Updates on Medical Device Regulation (ClinO-MD)
In the course of adapting Swiss legislation to the new EU Medical Device Regulation (MDR), clinical research with medical devices (with the exception of in vitro diagnostics) in Switzerland will be regulated in a separate ordinance. The new “Medical Device Regulation” (ClinO-MD) will come into force on May 26, 2021, at the same time as the MDR.
According to the update posted on the Swiss National Clinical Trials Portal (SNCTP) on April 20, 2021, in addition to the existing obligation to prospectively register the clinical trial, the results of the trial must now also be published in a trial registry. This will also apply to clinical trials which will be still underway when the ClinO-MD enters into force on May 26, 2021. As Eudamed cannot currently be used for this purpose, the registration and publication of results must therefore be carried out in an international trial registry, such as ClinicalTrials.gov.
Other than the disclosure requirements other changes regarding clinical trials with medical devices under the ClinO-MD are:
- Updated categorization of the medical devices
- Differentiating clinical trials as conformity-related and non-conformity-related
- Adaptation of application documents to be submitted
- Reply deadline for sponsors
For more details, please refer to Clinical trials with medical devices: Expected changes in the legal requirements.
During the COVID-19 pandemic, EMA is implementing exceptional measures to maximise the transparency of its regulatory activities on treatments and vaccines for COVID-19 that are approved or are under evaluation.
EMA is achieving this by shortening its standard publishing timeframes and publishing information it does not normally publish for other medicines.
Under this practice, the clinical trial data for COVID-19 medicines will be published on clinical data website after marketing authorisation. As a standard practice, such publication is suspended until further notice for other medicines.
The Pink Sheet article dated July 17th reported on a July 1st session at the DIA Europe 2020 Conference on “Clinical Trial Regulation: State of Play – Are We Ready?”. Judith Creba speaking on behalf of the European Federation of Pharmaceutical Industries and Associations (EFPIA) addressed industry’s preparedness for the new legislation noting “We are as ready as possible, but there are still some unclear aspects, mostly related to CTIS which is understandable as it is still under development.” Creba, who is leading the CTR’s implementation within Novartis, said the key thing needed to help get the industry fully ready was to provide companies with access to a ‘test’ CTIS database to help them understand how the system works in practice. Both Creda and Rüdiger Pankow of Parexel, raised concerns that many in industry have previously echoed concerning lack of any inside knowledge of the CTIS under development which makes it challenging to have updated internal standard operating procedures to reflect the new procedures and allow for training prior to implementation of the CTR.
Agnès Mathieu-Mendes, deputy head of the unit dealing with the quality, safety and innovation of medicinal products in the Commission’s Directorate General on Health and Food Safety, also stated that a number of new guidance documents and templates are being prepared to help the industry prepare for the legislation. Work is ongoing to develop new Q&A documents on CTR “hot topics,” such as classification of substantial and non-substantial amendments to a clinical trial, and allowing post-trial treatment access to participating subjects.
The CTIS audit is slated to begin in December 2020 with a proposed ‘Go-Live’ date of CTIS (as well as CTR implementation) in December 2021.
As per the State of play of Joint implementation Plan on actions considered necessary to ensure the sound functioning of the new framework for medical devices under the MDR, the priority action for transparency was to issue a fact sheet on information to become publicly accessible.
This Factsheet on MDR requirements for Transparency and Public Information has been published on July 15, 2020. Most of the requirements on Transparency and public access to information are linked to the Eudamed, which is planned to become fully functional by May 2022.
The transparency requirements under the MDR can be divided into different categories:
- Information on medical devices made accessible to the public in Eudamed
- Information which is pro-actively made publicly available outside Eudamed by the Commission, the national competent authorities, the industry or the notified bodies
Thus, the fact sheet has presented the MDR transparency requirements separately depending on whether they will be available in or outside the Eudamed database.
The following update was posted on EudraCT What’s New section, on July 10, 2020:
The Joint Technical Notice to Sponsors by the European Commission, EMA and HMA was published yesterday on the European Commission health website.
It emphasizes that if a qualified person (QP) (for certifying the batch-release, so that the drug product can be imported) and the sponsor of a clinical trial or a legal representative (in case the sponsor is established in a third-country) is established in the United Kingdom, such a person and sponsor or the legal representative must be established in the EU if the clinical trial is authorized in at least one EU member state.
Sponsors of all ongoing trials need to establish a QP in the EU. Failure to do so could in the worst case result in discontinuation of trial treatment and thus jeopardise trial participants’ safety.
At the end of the transition period, the sponsor or its legal representative has to be established in the EU for all ongoing trials. Failure to meet this requirement will be a breach of Directive 2001/20/EC and could trigger a request for corrective actions by Member State competent authorities.
The European Medicines Agency (EMA) has published Issue 1 of their newsletter CTIS Highlights on July 03, 2020.
The newsletter will include news, views and interviews for the Clinical Trials Information System. Also, it will be published twice a year by the EMA.
The current issue provides an overview of the CTIS including the technical environment of CTIS, involvement of stakeholders, training strategy, etc. Additionally, the newsletter also reiterates that as a working assumption, it is proposed to fix the Go-Live date of CTIS to December 2021, which means the Clinical Trial Regulation would also enter in application at that time.
The EudraCT & EU-CTR Question and Answer table (Frequently Asked Questions and Answers V1.8) has been updated on July 06, 2020.
Questions related to registering a new trial, primary user, reporting statistical analysis data for a single arm study design and availability of the results in the public domain are updated. Also, two new questions are added under Paediatric Clinical Trial Information.
The European Commission and European Medicines Agency (EMA) on April 28th updated their Guidance on the Management of Clinical Trials During the COVID-19 (Coronavirus) Pandemic adding advice on distribution, data verification and communicating with authorities. The updated EMA guidance follows an April 16th similar update from the FDA, which added seven new questions and answers to its document. The update marks the third version of the guidance from the Commission, EMA and the Heads of Medicines Agencies and provides new recommendations on the distribution of investigational medicinal products (IMPs) and data verification under social distancing measures and resource limitations.
The guidance also clarifies how clinical trial sponsors should communicate urgent issues to regulatory authorities. “The aim is to mitigate the disruption of clinical research in Europe and therefore the negative effects of the pandemic, without compromising on quality and safety,” the Commission said in April 28th press release, noting that the guidance will be revoked once the crisis in Europe has passed.
On April 08, 2020, Ropes & Gray published a document comparing the guidance documents related to COVID-19, its impact on and additional requirements for conducting the clinical trials. The guidance documents involved are issued by the European Medicines Agency (“EMA”), the French National Agency for Medicines and Health Products Safety (“ANSM”), the German Federal Ministry of Health (“BfArM”), the Italian Medicines Agency (“AIFA”), the Spanish Agency for Medicines and Health Products (“AEMPS”), Switzerland’s Swissmedic and swissethics, the Australian Department of Health, the Brazilian Health Regulatory Agency (“ANVISA”), Health Canada, and Singapore Health Sciences Authority (“HSA”).
Earlier, on April 02, 2020, a comparative chart was published summarizing the guidance documents issued by FDA, EMA, MHRA and PMDA.
The comparisons include initiating a new clinical trial, continuing a clinical trial, any changes (amendments) to a clinical trial, informed consent changes, study visits, COVID-19 screening procedures, monitoring
activities, investigational product distribution and study reporting.
Survey on the Swiss National Clinical Trials Portal (SNCTP)
A survey is being conducted on the Swiss National Clinical Trials Portal (SNCTP) to find out more about its intended purpose and user friendliness.
Please click here for more details.