This month’s round up covers the latest on Swiss Medtech’s import concerns in relation to Switzerland’s third country status, updated regulations and resources from the EU concerning MDR & IVDR, a new FDA draft guidance and discussion paper, and a playbook on threat modelling from the MITRE Corporation. Read on for more…
Swiss Medtech shares import concerns with FOPH & Swissmedic
In our October MedTech news update we reported on Swiss Medtech’s call for urgent changes to the national Medical Devices Ordinance to address import concerns triggered by Switzerland’s downgrading to third country status.
Swiss Medtech representatives recently met with the Directorate of the Federal Office of Public Health (FOPH) and the Directorate of the supervisory authority Swissmedic to further explain their grave concerns regarding the imminent shortfalls in medical device supply.
According to Swiss Medtech, the authorities have communicated their position, and as they see it:
- There is no legal uncertainty for the MedTech sector
- The Mutual Recognition Agreement (MRA) between Switzerland and the EU is no longer applicable
- Legal basis exists to require relabelling of medical devices approved under the old law (MDD products)
- There is no reason to remove existing import barriers as a precautionary measure to ensure availability of medical devices
For more on this topic, see here.
EU Commission sets rules for applying MDR to EUDAMED
Commission Implementing Regulation (EU) 2021/2078 lays down rules for the application of Regulation (EU) 2017/745 (MDR) with regards to the European Database on Medical Devices (EUDAMED). The regulation, which took effect from 19 December this year, covers EUDAMED set up, maintenance, accessibility, and cybersecurity. Find out more here.
MDCG releases template for substantial modification of clinical investigation under MDR
As the industry awaits EUDAMED’s completion, the MDCG has been creating a series of clinical investigation application/notification documents to support clinical investigation procedures with respect to MDR (e.g. MDCG 2021-08 and MDCG 2021-20).
MDCG 2021-28 adds to the document series, providing a template for the substantial modification of clinical investigations under MDR. Whilst it’s likely that this template will be withdrawn once the EUDAMED module for clinical investigations is fully functional, until then, the template is intended to be facilitative – including the same data fields as the EUDAMED system in development insofar as possible.
Its use by Competent Authorities and sponsors is encouraged, however the MDCG also notes that it’s important to check any specific national requirements with the individual Member States in which your clinical investigation is planned to take place. Read more and access the template here.
MDCG releases Q&A on Articles 13 & 14 of MDR & IVDR
MDCG 2021-27 presents questions and answers on requirements related to importers and distributors under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
The questions covered by the document aim to provide further detail on the operational and practical implementation of Articles 13 and 14 as well as other related obligations for importers and distributors under these Regulations. Read the Q&A here.
FDA issues draft guidance on referencing “device” and “counterfeit device”
“Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents“ aims to offer guidance regarding references to the terms “device” and “counterfeit device.”
Whilst the contents of the guidance do not have the force and effect of law, in light of recent amendments to section 201(h) of the FD&C Act (due to the enactment of the Safeguarding Therapeutics Act), the document is intended to provide clarity to the public regarding existing requirements under the law. You can access the draft guidance here.
FDA seeks public input on 3D printing of medical devices at PoC
On 10 December the FDA published a discussion paper regarding 3D printing medical devices at the point of care (PoC). The document’s purpose is to gather the public’s feedback to inform future policy development.
The paper provides relevant background as well as an overview of FDA regulation of devices and 3D printing. It also outlines how capabilities at a 3D printing facility factor into device safety and effectiveness, and identifies the potential challenges presented by medical devices that are 3D printed at PoC locations such as hospitals and doctor’s offices.
Now open for public comments, you can access the discussion paper here.
Threat modelling medical devices: A playbook from the MITRE Corporation
To increase knowledge and understanding of threat modelling throughout the medical device ecosystem and in turn strengthen the cybersecurity and safety of medical devices, FDA has previously collaborated with MITRE, the Medical Device Innovation Consortium (MDIC), and Adam Shostack to conduct a series of threat modelling bootcamps.
Based on the learnings from these bootcamps, the MITRE Corporation has now published a “Playbook for Threat Modelling Medical Devices” that provides a foundation to inform an organisation’s threat modelling practices.
Focussing on general threat modelling principles, the playbook provides insights on how an organisation can systematically and consistently develop or evolve an approach to creating threat models to achieve their objectives. You can access the playbook here.
That concludes our December MedTech news – our final news update for 2021. Check back in the new year for our first round up of 2022, and in the meantime, we wish you a safe and restful festive season.
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