ISO 14155 2011.pdf

ISO 14155 2011.pdf

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The first edition of ISO 14155-1 was published on 15 February 2003. The second revision of the standard was released in February 2011, the third revision and therefore current version of the standard was released in July 2020, ISO 14155:2020.

The standard ISO 14155:2011 is an assessable standard and hence is certifiable. The standard regards good clinical practices and protocols for the clinical investigations and plans of medical devices. The assessment is carried out following defined protocols in this international standard.

ISO 14155:2011 addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.

The principles set forth in ISO 14155:2011 also apply to all other clinical investigations and should be followed as far as possible, depending on the nature of the clinical investigation and the requirements of national regulations.

ISO 14155:2011 specifies general requirements intended to protect the rights, safety and well-being of human subjects, ensure the scientific conduct of the clinical investigation and the credibility of the results, define the responsibilities of the sponsor and principal investigator, and assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.

In contrast with previous regulations, all Post-Market Clinical Follow-up (PMCF) clinical investigations will have to be conducted in compliance with the ISO 14155 standard. Although some PMCF investigations may be exempted from a number of requirements, the basic necessities remain applicable, such as implementing written quality procedures, monitoring and document management. Another necessity is using a compliant method of data collection and processing such as Castor EDC.

The introduction of the MDR triggers significant changes to the regulatory landscape for medical devices and adds new requirements for clinical investigations. Namely, the MDR specifies that clinical investigations should be in line with ISO 14155:2011 on good clinical practice (MDR (64): p. 9) and that sponsors should provide evidence that clinical investigations are conducted in line with good clinical practice (MDR Annex XV Chapter III Point 6: p. 172). In addition, under the MDR both pre- and post-market clinical studies count as a clinical investigation, which extends the requirement to comply with good clinical practice to post-market trials, both interventional and observational types.

According to ISO 14155:2011 (6.8), all data shall be generated and maintained in a way that enables control and traceability of the data. The new ISO 14155 (7.8) adds reliability and integrity to these requirements as well as validation of electronic clinical data systems used to evaluate authenticity, accuracy, reliability and consistent intended performance of the data system. These requirements impact both the data generated and held by manufacturers and those generated in the setting of an IIS. As a result, both sponsor-generated and IIS-generated data must be collected and processed using compliant data capture systems and CRFs. In this context, using an established EDC vendor that offers a fully validated and compliant system as well as the opportunity to validate study-specific CRFs is of crucial relevance.

According to ISO 14155, monitoring of clinical data is the act of overseeing the progress of a clinical investigation and to ensure that it is conducted, recorded and reported in accordance with the CIP, written procedures, ISO 14155, and other applicable regulatory requirements. Sponsors are responsible for identifying and using qualified professionals for this function and should evaluate the nature of monitoring that is appropriate for the specific clinical investigation. In addition, monitoring plans (MP) that outline the activities done per visit type (site initiation visit, interim monitoring visit, close out visit) as well as the type of reporting must be compiled. In exceptional circumstances such as for certain registries, centralized monitoring may be sufficient. For most post-market studies monitoring of primary endpoints may be sufficient, however this should be adequately justified in the MP (ISO/DIS 14155:2018 section 6.7; EU MDR Article 71 point 2).

Dear Nancy and team, we heard recently that under the new 14155, the point of enrollment will be the patient's signature of the informed consent form. Is this correct? Do you know if this was one of the key-conditions for the FDA delegates to accept the standard?Thank you very much

Thanks Nancy. Understood. Along the same lines: in pharma trials, it is typical to collect only SAEs (i.e. no more AEs) 30 days after the last dose of the investigational drug. In the case of an implantable device, however, when is it reasonable to stop collecting AE data and only collect ADEs, SAEs, incidents and deficiencies? 6.4.1 of ISO 14155:2011 seems to suggest that we must always collect them (that means collecting, say, colds and flu data even 12 months after an implant) whereas A.14.d appears to suggest that it is up to the sponsor in the CIP to define such timelines. If the CIP defined all AEs until 30 days after implant and then only SAEs, ADEs and incidents/deficiencies for the rest of the study, would that work?

we are engaged in developing combinatin product-Drug delivery system.The first step is creating micro channels in the skin using a elctro programable device.After this initial step we apply drug patch on the skin.All clinical studies are condcted under ICH 6. What we are missing if we do not follow 14155? Do we need to follow /do some thing differently?We collect sae only about 1-2 weeks folllowing stop of the study unless their is an event that needs follow up.

It is my understanding that With the exception of India, most of the member states of AHWP have stated they will implement ISO 14155:2011 for the conduct of medical device clinical investigations in their country. This includes countries such as China, Singapore, Indonesia and many more. It does not include Japan.

Hi Lisa,My European friends say "any day now", but it has not been adopted as of 30March2012. You can check at this website: -standards/harmonised-standards/medical-devices/index_en.htm Search for "14155" and see if the 2011 version is listed. Nancy

The document represents a review of ISO 14155 version 2011 and major changes applied thereto with the publication of the version Iso 14155:2020. The summary of changes are provided here to the best of our knowledge, although produced by the convener of the TC 194 WG4, Danielle Giroud, WMDO, nor Danielle Giroud can be held liable for any of its contents when applied by readers in their procedures or daily activities.

ISO 14155:2020 guides clinical research professionals and medical device manufacturers regarding the implementation of Good Clinical Practice (GCP), which they can apply in pre and post-market clinical investigations. These market investigations are designed to determine the safety and performance of a medical device.

ISO 14155 has been ready for implementation since its publication, i.e., July 2020. Even though the 3rd version of the standard contains many new updates, clarifications, and guidance, it should not significantly change the sponsors and clinical research professionals conducting trials according to ISO 14155:2011. It will also be necessary for both of them to ensure compliance with the 3rd version ISO 14155 while designing MDR clinical strategies and clinical investigations.

ISO 14155 is available for purchase from any ISO member. Purchasing its PDF and e-Pub layout will facilitate clinical research teams with different valuable tools which they can use to show compliance to the standard.

Considered pioneers in the medical device manufacturing industry, TSQ and E are providing ISO 14155:2020 compliant systems to medical device manufacturers worldwide. Our consultancy will help you in the proper adoption of ISO 14155 compliant systems, and you will be able to attain international recognition for your clinical investigations. Contact us today through our website tsquality.ch.

Designing and conducting a clinical trial should be done with good clinical practice (GCP) and quality in mind to ensure the reliability of trial results as well as to follow requirements of regulatory authorities. Organizations usually understand the necessity of following ICH E6(R2) to ensure GCP; however, there is frequently a gap in training internal teams, contractors, CROs, and sites on ISO 14155:2020 GCP for medical devices. Following the standard is a key part of building globally recognized GCP into the full life cycle of the medical device clinical trial and can complement the current GCP training.

The new version of the ISO 14155:2020 standard better aligns with the European Medical Device Regulation (EU MDR 2017/745), the ICH E6(R2) guideline on Good Clinical Practice, and FDA guidance documents, with a focus on medical devices. These updates allow the standard to remain relevant and maintain acceptance by the global medical device industry. The main focus of the updates is on increasing safety and data reliability. For example, a new section adds GCP principles in alignment with ICH E6(R2) and the Declaration of Helsinki.

Because medical device trials can be very costly in the U.S., they are frequently conducted in other countries. Data collected in foreign nations that follow ISO 14155:2020 are recognized by the FDA as clarified in the guidance Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions.6 A final rule that updated 21 CFR Part 814 in February 2018 allows data collected in the EU to be used in the submission of an investigational device exemption (IDE) application, a premarket notification (510(k)) submission, a request for De Novo classification, a premarket approval (PMA) application, a humanitarian device exemption (HDE) application, or a product development protocol (PDP) application. 2b1af7f3a8