This month’s MedTech news includes guidance from the MDCG on significant changes under IVDR, new ordinances from the Swiss Federal Council, updates from the EU Commission on harmonised standards and delegated acts under MDR & IVDR, as well as new information from Swiss Medtech and draft guidance from the FDA. Read on for more.
MDCG releases guidance on significant changes regarding transitional provision under IVDR
The MDCG has released guidance that clarifies the concept of “significant changes in the design and intended purpose” under IVDR Article 110(3). MDCG 2022-6 concerns manufacturers of devices that are compliant with the IVDD and placed on the market after 26 May 2022 during the IVDR transition period, irrespective of whether those devices required notified body involvement under the IVDD. You can read the guidance document here.
Swiss Federal Council publishes IvDO
As reported earlier this month, 4 May saw the Federal Council publish two ordinances for IVDs in Switzerland. Effective from 26 May 2022, the new Ordinance on In-Vitro Diagnostics (IvDO) and an amendment to the Ordinance on Clinical Trials with Medical Devices (KlinV-Mep) form the final stage of Swiss medical device legislation alignment with the EU IVDR.
Due to the lack of agreement between Switzerland and the EU on an updated mutual recognition of conformity assessments for medical devices, certain requirements must be met twice to cover the Swiss and EU markets. To adapt to this situation, as per the IVDR, the IvDO provides transition periods for IVDs with a certificate granted under the previous framework, as well as for IVDs subject to a conformity assessment under the new ordinance.
It also outlines transition periods for manufacturers established in the EU/EEA and those with an EU / EEA located Authorized Representative, to appoint a Swiss Authorized Representative:
- 31 December 2022 for Class D IVDs
- 31 March 2023 for Class B & C IVDs
- 31 July 2023 for Class A IVDs
EU Commission publishes new harmonised standards
The EU Commission has published new harmonised standards under the medical devices Regulations. The following publications in the Official Journal of the European Union (OJEU) of references are now available:
- For Regulation (EU) 2017/745 on medical devices: Commission Implementing Decision (EU) 2022/757 of 11 May 2022
- For Regulation (EU) 2017/746 on in vitro diagnostic medical devices: Commission Implementing Decision (EU) 2022/729 of 11 May 2022
For more information on harmonised standards under the medical devices Regulations, click here.
Swiss Medtech clarifies when a medical device is considered “placed on the market”
Swiss Medtech has commissioned a legal opinion regarding the meaning of the term “placing on the market” to reduce uncertainty and avoid interpretations that can negatively impact patient care in Switzerland.
The organisation has concluded that whilst there is some room for interpretation, they are aligned with Medtech Europe on this matter, agreeing that a medical device that is marketable on the EU or Swiss market is deemed to have been “placed on the market” if it has been imported into Switzerland by a Swiss distributor (who thereby becomes an importer). Read more on this topic here.
EU Commission adopts delegated acts under MDR & IVDR
The EU MDR and IVDR empower the EU Commission to adopt several delegated acts. The recently adopted delegated acts involve:
- Products without an intended medical purpose
- Amendment of the definition of ‘nanomaterial’ and related definitions
- Elements to be included in the Technical Documentation (TD), and TD on post-market surveillance
- Exemption from the requirement of an implant card
- Minimum content of the EU declaration of conformity
- Information to be submitted as part of the UDI system
- Frequency of complete re-assessment of notified bodies
- Exemption of certain well-established technologies from assessment of TD for every single device
- Minimum content of certificates issued by a notified body
- Exemption of certain well-established technologies from assessment of TD for every single device and from the requirement to perform clinical investigations
- Documentation regarding the application for clinical investigation and interventional clinical performance studies
- Tasks of expert panels and expert laboratories
Find out more about the delegated acts here.
Swiss Medtech shares vision to strengthen MedTech industry in Switzerland
On 17 May Swiss Medtech presented its vision for “MedTech in Switzerland 2030”, outlining strategies to permanently strengthen Switzerland’s attractiveness as a MedTech business location.
The agenda of reforms included stable trade relations, open markets, promotion of innovation, and reimbursement models adapted for the MedTech industry. With Switzerland’s industry competitiveness weakened by the breakdown of institutional agreement negotiations with the EU, Swiss Medtech’s improvement plan is both timely and important. Find out more here.
FDA issues draft guidance on Voluntary Improvement Program participation
The FDA’s CDRH has issued draft guidance that describes its policy regarding the FDA’s participation in the Voluntary Improvement Program (VIP).
Facilitated by the Medical Device Innovation Consortium (MDIC) – that evaluates the capability and performance of a medical device manufacturer’s practices using third-party appraisals, the VIP is intended to guide improvement measures that ultimately enhance device quality. Find out more here.
That concludes our May MedTech news. Check back in June for more updates.
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