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 the Clinical Study Informed Consent,
- Medtech EU urging the European authorities to provide timely solutions installing the new regulatory infrastructure to guarantee patient’s continued access to health care as experienced today,
- the EU commission publishing a MDR/ IVDR rolling plan, providing timelines and status overview for the transition period, with attention for common specifications for any of the groups of products listed in Annex XVI of the MDR and the clinical evaluation regarding safety, and designated expert panels tasked with the delivery of opinions on the clinical evaluation of high-risk devices (Q3/ Q4 2019),
- the FDA publishing the final rule on the Acceptance of Data From Clinical Investigations for Medical Devices, a draft guidance for heavy penalties against companies that fail to submit clinical trial results to ClinicalTrials.gov, and a proposed rule on De Novo Classification to improve medical device review,
- the Implant Files, once more (although very one-sided) emphasizing some of the challenges we are facing in the diverse world of medical devices, and that, with the higher clinical evidence demands under MEDDEV 2.7/1 Rev. 4, the MDR, and IVDR, are intended to be addressed in Europe.
Looking ahead to 2019,
- we can expect a revised version of ISO 14155, with (probably) some interesting additions such as more attention for the inter-relationship with device risk management procedures, and the product developmental stages in relation to the different types of pre- and post-market clinical investigations,
- we have entered the second half of the MDR transition phase, basically leaving medical device companies with only one full year to collect the badly needed own qualitative clinical data with products currently on the market.
Please feel free reaching out in case of any questions regarding this post, or when you are looking for support with your medical device clinical evidence strategy.
Happy New Year!