Implementation of the new medical devices regulations

COVID-19 pandemic: European Commission postponing introduction of the MDR by one year

07.05.2020 (Updated)

In May 2017, the EU introduced more stringent requirements for medical devices and in-vitro diagnostics throughout Europe. Since Switzerland is integrated into the internal European market for medical devices, Swiss law was adapted so as to maintain equivalence.  

The amendments to the Therapeutic Products Act (TPA) and Human Research Act (HRA) ratified by the Swiss parliament on 22 March 2019 should originally have entered into force on 26 May 2020 along with the associated ordinances.

In connection with the COVID-19 pandemic, the European Commission announced on 25 March 2020 that the full implementation of the MDR would be deferred by one year. This proposal was adopted by the EU Parliament on 17 April 2020 and by the EU Council on 22 April 2020.

Switzerland’s continued aim is to achieve equivalence with EU legislation, and it will therefore also defer the entry into force of the revised Swiss medical device legislation by one year, to 26 May 2021. Not affected by the postponement is the In Vitro Diagnostics Regulation (IVDR).


Context

On 25 May 2017 the Commission of the European Union introduced two new Medical Devices Regulations into law. Regulations (EU) 2017/745 on medical devices (MDR) and 2017/746 on in vitro diagnostic medical devices (IVDR) will replace the existing regulations dating from the 1990s. As of May 2024 at the latest, it will only be legally permissible to place products with CE marks on the market. Different transition periods will apply for different product classes.

The new medical devices regulations improve patient safety and transparency, while imposing stricter rules on all parties:

  • The criteria for the authorisation and supervision of clinical trials and performance testing have been tightened. For all products, manufacturers will have to undertake more detailed clinical evaluations than hitherto, often conducting their own clinical trials.
  • For market access, more devices than hitherto will have to be examined by a notified conformity assessment body (NB). In addition, for certain high-risk devices the conformity assessment will be checked by independent experts.
  • Both the NBs and the national authorities that supervise them will be subject to stricter requirements.
  • Market supervision by government bodies and cooperation with the European authorities will be extended.
  • All medical devices will be given a Unique Device Identification (UDI) to ensure traceability.
  • Greater obligations will be imposed on all the market players (authorised representatives, importers, distributors), who will also be more closely integrated into the supervisory process. Manufacturers will be required to produce regular safety reports on their products.
  • Transparency will be increased: data on the devices’ performance and safety will also be made publicly accessible through a new, centralised European Database on Medical Devices (EUDAMED 3). Moreover, patients will in future be issued with an “implant card”.

Swissmedic is active in numerous European working groups aimed at ensuring equivalent implementation in Switzerland.

European Database on Medical Devices (EUDAMED 3)
Users and patients are to be given access to technical product documentation and safety data via the European Database on Medical Devices (EUDAMED 3). Identification and traceability enhance the level of information regarding medical devices, thus also benefiting patients.

Originally the plan was for EUDAMED 3 to be completed by 2022 after having been made available in phases beginning in 2020. At the end of 2019, the EU Commission announced that introduction was being delayed by two years. The signatory states and European bodies are currently establishing the extent to which it might still be possible to start phasing in the database and what impact this will have on implementation of the new regulations. Swissmedic is taking part in the investigations and will provide information as soon as decisions have been made.

Revision of the implementing legislation
Switzerland is revising its medical devices legislation in close alignment to the new and more stringent EU rules. Based on the amendments to the Therapeutic Products Act (TPA) and the Human Research Act (HRA) ratified by Parliament on 22 March 2019, the Medical Devices Ordinance (MedDO) was completely revised and a new ordinance on clinical studies for medical devices was drafted. A new ordinance on in-vitro diagnostics is to follow in 2022.

The public consultation procedure has now been completed. The plan is for the revised Medical Devices Ordinance (MedDO) and the new ordinance on clinical studies for medical devices to pass into law at the same time as the EU legislation so as to align Swiss legislation with its European counterpart. The affected agencies are now investigating the precise modalities of the postponement and what consequences it will have for the ongoing process of revising Swiss medical devices legislation and for the MRA.

Responsibility for the revision of Swiss medical devices law lies with the FOPH.

Updating of the MRA (Mutual Recognition Agreement) in the area of medical devices
Market access, coordinated market supervision, exchange of information and mutual recognition of conformity assessments are based on the Mutual Recognition Agreement (MRA) that forms part of the Bilateral I agreements. Renewed revision of the MRA on the medical devices section of the bilateral agreements, which was last revised at the end of 2017, is a precondition for the full implementation of the new medical devices regulations.

Parallel to the actual legislative projects, the MRA will also have to be amended via negotiations in the Switzerland–EU Joint Committee so that the mutual obligations can be enshrined in international law. SECO is lead managing this process.

Last modification 07.04.2020

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