Who is this blogger?
Annet Muetstege - Visscher
My name is Annet Muetstege 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.
Location and time zone
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Recent Posts
Latest Tweets
- FDA updates Covid-19 clinical trial guidance, incl guidance on emergency informed consent process in prospective tr… twitter.com/i/web/status/1… 17 hours ago
- Adding smell tests may enhance accuracy of temperature screening when checking for covid-19. #medicaldevices… twitter.com/i/web/status/1… 5 days ago
- Updated guidance from the IGJ allows for restart of on-site monitoring in close alignment with the concerning healt… twitter.com/i/web/status/1… 1 week ago
- RCT shows potential for dexamethasone in hospitalised COVID-19 patients! #RCT #clinicaltrial #covid19 #efficacy lnkd.in/gNv898B 2 weeks ago
- Do you know what needs to be done for your medical device under the MDR? #medicaldevice #MDR #clinicalevaluation… twitter.com/i/web/status/1… 3 weeks ago
Most 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
- Data protection
- Data Transparency
- Declaration of Helsinki
- effectiveness
- Efficacy
- Ethics Committee
- EUDAMED
- Europe
- GDPR
- Guidelines
- Health Care Market
- Health Economic Model
- Health Economic Outcomes
- Health Technology Assessment
- IIT
- Informed Consent
- informed consent process
- Informed Decisions
- investigator-sponsor
- ISO 14155
- IVDR
- Market Access
- Market adoption
- MDCG guidances
- MDD
- MDR
- MEDDEV 2.7/1
- MEDDEV 2.12-2
- Medical Device Directive
- medical device industry
- Medical Device Regulation
- Medical Devices
- Monitoring
- NICE
- Patient Outcomes
- Patient Safety
- PMCF
- 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
- Randomized Clinical Trial
- Registry
- Reimbursement
- remote monitoring
- risk-based monitoring
- science
- Scientific Credibility
- Site Monitoring
- Sponsor
- Vigilance
Tag Archives: MDR
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
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
6 MONTHS LEFT UNTIL MDR: MORE TIME FOR YOUR CLINICAL EVALUATION?
Update 18-DEC-2019: The EU parliament adopted the second MDR corrigendum, giving manufacturers of Class I medical devices 4 years extra to bring their clinical evaluation in order, putting them in the same position as the other medical devices with a … Continue reading
Posted in Uncategorized
Tagged clinical evaluation, Clinical Evidence, MDD, MDR, MEDDEV 2.7/1, Medical Devices, Postmarket Studies, Premarket Study
1 Comment
THE EU MEDICAL DEVICE CLINICAL ENVIRONMENT: UNCERTAIN TIMES
The medical device regulatory environment in Europe is moving, but not always as timely and as clear as one would wish, certainly not from clinical perspective. The MDR/ IVDR Rolling plan has been updated and mentions clinicals a few times, … Continue reading
MEDICAL DEVICE CLINICAL EVIDENCE HIGHLIGHTS 2018/ 2019: ROARING TIMES IN EUROPE
From a medical device clinical evidence perspective, we are looking back on a turbulent 2018 and forward to an exciting 2019. Highlights of 2018 included, the GDPR becoming effective, with more strict regulations on data handling and the content of … Continue reading
CLINICAL EVIDENCE DILLEMAS: HOW LONG SHOULD PATIENT FOLLOW-UP BE?
The Implant Files touched upon one of the toughest dilemma’s designing a clinical study: How long do patients treated with a medical device need to be followed in a clinical study before one can say the device is safe and … Continue reading
THE MEDICAL DEVICE CLINICAL TRIAL ENVIRONMENT IN EUROPE
One of the topics discussed during the Medical Device Clinical Trial Seminar in Taipei, was the current medical device clinical trial environment in Europe and how that is evolving. A short version of my presentation, you can find on SlideShare … Continue reading
CLINICAL EVALUATIONS & CLINICAL TRIALS IN THE EU – TAIPEI
I am very much looking forward to the Medical Device Clinical Trial Regulations and Practice Seminar in Taipei September 5th, where I will be speaking on the current EU standards regarding Clinical Evaluations and Clinical Trials as well as the … Continue reading
