MedReg - The blockchain for global regulatory compliance of medical devices and IVD
Select Medical Device and In-Vitro Diagnostics companies are invited to participate in the MedReg blockchain project in an effort to significantly reduce global regulatory and administrative expenses.
The MedReg Blockchain will allow participants to use a platform that provides them with immutable proof for compliance and cost sharing purposes. Each participant will be able to launch smart contracts on the platform, yet the platform itself is not controlled by any one company or IT vendor.
Participation in the pilot project consists of the following phases:
About MedReg International
The International Organisation for Medical Device Regulation Compliance, Patient Safety and Blockchain Security (MedReg International or MedReg) works with research institutes, universities and hospitals for clinical investigations of medical devices to create the highest possible standards for patient safety around the world while automating all processes on the blockchain in order to minimise the administrative and regulatory burden for medical device manufacturers and to minimise cost for medical facilities - and ultimately patients.
Based on data protection laws and regulations and with the consent of hospitals and patients, authorised personnel creates a video and electronic documentation for Real World Evidence ("RWE").
MedDev can also process RWE for the supply chain, storage, manufacturing and delivery as well as required training, maintenance and supervision of medical devices and records all information on the blockchain.
Patient data is stored confidentially and each single-use access requires a patient's private electronic key or the key of an authorised Medical Doctor to be decrypted and accessed. With a patient's permission, Smart Contracts that analyse a patient's data can also automatically access a patient's anonymised information and results are accessible by the patient's authorised Medical Doctor or by additional authorised Smart Contracts for further analysis.
Public information about a manufacturer's medical device will be available worldwide through the MedReg public blockchain which is accessible by participating government information systems.
Confidential information that is available to notified bodies, government bodies and authorised MedReg personnel is only accessible with multiple private keys to assure the confidentiality of a manufacturer's data.
Guidance developed for medical devices at an international level, in particular in the context of the Global Harmonization Task Force (GHTF) and its follow-up initiative, the International Medical Devices Regulators Forum (IMDRF), is taken into account to promote the global convergence of MedDev Smart Contracts in an effort to contribute to the highest possible level of safety protection worldwide, and to reduce regulatory and administrative expenses for device manufacturers, in particular in the provisions on Unique Device Identification, general safety and performance requirements, technical documentation, classification rules, conformity assessment procedures, clinical investigations, biocompatibility validations, process validations and other relevant strategies.
About MedReg Smart Contracts and Smart Medical Devices
MedReg Smart Contracts are semi-autonomous, decentralised programs that can be terminated with proper authorisation of private key holders. This is intended to maximise the security and privacy of patients and their medical records related to the use of medical devices and other connected treatments.
Like Smart Contracts, MedReg Smart Contracts have the same ability of accessing and analysing information on the blockchain to automate many processes that would typically require review and analysis by medical staff, therefore resulting in higher patient safety due to a MedReg Smart Contract's ability to process, compare and analyse enormous amounts of patient data on a global scale within the shortest possible time frame, and providing results to Medical Doctors and anonymised data to device manufacturers to improve treatment and the development of the next generation of Smart Medical Devices.
The MedReg blockchain attempts to save medical device manufacturers a large portion of regulatory expenses by sharing administrative costs with many participants.