This month’s round up covers news from the European Parliament regarding IVDR, a notice for 3rd country IVD manufacturers from the MDCG, an update on Swiss Medtech’s labelling solution to tackle product supply problems, plus guidance and more from the FDA and Health Canada. Read on for more…
EU & Switzerland
European Parliament adopts progressive IVDR roll-out
Following adoption by the European Parliament and the Council, the In Vitro Diagnostic Medical Devices Regulation that will apply from 26 May 2022 can now be progressively rolled out.
In October last year the EU commission proposed a progressive roll-out of the IVDR to prevent the disruption of essential healthcare products caused by delays due to COVID-19. The adoption of this proposal by the co-legislators will keep the supply of these products flowing.
Whilst the amending Regulation does not change any requirements of the original 2017 IVDR, it does change the dates of application regarding some of these requirements for certain medical devices:
- For higher risk Class D devices such as HIV or hepatitis tests, the new requirements will apply from May 2025
- For lower risk Class C devices, e.g. certain influenza tests, the date of application is extended to May 2026
- For lower risk Class B and A sterile devices the application starts in May 2027
For more information on this announcement, click here.
MDCG publishes notice for 3rd country manufacturers of SARS-CoV-2 IVDs
The MDCG’s recent notice aims to highlight several common issues identified by EU national competent authorities during their market surveillance regarding the compliance of SARS-CoV-2 IVDs with Directive 98/79/EC.
The issues identified are also thought to be relevant for some SARS-CoV-2 devices which are transitioning to comply with the IVDR.
MDCG 2022-1 is addressed to manufacturers of in vitro diagnostic medical devices (IVDs) that detect and/or quantify markers of SARS-CoV-2 infection, who are based outside of the EU / EEA and intend to place their devices on the EU market. Access the notice and read more here.
Swiss Medtech shares labelling solution to tackle supply problems
Last month, Swiss Medtech announced their commitment to finding a pragmatic solution regarding the labelling of medicinal products being imported into Switzerland under MDD/AIMD and MDR.
At the end of December, the association delivered on their goal, and together with BAG and Swissmedic, found a solution which aims to help defuse the emerging medical device supply problems.
Take a look at this short article to find out how the solution affects the listing of Swiss authorised representatives (CH-REP) and importers on MDD/AIMD & MDR products of all classes, and to read the recommended action to take.
US & Canada
FDA guidance: Digital Health Tech for Remote Data Acquisition in Clinical Investigations
The FDA has published draft guidance that provides recommendations on the use of digital health technologies (DHTs) to acquire data remotely from participants in clinical investigations evaluating medical products.
Taking the form of hardware and/or software, DHTs may be used to gather health-related information from study participants and transmit that information to study investigators / other authorised parties to evaluate the safety and effectiveness of medical products. You can read the draft guidance here, and submit comments until 22 March 2022.
FDA’s CDRH releases Health of Women Program Strategic Plan
To recognise the importance of addressing sex and gender specific issues in MedTech design, development, and implementation, the FDA’s CDRH has formally created the Health of Women Program.
Envisioning a ground-breaking initiative to explore the unique issues related to the performance of medical devices in women across their lifetime, the program encompasses health conditions that are specific, more common, or more serious in females, as well as conditions that have distinct causes / manifestations, different outcomes / treatment and higher morbidity or mortality rates in women.
The CDRH has released a strategic plan which outlines the program’s aims and priorities. Find out more and read the plan here.
FDA expands reporting requirements for manufacturing discontinuance or interruption
The FDA has issued guidance that requires manufacturers to notify them of any permanent discontinuances or interruptions in the manufacture of certain medical devices that is likely to lead to a meaningful disruption in the supply of that device in the US.
The guidance means to assist manufacturers in providing timely, informative notifications about changes in the production of certain medical devices to help mitigate device shortages during / in advance of a public health emergency.
By issuing this guidance, the FDA implements amendments to the FD&C Act made by the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The guidance, which is open for comments until 11 March 2022, is available to read here.
FDA guidance: Assessing the credibility of CM&S in medical device submissions
In this recent draft guidance document, the FDA provides their recommendations on a risk-based framework that can be utilised to assess the credibility of computational modelling and simulation (CM&S) used in regulatory submissions for medical devices.
Applying to physics-based, mechanistic, and other first principles-based models, the recommendations in the document aim to promote consistency and facilitate efficient review of medical device submissions. You can read the guidance here, and submit comments until 22 February 2022.
Health Canada proposes regulatory amendments to Medical Device Regulations
Health Canada has proposed regulatory amendments to the Canadian Medical Device Regulations that are intended to deliver on commitments outlined in the Health and Biosciences Regulatory Review regarding the modernisation of compliance and enforcement oversight.
The proposed amendments for medical devices would streamline MDEL application requirements to reflect current practices, provide the Minister of Health with new and expanded authorities over MDELs, and implement ministerial authority regarding recalls of medical devices. Find out more about the proposed amendments here.
That concludes our January MedTech news. Check back in February for more updates.
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