EU Parliament Adopts New Diagnostics and Medical Device Regulations
The European Parliament has endorsed the new InVitro Diagnostic Medical Devices (IVDR) and the new Regulation on Medical Devices (MDR) at a sitting today (April 5th, 2017). The long-awaited final vote is the last step in an almost 8-year process to update the legislation that was first written in the 1990’s.
There has been a widespread welcome for the new regulations from across the industry. The regulations will strengthen patient safety and will provide more clarity on access to new and innovative technologies. Speaking following the vote in the European Parliament, CEO of MedTech Europe, Serge Bernasconi said “Medical technologies save lives, improve health and contribute to sustainable healthcare. The Commission, the Council, and the European Parliament have recognised the specific and differing nature of the two types of technologies when building these two new regulations and we welcome this vote that allows the industry to begin the work needed to transition the two sectors to the new rules within the set timeframes”.
The new legislation provides for:
- random inspections of producers’ facilities after devices have been placed on the market,
- stricter controls on notified bodies, which will have to employ medically skilled people, an additional safety checking procedure for high-risk devices, such as implants or HIV tests. Not only a notified body but also a special committee of experts will check that all requirements are met,
- an “implant card” for patients, enabling patients and doctors to track which product has been implanted,
- clinical evidence of medical device safety to be provided by manufacturers (as for medicines), especially in the case of higher risk classes.
A separate law will also ensure that the new rules also apply to in-vitro diagnostic medical devices, i.e. those that are not in direct contact with the patient but provide health information, such as HIV, DNA, or blood testing devices.
We can help you to deal with the complexities of the new IVDR and MDR regulations. Contact us today on 00353 52 61 76 706 or complete your details below and we will get back to you. You can read more about the MDR & IVDR services provided by the Acorn Regulatory devices team here.
Further Reading on MDR & IVDR
Since the above article was first written (in April 2017), we have written extensively about the new medical device regulations. You can read some of the most read MDR articles below.
The 5 Responsibilities of the Person Responsible for Regulatory Compliance (PRRC) under MDR
As part of our series of articles looking at some of the changes on the way for medical device regulation under MDR, we are looking at the role of the Person Responsible for Regulatory Compliance (PRRC).
The role of QP is a familiar one for those working in the Pharma sector, but this is the first time in European medical devices legislation that a person is required to be appointed by a manufacturer to take specific responsibility for regulatory compliance of devices. Read more here.
Get The Acorn Regulatory Medical Device Regulations Whitepaper
The new medical device regulations (MDR) will come into force in May 2020. In advance of the deadline, companies across the world are working to ensure that their devices will comply with the new regulations. For many companies, there is still much work to do. Also, companies are still actively seeking further information about the regulations and how they will be applied. Read the first whitepaper here
2nd Acorn Regulatory MDR Whitepaper
Our second Acorn Regulatory MDR whitepaper looks at the issues of unique device identifiers, the role of Eudamed under MDR and post-market surveillance. Read the second MDR whitepaper here.
The Medical Device Regulations – MDR – What You Need To Know
The introduction of the new medical device regulations in May 2020 will bring significant changes to the way that we work with medical devices. Our medical device team has been working with many companies to support them for the changeover from the MDD to MDR. During the course of our interactions with these clients, there are many topics that are being raised time and again. Read more here.