Who is this blogger?
Annet Visscher
My name is Annet Visscher and I am a clinical research expert, based in The Netherlands, with over 25 years of experience in all aspects of clinical evidence planning and execution especially in medical devices. I am the co-founder of Applied Clinical Services.
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Recent Posts
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Tweets by AnnetMuetstegeMost used tags
- Adverse Event handling
- Clinical benefit
- clinical evaluation
- Clinical Evidence
- Clinical Evidence Plan
- Clinical Investigation
- Clinical Research
- clinical studies
- Clinical Study Population
- Clinical Trial
- Clinical Trial Investment
- clinicaltrials gov
- Controlled Clinical Trial
- Coronavirus
- Cost Effective
- Country Regulations
- COVID-19
- daily practice
- Data protection
- Data Transparency
- Declaration of Helsinki
- effectiveness
- Efficacy
- Ethics Committee
- EUDAMED
- Europe
- GCP
- GDPR
- Guidelines
- Health Care Market
- Health Economic Model
- Health Economic Outcomes
- Health Technology Assessment
- IIT
- Informed Consent
- informed consent process
- investigator-sponsor
- ISO 14155
- ISO14155
- IVDR
- Market adoption
- MDCG guidances
- MDD
- MDR
- MEDDEV 2.7/1
- MEDDEV 2.12-2
- Medical Device Directive
- Medical Device Regulation
- Medical Devices
- Monitoring
- NICE
- Patient Outcomes
- Patient Safety
- performance evaluation
- PMCF
- post-market clinical follow-up
- Post-market Observational Study
- Postmarket Clinical Follow-Up
- Postmarket Safet Reporting
- Postmarket Safety Reporting
- Postmarket Studies
- Postmarket Surveillance
- Premarket Safety Reporting
- Premarket Study
- Product Claims
- Publication
- Publication Bias
- Publication Strategy
- Registry
- Reimbursement
- remote monitoring
- risk-based monitoring
- Site Monitoring
- Sponsor
- Vigilance
Author Archives: Annet Visscher
IVDR AMENDMENT ADOPTED: HAPPY NEW YEAR!
Set to apply from May 2022 on, the IVDR proposed progressive roll-out has been adopted by the EU as a very welcome Christmas gift. Essential to realize thought is that the amendment does not change the requirements of the IVDR but … Continue reading
Posted in Uncategorized
Tagged clinical studies, COVID-19, diagnostic devices, ISO14155, ISO20916, IVDR, Medical Devices, performance evaluation
2 Comments
COVID-19 SELF TESTS – WHAT ARE THE RESULTS SAYING?
Earlier did a COVID-19 self-test, a test that conform the EU MDCG 2021-2 guidance has instructions for use (IFU) that should be “complete and precise, including aspects such as: the intended user, the target population, window between infection and antibody … Continue reading
Posted in Uncategorized
Tagged CORONA Selftest, COVID-19, daily practice, In-Vitro Diagnostics, IVDR, Sensitivity, Specificity, Usability, User Acceptance Testing
2 Comments
THE NEW ISO 14155: WHAT CHANGED IN THE END?
With the updated references of harmonised standards for medical devices, ISO 14155: 2020 is THE GCP standard for medical device clinical investigations, and since as of May 26th 2021 the MDR fully applies you may want to familiarize yourself and … Continue reading
HOORAY: EU MEDICAL DEVICE CLINICAL TRIAL GUIDANCE ONE MINUTE TO MIDNIGHT!
You probably did read it by now, but just in case, herewith a few items that stood out for me while reading the EU Q&A for clinical investigations under the MDR ((MDCG 2021-6) published jst before the May 26th deadline. … Continue reading
MDR/ IVDR CLINICAL EVALUATION TOOLKIT; PART II
I am very happy that as of April, we have more time until the date of application of the Medical Device Regulation, as well as more clinical guidance to work with. In my previous post I addressed my observations on … Continue reading
MDR/ IVDR CLINICAL EVALUATION TOOLKIT; PART I
After a long period of waiting, several delays, and the MDR deadline without proper guidance hanging above our heads like the Sword of Damocles, as of end of April we have one more year until MDR date of application and … Continue reading
Posted in Uncategorized
Tagged CER, clinical evaluation, Clinical Evidence, IVDR, MDCG guidances, MDR, MDSW, Medical Device Regulation, performance evaluation
2 Comments
COVID-19 CLINICAL EVIDENCE DOWNTIME: HOW TO MAKE USE OF IT!
To date numerous guidances, blogposts, webinars have been published addressing what one must and cannot do in the process of clinical evidence collection due to the COVID-19 pandemic (for overviews see here and here), and with this post I have … Continue reading
CORONAVIRUS AND CLINICAL STUDIES: WHAT TO DO?
By now the Coronvirus outbreak is affecting everyday life worldwide (see latest statistics Johns Hopkins University), and to avoid patient exposure or to reduce the burden on clinical services it also started impacting clinical trials; their execution, monitoring, and publications. … Continue reading
2020 – THE 11th HOUR FOR THE MDR, ISO 14155, & OTHER EU CLINICAL MATTERS
Nothing could have been more illustrative for the medical device clinical trial environment in Europe than the storms Ciara and Dennis in February. With BREXIT as a kick off, the Coronavirus spreading around te globe, the MDR deadline less … Continue reading
Posted in Uncategorized
Tagged clinical evaluation, Clinical Investigation, Clinical Research, ISO 14155, MDR, Medical Devices, Monitoring
2 Comments
EU MDR DEADLINE MAY 2020: CLINICAL EVIDENCE STATE OF AFFAIRS AT YEAR’S END
With less than 5 months to go until application, the development of guidance on the clinical evidence collection process under the EU MDR is progressing scarily slow. The updated overview from December suggests we theoretically will get some more clinical … Continue reading
Medical Devices Clinical 