Regulatory Focus™ > News Articles > 2021 > 9 > Euro Roundup: MedTech Europe warns 75% of diagnostics may lack IVDR certification by deadline

Euro Roundup: MedTech Europe warns 75% of diagnostics may lack IVDR certification by deadline

Posted 16 September 2021 | By Nick Paul Taylor 

Euro Roundup: MedTech Europe warns 75% of diagnostics may lack IVDR certification by deadline

MedTech Europe has estimated as few as one-quarter of currently available in vitro diagnostics (IVDs) will be certified under the incoming regulations by the time they take effect next year. The trade group based its forecast on a survey of IVD manufacturers.
 
Many IVDs will need to be certified by notified bodies for the first time under the new regulations. With a small pool of notified bodies available to do the work, MedTech Europe has repeatedly raised concerns that IVD manufacturers will be unable to get the required paperwork by the time the rules take effect in May 2022.
 
MedTech Europe now forecasts that 22% of IVDs will unavoidably be lost in the transition to IVDR. A further 17% of IVDs will definitely not be certified in time. MedTech Europe calculates 24% of IVDs will either have an IVDR certificate or be allowed on the market based on self-certification because they are low risk.
 
That leaves 37% of IVDs with uncertain futures. Depending on what happens in the coming months, MedTech Europe forecasts that as few as 24% or as many as 61% of IVDs may be certified by the time the law takes effect.
 
Notified body capacity is a barrier to hitting the upper end of the range. The survey found 53% of IVD manufacturers, and 64% of small and medium-sized enterprises, cannot sign with a notified body to certify their IVDs and quality management systems. MedTech Europe is calling for urgent action to ensure “that a minimum viable infrastructure is in place.”
 
Survey Results
 
Swissmedic identifies challenges of running decentralized clinical trials
 
The Swiss Agency for Therapeutic Products (Swissmedic) has set out the challenges of decentralized clinical trials (DCTs) and the conditions under which they must be run in a position paper. Swissmedic wants researchers to liaise closely with it and ethics committees before starting DCTs.
 
Interest in running decentralized and hybrid clinical trials rose as the pandemic made it harder or impossible to engage in face-to-face interactions. Swissmedic discussed the topic at an event before the pandemic began, emerging with evidence that DCTs can better integrate into the day-to-day routines of subjects, improve data quality and unlock opportunities to study rare diseases. However, Swissmedic also sees challenges to the effective, compliant conduct of DCTs.
 
One fundamental issue relates to the legal status of DCTs. History shows Swiss law is flexible enough to support the use of new technologies without requiring legislative changes. Yet, it is also possible that “areas of risk are likely to be identified which require modification of the law, perhaps even before a situation in which DCTs can be approved has been reached,” Swissmedic wrote. The agency is unable to say if legislative changes are needed at this time.
 
Swissmedic identified more specific challenges related to protecting subjects, investigational product logistics, and data integrity and protection. As DCTs eliminate in-person interaction, Swissmedic sees a risk that “the personal relationship with the physician, which is the basis of mutual trust, cannot be established.” Equally, the agency is concerned that reliance on technology to collect data remotely will skew the study population toward “technically versed individuals.”
 
The rest of the guide goes deeper into certain DCT processes, such as recruitment through digital channels and remote data capture. In each area, Swissmedic sets out how the processes are carried out in DCTs and highlights parts of existing legislation and regulation that apply to the procedures.
 
Swissmedic Notice
 
Ireland proposes 25% price hike for clinical trial ethics committee filings
 
Ireland is planning to raise the fees for certain clinical trial filings to the National Office for Research Ethics Committees by 25%. The proposals are part of a broader set of changes intended to cover the costs of the incoming European Union Clinical Trial Regulation (CTR).
 
Once CTR takes effect early next year, sponsors will pay a single fee to Ireland’s Health Products Regulatory Authority (HPRA) that covers the regulatory and ethics aspects of their submissions. HPRA will transfer a portion of the fee to the National Office to pay for the research ethics review. The two Irish bodies set out what that will mean for sponsors in a public consultation on the proposed fees for 2022.
 
The proposal features new fees and increases to existing charges. Sponsors that file to run a clinical trial that only has sites in Ireland will pay €300 ($350) more to HPRA and 25% more to the National Office. New fees of between €5,500 and €6,700 to HPRA and €1,250 to the National Office apply to filings to run multinational clinical trials for which Ireland is the reporting member state.
 
HPRA and the National Office said, “The proposed fees reflect the work involved, but are competitive, in order to encourage research in Ireland.” The agencies plan to review the fees after one year as, “There is a level of uncertainty on the scope and volume of work.” Fees could go up or down based on early experience of the work involved in handling submissions under CTR.
 
The Irish authorities are accepting feedback on the proposals until 8 October.
 
Consultation Document
 
Denmark discusses impact of decentralized clinical trials on data integrity
 
The Danish Medicines Agency (DKMA) has updated its DCT guidance with a section about the impact of the model on data integrity.
 
In the new section, DKMA warns that differences in the implementation of DCT elements across trial sites in different countries, for example because of national legislation, may “introduce confounding variables which jeopardises the reliability and validity of the trial.” As such, DKMA wants sponsors to carefully assess the differences to ensure the integrity of data generated in the study.
 
Other changes to the prior guidance include new wording about mitigation plan requirements and a new sub-section covering the integrity of the medical records of trial participants. DKMA has also revised its advice on the implementation of remote source data verification and aligned a section with guidelines from the International Council for Harmonisation.
 
DKMA Guidance
 
MHRA links long-term topical steroid use to withdrawal symptoms
 
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a notice about side effects linked to long-term use of topical steroids after identifying a safety signal in its review of Yellow Card data and the research literature.
 
Following an enquiry from a patient representative, MHRA reviewed the data and found “growing evidence of topical steroid withdrawal reactions if they are used continually for a long time.” MHRA estimates the reactions occur very infrequently but, as they can be “debilitating and long lasting,” it is advising anyone who develops certain symptoms to seek advice from a healthcare professional.
 
MHRA has asked marketing authorization holders to update the product information they provide to healthcare professionals and patients. The agency has created text about special warnings and undesirable effects for manufacturers to add to the Summary of Product Characteristics.
 
MHRA Notice, More
 
Other News:
 
MHRA has found booster shots of COVID-19 vaccines from AstraZeneca, Moderna and Pfizer are safe and effective, including when given at the same time as a flu jab. The UK is now preparing to administer booster vaccines to people aged 50 years and older and high-risk younger people. MHRA Notice 

 

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