Swissmedic
During the transitional phase, until the Medical Devices Ordinance (MedDO) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO) are amended, Swissmedic is already going ahead with enforcement according to the EU amendment 2023/607.
28 March 2023 – Information from Swissmedic
Poor marks for manufacturers of Class I products
Between August and December 2022, Swissmedic reviewed declarations of compliance from a random sample of 27 (equivalent to 8% of) Swiss manufacturers of Class I medical devices. Findings showed that 14% of manufacturers examined were not registered with Swissmedic, 39% of the verified Class I medical devices were not correctly notified to Swissmedic, 11% of the manufacturers were unable to demonstrate compliance with the new legal requirements, and 70% of reviewed post-market surveillance (PMS) documentation also did not meet legal requirements. Swiss Medtech calls on all manufacturers of Class I medical devices to assess their compliance with the legal requirements and to correct any outstanding issues without delay.
20 March 2023 – MDR amendments are now legally binding
Regulation (EU) 2023/607 of 15 March 2023 was published today in the Official Journal of the EU and enters into force with immediate effect. The final signed text is available in all EU languages and can be found here.
6 January 2023 – EU Commission proposal
More time to certify medical devices under MDR
On 6th January, the EU Commission adopted the proposal (EU) 2023/0005 to give more time to certify medical devices to mitigate the risk of shortages. The proposal will extend the validity of MDD-certificates (issued up to 26 May 2021) and introduce a longer transition period to adapt to new rules under the MDR. The extension will be subject to certain conditions, so that only devices that are safe and for which manufacturers have already taken steps to transition to the MDR rules will benefit from the additional time.
Key elements of the proposal:
- For medical devices of medium and lower risk (class Ix and II, except IIb implantable), the transition period shall be extended from 26 May 2024 to 31 December 2028.
- For medical devices of higher risk (class IIb implantablle and III), the transition period shall be extended from 26 May 2024 to 31 December 2027.
- For class III implantable custom-made devices, a transition period until 26 May 2026 is proposed.
- The Commission proposes to remove the «sell-off» date currently established in the MDR and IVDR.
The proposal will now be negotiated by the European Parliament and the Council.
17 November 2022 – Press release from SECO
Agreement with the United Kingdom on mutual recognition of conformity assessments
On 17 November, Switzerland and the United Kingdom signed an agreement on the mutual recognition of conformity assessments. This means that in certain sectors, product testing by a UK conformity assessment body is no longer required for exports from Switzerland to the UK. The agreement will be provisionally applied from 1 January 2023 and will enter into force no later than 28 February 2023. It was approved by the Federal Council on 16 November.
30 August 2022 – MDCG position paper regarding transition to MDR/IVDR
The Medical Devices Coordination Group (MDCG) has published an interesting position paper (MDCG 2022-14) outlining its position on a smooth transition aimed at avoiding disruptions in the supply of medical devices and ensuring access to the European market for innovative medical devices. The highlighted passages might help you in communicating with your notified body.
9 August 2022 – Position paper on MDCG documents
The Medical Devices Coordination Group (MDCG) uses guidance documents to assist stakeholders in implementing the medical devices regulations. With this paper MedTech Europe provides its view on how guidance documents should be used in a way that does not disrupt manufacturers’ efforts to transition to the new rules of the MDR and IVDR. MedTech Europe will now share the paper with the European Commission, the MDCG, the CAMD and the Notified Bodies.
21 July 2022 – New EUDAMED information center launched
The European Commission has launched the new EUDAMED Information Center. It consolidates all EUDAMED Production User Guides, provides quick and structured access to all pertinent information and includes a contact form for users to reach the EUDAMED Support Team.
20 July 2022 – MedTech Europe Survey Report on MDR implementation
MedTech Europe conducted a survey with 475 responses across large companies and SMEs to quantify the availability of medical devices. The results show that less than 15% of medical devices have already received MDR certificates. Time-to-certification has doubled to 13-18 months and more than 15% of SMEs still have no access a MDR-designated Notified Body. As a result, nearly half of the respondants say they will deprioritise the EU market for first regulatory approval of new devices.
29 April 2022 – Information from Swiss Medtech on placing on the market
When is a medical device considered «placed on the market» in Switzerland? The term «placing on the market» is interpreted in different ways (see below), which leads to great uncertainty. Depending on which interpretation is applied, negative consequences for patient care in Switzerland are possible. Swiss Medtech has commissioned a legal opinion on the interpretation of the term «placing on the market».
17 March 2022 – Information from Swiss Medtech on direct import
We have written a guide for Swiss professionals and healthcare institutions on the direct procurement of foreign medical devices. You can download the guide here:
9 March 2022 – Paper on the impending supply deficit
The article (in German) published in «Life Science Recht» describes the causes of possible supply deficits for medical devices in Switzerland and outlines possible solutions to prevent a supply crisis.
Article «Life Science Recht» (in German)
25 January 2022 – Information from Swiss Medtech on SQS Certificates
Germany recognises SQS certificates
On 26 May 2021, the EU Commission published information to stakeholders on the «Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for Medical Devices». Among other things, it stated that the EU would no longer recognise existing certificates issued by a notified body based in Switzerland – i.e. products with an SQS certificate (see information dated 31 May 2021).
Swiss Medtech supports the position of the Federal Council, according to which the MRA is still valid and applicable. The position of the EU Commission therefore violates existing law (see information dated 9 July 2021). With regard to the SQS certificates, the association therefore initiated two actions:
- Swiss Medtech has provided a platform for the 54 Swiss manufacturers with SQS certificates to exchange information and join forces. Eight of the manufacturers concerned – represented by the law firm Sidley Austin LLP – filed a complaint with the General Court of the European Union on 8 December 2021.
- Swiss Medtech has attempted to influence the market surveillance authorities of other EU states via their national medtech associations. The aim was for individual EU states to oppose the EU Commission's ban on SQS. In Germany, these efforts have led to success: The German medtech associations BAH, BPI, BVMed, MedicalMountains, Spectaris, VDDI and VDGH had already jointly written to the AGMP (Working Group on Medical Devices of the Supreme State Health Authorities) on 9 July 2021. Their response arrived on 20 January: The certificates of Swiss bodies notified under Directives 90/385/EEC and 93/42/EEC will continue to be valid until the deadlines set out in Article 120(2) MDR. Swiss manufacturers may therefore continue to sell their MDD products with SQS certificates in Germany, provided they have appointed an EC-REP for these products.
We thank our colleagues in the DACH region for their great support.
20 January 2022 – Information for the Industry from Swiss Medtech
We have revised the guidance for Swiss distributors and importers of 19 July 2021 and the contract template for the designation of a Swiss Authorised Representative (CH-REP) of 28 June 2021. You can download the latest version of the guidance:
19 January 2022 – Information from Swissmedic on direct import
Swissmedic has supplemented its information sheet «Procurement of medical devices in healthcare institutions». It now contains the following statement in Chapter 7: «For the reasons already stated, healthcare professionals and institutions should usually procure products from a Swiss manufacturer or that have a Swiss authorised representative and only directly use products from abroad without a Swiss authorised representative in justified exceptional cases.»
30 December 2021 – Information for the Industry from Swiss Medtech
On 17 December 2021, we informed you that Swiss Medtech was working with unwavering commitment in the interests of the Swiss medical technology industry and patient care, on a more pragmatic solution for the labelling of medical devices. We are pleased to inform you that the Association has reached an agreement with the FOPH (BAG) and Swissmedic authorities. The Medical Devices Ordinance (MepV) Enforcement Practices have also been adapted accordingly.
17 December 2021 – Information for the industry from Swiss Medtech
The Federal Council has confirmed its position that – from Switzerland's point of view – the MRA remains applicable. It can be noted that the conduct of the health authorities contradicts the official position of the Swiss government. A Legal Opinion commissioned by Swiss Medtech concludes that the Swissmedic «Obligations for Economic Operators CH» (German original: Pflichten Wirtschaftsakteure CH) information sheet contains no legal basis which would require labelling to include the Swiss authorised representative for products subject to the old legislation (MDD products).
30 November 2021 – Information for the industry from Swiss Medtech
On 16 November, Swiss Medtech representatives met in person with the Directorate of the Federal Office of Public Health (FOPH / BAG) and the Directorate of the supervisory authority Swissmedic to further explain requests it had submitted (22 September, in writing) in connection with the Medical Devices Ordinance (MepV), as well as its grave concern about the imminent shortfalls in supply. Unfortunately, the outcome of the talks was not satisfactory. The authorities have rejected all of the association's demands.
19 August 2021 – Information from Swissmedic about MedDO
Information on the import: On 10 August 2021, Swissmedic published a information sheet on the obligations of Swiss economic operators. This was done with the aim of answering as many of the industry's open questions on the implementation of the Medical Devices Ordinance (MDO) as possible in a timely manner. This leaflet provides economic operators (authorised representatives, importers and distributors) with an overview of the requirements of the revised MDO that are relevant to them. In addition to the obligations, terminology is explained, transitional provisions are set out and it is shown which information must be indicated on a product.
Information sheet: Obligations for authorised representatives, importers and distributors (swissmedic.ch)
Not covered by this information sheet are, among other things, the registration of products, parallel imports, combination products and the duties of the responsible person (PRRC). Swiss Medtech will also push for rapid clarification of the regulatory uncertainties in these areas.
12 August 2021 – Information from MedTech Europe
MedTech Europe has issued an official document addressing the question of «Accessing the EU market under the transitional provisions of Article 120 of the MDR». This document shall support discussions on questions arising from the current situation with respect to EU – Switzerland MRA.
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
- 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
- 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.
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.
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.
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.