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Methods Inf Med 2021; 60(03/04): 116-122
DOI: 10.1055/s-0041-1735165
Short Paper

A Modular Approach to Combine Postmarket Clinical Follow-Up Studies and Postmarket Surveillance Studies

Andreas Ziegler 
1   Cardio-CARE, Medizincampus Davos, Davos, Switzerland
2   School of Mathematics, Statistics and Computer Science, University of KwaZulu Natal, Pietermaritzburg, South Africa
3   Department of Cardiology, University Heart & Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
,
Kristin Forßmann
4   Syntellix AG, Hanover, Germany
,
Sabine Konopka
5   Phenox GmbH, Bochum, Germany
,
Katja Krockenberger 
6   Amedon GmbH, Lübeck, Germany
› Author Affiliations Funding None.
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Abstract

Background The European Medical Device Regulation 2017/745 (MDR) has its date of application in May 2021. This new legislation has refined and expanded the need of manufacturers to have a postmarket surveillance (PMS) system. According to this legislation, a postmarket clinical follow-up (PMCF) plan is also required. Manufacturers of high-risk medical devices are obliged to conduct both PMCF and PMS studies. There is thus the need to generate evidence from clinical data.

Objectives The conduct of several studies for PMS and PMCF can be cumbersome. We therefore aim to present a modular approach to combine PMS and PMCF studies into a single study.

Materials and Methods We extracted the topics listed in the MDR, especially Annex XV, Section 3, the Good Clinical Practice for medical devices (EN 14155:2020, Annex A). In addition, we added topics according to the SPIRIT and the SPIRIT-PRO statement and created a draft clinical investigation plan (CIP).

Results The CIP template is provided as part of the manuscript. The modular concept has passed the required regulatory and legal requirements for one specific study.

Conclusion A modular approach for combining PMCF and PMS studies in a single CIP has been developed and implemented, and it is ready for use. The provided CIP template should enable other researchers and groups to adopt this concept according to their needs.

Keywords

clinical investigation plan - good clinical practice - medical device regulation - postmarket clinical follow-up - postmarket surveillance

Note

All relevant data are within the manuscript and its Supporting Information files.


Authors' Contributions

A.Z. supported in the methodology, supervision, writing the original draft, and reviewing and editing of manuscript. K.F., S.K., and K.K. helped in the methodology, and reviewing and editing of manuscript.


Supplementary Material



Publication History

Received: 09 April 2021

Accepted: 05 July 2021

Article published online:
27 August 2021

© 2021. Thieme. All rights reserved.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 

  • References

  • 1 Maisel WH. Semper fidelis–consumer protection for patients with implanted medical devices. N Engl J Med 2008; 358 (10) 985-987
    CrossrefPubMedGoogle Scholar
  • 2 Samore MH, Evans RS, Lassen A. et al. Surveillance of medical device-related hazards and adverse events in hospitalized patients. JAMA 2004; 291 (03) 325-334
    CrossrefPubMedGoogle Scholar
  • 3 Kramer DB, Xu S, Kesselheim AS. Regulation of medical devices in the United States and European Union. N Engl J Med 2012; 366 (09) 848-855
    CrossrefPubMedGoogle Scholar
  • 4 Keogh B. Poly Implant Prothèse (PIP) breast implants: final report of the expert group. 2012 . Accessed March 11, 2021 at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/214975/dh_134657.pdf
    PubMedGoogle Scholar
  • 5 The Lancet Oncology. Catching up on medical device safety. Lancet Oncol 2019; 20 (01) 1
    CrossrefPubMedGoogle Scholar
  • 6 Hauser RG. Here we go again–another failure of postmarketing device surveillance. N Engl J Med 2012; 366 (10) 873-875
    CrossrefPubMedGoogle Scholar
  • 7 Bundestag. Gesetz zur Errichtung des Implantateregisters Deutschland und zu weiteren Änderungen des Fünften Buches Sozialgesetzbuch (Implantateregister-Errichtungsgesetz – EIRD). Bundesgesetzbl. 2019;Teil 1, Nr. 48, 17.12.. 2019: 2492-2509 Accessed 2021 at: https://dserver.bundestag.de/brd/2019/0506-19.pdf
    PubMedGoogle Scholar
  • 8 European Parliament, Council of the European Union. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. O J EU . 2017;L 117(5.5.2017):1–175; revision as of 124.104.2020. Accessed 2021 at: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745
    PubMedGoogle Scholar
  • 9 Arbeitskreis Medizinischer Ethik-Kommissionen in der Bundesrepublik Deutschland e. V. Zusätzliche invasive oder andere belastenden Untersuchungen gemäß § 23 MPG. 2016 . Accessed May 27, 2021 at: https://www.akek.de/wp-content/uploads/Empfehlung23b_MPG1.pdf
    PubMedGoogle Scholar
  • 10 Ross JS, Blount KL, Ritchie JD, Hodshon B, Krumholz HM. Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey. Med Devices (Auckl) 2015; 8: 241-249
    PubMedGoogle Scholar
  • 11 ISO, ISO 14155:2020(E). Clinical investigation of medical devices for human subjects—Good clinical practice. ISO; 2020
    Google Scholar
  • 12 Chan AW, Tetzlaff JM, Altman DG. et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013; 158 (03) 200-207
    CrossrefPubMedGoogle Scholar
  • 13 Calvert M, Kyte D, Mercieca-Bebber R. et al; the SPIRIT-PRO Group. Guidelines for inclusion of patient-reported outcomes in clinical trial protocols: the SPIRIT-PRO extension. JAMA 2018; 319 (05) 483-494
    CrossrefPubMedGoogle Scholar
  • 14 Chen BE, Urton A, Sadura A, Parulekar WR. Principles of Protocol Development. In: Piantadosi S, Meinert CL. eds. Principles and Practice of Clinical Trials. Springer International Publishing; 2019: 1-18
    Google Scholar
  • 15 Cameli M, Novo G, Tusa M. et al. How to write a research protocol: tips and tricks. J Cardiovasc Echogr 2018; 28 (03) 151-153
    CrossrefPubMedGoogle Scholar
  • 16 Rout CC, Aldous C. How to write a research protocol. S Afr J Anaesthesiol Analg 2016; 22 (04) 101-107
    CrossrefPubMedGoogle Scholar
  • 17 Rosenthal R, Schäfer J, Briel M, Bucher HC, Oertli D, Dell-Kuster S. How to write a surgical clinical research protocol: literature review and practical guide. Am J Surg 2014; 207 (02) 299-312
    CrossrefPubMedGoogle Scholar
  • 18 Taylor RB. How to write a research protocol. Medical Writing: A Guide for Clinicians, Educators, and Researchers. Springer International Publishing; 2018: 239-260
    Google Scholar
  • 19 Feldmann U. Qualification of the responsible trial statistician. Biom J 2002; 44 (01) 117-126
    CrossrefPubMedGoogle Scholar
  • 20 Schmidt C, Öner A, Mann M. et al. A novel integrated care concept (NICC) versus standard care in the treatment of chronic cardiovascular diseases: protocol for the randomized controlled trial CardioCare MV. Trials 2018; 19 (01) 120
    CrossrefPubMedGoogle Scholar
  • 21 Könneker S, Krockenberger K, Pieh C. et al. Comparison of SCAphoid fracture osteosynthesis by MAGnesium-based headless Herbert screws with titanium Herbert screws: protocol for the randomized controlled SCAMAG clinical trial. BMC Musculoskelet Disord 2019; 20 (01) 357
    CrossrefPubMedGoogle Scholar
  • 22 Ziegler A, Mann M, Brandewiede B. et al. Statistical analysis plan for the randomized controlled trial CardioCare MV investigating a novel integrated care concept (NICC) for patients suffering from chronic cardiovascular disease. Trials 2020; 21 (01) 131
    CrossrefPubMedGoogle Scholar
  • 23 Göpel W, Kribs A, Ziegler A. et al; German Neonatal Network. Avoidance of mechanical ventilation by surfactant treatment of spontaneously breathing preterm infants (AMV): an open-label, randomised, controlled trial. Lancet 2011; 378 (9803): 1627-1634
    CrossrefPubMedGoogle Scholar
  • 24 Vonthein R, Ohmann C, Ziegler A. Klinische Studien mit Medizinprodukten. In: Mildner R. ed. Regulatorische Anforderungen an Medizinprodukte: Einführung und Handlungshilfen - von klinischer Bewertung bis HTA. Medizinisch Wissenschaftliche Verlagsgesellschaft. 2012: 58-82 . Schriftenreihe der Telematikplattform für Medizinische Forschungsnetze (TMF)
    Google Scholar
  • 25 Ziegler A, Heimerl A, Krockenberger K, Hemmelmann C. Nutzen von Medizinprodukten: Lösungsansätze bei der Planung und Durchführung von Studien. Z Evid Fortbild Qual Gesundhwes 2012; 106 (05) 322-331 , discussion 332
    CrossrefPubMedGoogle Scholar
  • 26 Ziegler A, König IR. Leitlinien für Forschungsberichte: deutschsprachige Übersetzungen von CONSORT 2010, PRISMA und STARD. Dtsch Med Wochenschr 2011; 136 (08) 357-358
    Article in Thieme ConnectPubMedGoogle Scholar
  • 27 Bossuyt PM, Reitsma JB, Bruns DE. et al; STARD Group. STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. BMJ 2015; 351: h5527
    CrossrefPubMedGoogle Scholar
  • 28 Krockenberger K, Knaup P, Bez K, Gleiter CH. The necessity of an electronic SOP retrieval system. Stud Health Technol Inform 2005; 116: 1000-1003
    PubMedGoogle Scholar
  • 29 Ertelt D, Hemmelmann C, Dettmers C, Ziegler A, Binkofski F. Observation and execution of upper-limb movements as a tool for rehabilitation of motor deficits in paretic stroke patients: protocol of a randomized clinical trial. BMC Neurol 2012; 12 (01) 42
    CrossrefPubMedGoogle Scholar
  • 30 No authors listed. Observational post-market surveillance registry including subjects treated with biodegradable magnesium-based implants specific for the intended use. Accessed March 24, 2021 at: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00022381
    PubMedGoogle Scholar