regulatory medical devices
mDR
We obtain all necessary MDR regulatory submission documents to gain approval for medical device clinical trials in an efficient and timely manner. All our staff will be certified to the ISO 14155:2020 standard.
The European Medical Device Regulation (MDR, EU 2017/745) is a regulation established by the European Union (EU) to regulate medical devices and ensure their safety and effectiveness. The regulation applies to all medical devices intended for use in human healthcare within the EU, as well as those manufactured outside the EU but marketed within its member states.
The ISO 14155:2020 (Clinical investigation of medical devices for human subjects – Good Clinical Practice) is the third edition of this standard of reference for the design, conduct, recording, and reporting of medical device clinical studies. It provides guidance to manufacturers and clinical research professionals on how to implement Good Clinical Practice (GCP) for pre and post-market clinical investigations designed to determine the safety and performance of a medical device.
We can do the MDR for you or we can help you do it
We start off strong by highlighting the importance of adhering to HPRA guidelines when completing the clinical trial device application form. This ensures that the trial is conducted ethically and safely for all participants. The following are some tasks that our experts are proficient in.
- The submission package is like a puzzle – it requires careful attention to detail and organization to ensure all the pieces fit together correctly. Emphasize the importance of compiling this package thoroughly and accurately to avoid any delays in the approval process.
- Reviewing documentation may seem like a mundane task, but it’s a crucial step in ensuring the accuracy and completeness of the application. It’s an opportunity to catch any errors or omissions that could potentially impact the outcome of the trial.
- Localizing the Patient Information Leaflet and Informed Consent forms may sound complicated, but it’s actually a way to ensure that all participants fully understand the trial and their rights as a participant. By making the information accessible and easy to understand, it helps to build trust between the participants and the trial team.
- Submitting the application to the Clinical Trial Information System (CTIS) may be the final step in the application process, but it’s also one of the most important. This system helps to streamline the approval process and ensures that all relevant parties have access to the information they need.
- The National Ethics Committee for Medical Devices (NREC) is responsible for evaluating the ethical implications of research involving in vitro medical devices.
- The Clinical Trial indemnity form is an important legal document that protects all parties involved in the trial. Working in conjunction with the hospital authority ensures that everyone is on the same page and that the trial can proceed without any legal complications.
- Finally, completing the Data Protection Impact Assessment (DPIA) is a way to ensure that all participants’ personal data is protected throughout the trial. By collaborating with the Hospital Data Protection Officer, it helps to ensure that the trial is conducted in compliance with data protection laws and regulations.
recent changes in europe
In Europe, there have been significant changes to medical device regulations with the introduction of the new Medical Device Regulation (MDR) in 2017. The MDR replaces the previous Medical Device Directive (MDD) and aims to strengthen the safety and efficacy of medical devices marketed within the European Union (EU). Here are some of the key changes brought about by the MDR:
- Stricter requirements for clinical evaluation: The MDR requires that manufacturers provide clinical evidence to support the safety and performance of their medical devices, with a focus on high-risk devices. This includes new requirements for clinical evaluation and post-market clinical follow-up.
- Unique Device Identification (UDI): The MDR requires that all medical devices carry a unique device identifier (UDI) to enable better traceability and monitoring of devices throughout their lifecycle. This will make it easier to identify and address safety issues with medical devices.
- Enhanced post-market surveillance: The MDR introduces new requirements for post-market surveillance, including the establishment of a European database on medical devices (EUDAMED) to improve transparency and monitoring of medical devices.
- Strengthened Notified Body oversight: Notified Bodies are organizations designated by EU Member States to assess the conformity of medical devices. The MDR introduces new requirements for Notified Bodies, including stricter requirements for personnel, facilities, and procedures.
- Expansion of scope: The MDR expands the scope of medical devices to include certain products that were not previously covered by the MDD, such as certain aesthetic devices, software, and implantable devices for contraception.
These changes represent a significant shift in medical device regulation in Europe and are intended to improve patient safety and enhance the effectiveness of regulatory oversight.
medical device industry ireland
Get ready to be amazed by these 10 mind-blowing stats about the Irish medtech industry!
- Boasting a whopping 450 companies, Ireland’s medtech industry is a force to be reckoned with.
- With a staggering 42,000 people employed in the sector, the Irish medtech industry is a major contributor to the country’s economy.
- Ireland is Europe’s largest per capita employer of medical device professionals, meaning there’s no shortage of talent in this industry.
- As the second-largest exporter of medical device products in Europe, Ireland is making its mark on the global medtech market.
- Ireland is a hub for the world’s top medtech companies, with nine out of the top 10 having operations in the country.
- With annual medtech exports worth €12.6 billion, Ireland is punching well above its weight in the global marketplace.
- Irish-made medical devices are in high demand, with exports reaching over 100 countries worldwide.
- An incredible 80% of stents used across the world are manufactured in Ireland, showcasing the country’s expertise in this area.
- Half of the ventilators used in the world’s acute hospitals are made in Ireland, demonstrating the country’s crucial role in healthcare.
- And last but certainly not least, Ireland is the world’s number one exporter of contact lenses! Who knew?