Performance evaluation is a critical part of verification and validation of product performance that is recorded in the supporting technical documentation required to place an in vitro diagnostic device (IVD) on the EU market.
The application of standards in the medical devices sector has undoubtedly been accelerated by their use to support regulation by providing a voluntary means to demonstrate conformity with regulatory requirements.
This paper was first published by BSI in 2018 and has been revised in light of the publication of BS EN ISO 14155:2020. The paper discusses important requirements for pre-market and post-market clinical investigations under the European Medical Device Regulation (2017/745) (MDR), relevant European guidance documents and BS EN ISO 14155:2020, and how this updated standard can help in meeting MDR requirements.
There has been significant evolution in the European regulatory landscape over the past 10–15 years, particularly with respect to requirements for clinical evaluation. These changes have been driven in part by a series of medical device failures, which fuelled a perception, particularly amongst regulators and clinicians, that clinical evidence for medical devices was not receiving sufficient scrutiny in Europe.
Guidance on MDCG 2019-9: Summary of Safety and Clinical Performance
This white paper explains the purpose and contextual background of the Summary of Safety and Clinical Performance (SSCP) and summarizes the key requirements and recommendations from the MDR and MDCG 2019-9 guidance.
This white paper provides an overview of the EU UDI system, its requirements and the status of EUDAMED, along with some practical recommendations for manufacturers to support their UDI system compliance efforts.
Phthalates are plasticizers that impart flexibility to plastic products and can leach into their surroundings. Many phthalates have the potential to cause hormonal disruption. This white paper summarizes the evaluation of phthalates and endocrine-disrupting (ED) substances in medical devices (MDs).
Person responsible for regulatory compliance (PRRC) - MDR/IVDR Article 15
With the MDR and IVDR, European regulators aim to ensure companies have a regulatory expert – a Person Responsible for Regulatory Compliance (PRRC) – at their disposal, to ensure that the company is meeting certain specific EU requirements.