Myloy Health supports companies in the supply of high-quality medical devices in order to enable healthcare professionals to provide the best possible healthcare service to patients while in their care. It is ensured that all medical devices are certified for their intended use.
Companies are guided and supported in meeting the requirements and implementing the new EU Medical Device Regulation 2017/745 (MDR) which came into effect on 26th May 2021 after a 1-year delay of the original implementation date.
Being a regulation, the EU MDR 2017/745 is immediately applicable and enforceable by law in all EU Member States.
The support provided depends on the type of economic operator the company is:
- Authorised Representative
- A person referred to in Article 22(1) and 22(3) of the EU MDR 2017/745
Our support includes:
- Helping Economic Operator adhere to responsibilities
- Establishment and maintenance of a Quality Management System
- Implementation of necessary Quality Assurance and Quality Control procedures
- Application for designation as a Notified Body
- Classification of medical devices
- Achievement of ISO standards (such as ISO 9001:2015)
- Warehouse compliance to requirements of Good Distribution Practice
- Temperature control and monitoring during storage and transport
- Guidance regarding Declaration of Conformity DoC and CE marking
- EUDAMED registration
- Support for challenges encountered in procurement and practical use
- Unique Device Identifier (UDI) implementation through barcode system
- Fulfilling responsibilities of identification and checking of UDI
- Supporting Vigilance procedures necessary to ensure safety of the medical device
- Implementation of Field Safety Corrective Actions (FSCA) in a timely manner
- Incident Reports and Recalls
- Checking the printed labelling information on pack and Instructions For Use (IFU)
- Support in the preparation for implementation of the In vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR)
National Competent Authority
In Malta the National Competent Authority responsible for regulating medical devices is the Malta Medicines Authority (MMA). Within the Malta Medicines Authority, the Medical Device Unit has the regulatory role to monitor all medical devices placed on the local market and to ensure they are safe for the patients and they function as per intended use.
Economic operators need to be registered with the Malta Medicines Authority. Site audits and inspections for local economic operators will be carried out. Through a national centralised management system, a listing of medical devices placed on the local market will be available. This system will also be utilised for incident reporting.
Notified bodies are also registered and monitored by the Malta Medicines Authority.