MDR, IVDR and ISO 14155 clinical activity compliance support

Quality procedure set-up support and compliance review for EU clinical activities: Medical devices and IVDs

Under the new MDR ((EU) 2017/745 Regulation on Medical Devices), many medical device manufacturers will need to generate significantly more clinical evidence for initial CE Mark certification or renewal of their existing CE Marking.

Under the new IVDR ((EU) 2017/746 Regulation on In Vitro Diagnostics), most manufacturers will need to involve Notified Bodies (NB) for the first time to achieve CE Marking of their IVDs (currently, approximately 85% of IVDs on the European market are self-certified by manufacturers). Clinical evidence requirements will also increase significantly for IVDs.

The proper conduct of medical device or IVD clinical activities is regulated by the new Regulations, as well as by EU Member State national laws and regulations and the Good Clinical Practice (GCP) standard ISO 14155 for medical devices or the Good Study Practice Standard ISO 20916 for IVDs. These standards are similar but not identical to US FDA’s GCP regulations. In addition, the European General Data Protection Regulation (GDPR) needs to be respected by medical device and IVD clinical investigators.

Conducting medical device clinical investigations, IVD clinical performance (evaluation) studies and post-market clinical follow-up (PMCF) activities compliant with EU legislation

The responsibility to conduct adequate clinical investigations or clinical performance (evaluation) studies, as well as post-market clinical or post-market performance follow-up activities lies with manufacturers. However, some manufacturers are not (yet) set up to conduct their clinical activities according to MDR and ISO 14155 or IVDR and ISO 20916.

Critical gaps identified by Competent Authorities, especially for manufacturers inexperienced in the conduct of clinical investigations or clinical performance studies, include:

• Missing or inadequate written clinical quality procedures
• Inadequate safety reporting to EU Member State authorities
• Inadequate clinical data monitoring
• Improper or inadequate documentation of clinical activities

Noncompliance with MDR or IVDR, with ISO 14155 or ISO 20916 standards, or to national laws and regulations might lead to the suspension or abrogation of ongoing and planned clinical activities by Competent Authorities or Ethics Committees. In addition, noncompliance will render these clinical data unacceptable to NBs. As a consequence, clinical activities might need to be repeated, and in the worst cases CE certification might not be obtained, or an existing CE Mark might be suspended.

How we help

Our team of clinical experts can help you to ensure your clinical activities are compliant:

• Review of ongoing and previous clinical activities
  Assessing your clinical activities for compliance with the MDR and ISO 14155 or IVDR and ISO 20916 and, if requested, for compliance with EU Member State national laws and regulations. Our clinical research experts can also evaluate whether your activities have been conducted according to your company’s written clinical procedures and clinical investigation plan (CIP) or clinical performance study plan (CPSP).
• Review of clinical documents
  Evaluating clinical documents such as CIPs or CPSPs for compliance with MDR and ISO 14155 or IVDR and ISO 20916. Our clinical research experts will also provide guidance on how to close potential or actual gaps. In addition, Emergo can support your company in generating a CIP or CPSP.
• Support in setting up written clinical quality procedures (SOPs, QSPs)
  Reviewing your existing written procedures and performing a gap analysis to identify potentially missing procedures, followed by guidance on developing additional procedures. This exercise will implement clear responsibilities and criteria for efficient and compliant conduct of clinical activities.

Awareness and proper implementation of clinical activity requirements are essential from the beginning to ensure that regulations and applicable standards are adequately met. Meeting these requirements will facilitate efficient clinical activities, reduce delays and business risks and minimize costs.

Every medical device and IVD company structure is different, and clinical activities can and should be tailored to your needs.

Whether you only require a review of a study plan or an evaluation of your entire clinical quality management system, Emergo can support these clinical activities to guide you through this key element to meet MDR, IVDR and other applicable requirements. Please contact us for more details.