By now, all MedTech industry members are aware of the EU MDR, which is keeping everyone on their toes. The new European Union Medical Device Regulation (EU MDR) was published in the Official Journal of the European Union on May 5th 2017 and “entered into force” 20 days later on 26 May 2017. Following the disruption caused by COVID-19 pandemic MEDICAL DEVICE REGULATION (EU) 2017/ 745 [EU MDR] came into application on 26th May 2021.
A lot has changed since 26th May, 2021 as the industry witnessed
- Increase in number of Notified Bodies.
- Extension of Transitional Deadlines for certain medical devices.
- Post Brexit relation of EU MDR with UK MDR
The transition from EU Medical Device Directives (MDD) to the new EU MDR regime saw an increased emphasis on patient safety, traceability and post-market surveillance requirements. The top 3 changes which came into effect from 26th May 2021 under the new MDR included:
- Need for PRRC
Person Responsible for Regulatory Compliance (PRRC) is an entirely new role which the MDR and IVDR have introduced.
The PRRC is responsible for ensuring the manufacturer’s compliance with the regulations. This person should be the organisation’s employee, but services can also be outsourced but only if a micro or small enterprise. The PRRC should be permanently and continuously at the company’s disposal.
With the introduction of PRRC, our experts would like to highlight the fact that MDR lays more emphasis on the roles and responsibilities of a European Union Authorised Representative [EUAR]. As a non-EU manufacturer, you must appoint a EUAR who can represent your company to the European Commission. A EUAR is not just a post box service but rather an equal partner responsible for compliance, sharing the same legal liability as a manufacturer.
- Reclassification of SaMD
Rule 11 of the Medical Device Regulation (MDR) has the potential to push Software as a Medical Device (SaMD) from the lowest risk classification (Class I) into the higher risk classes (Class IIa/b or III).
This means that manufacturers of SaMD will move from a self-notification process to having to engage a Notified Body resulting in more regulatory compliance activities, additional resources required to ensure compliance and a significant increase in financial costs.
- Increased Post Market Responsibilities
The MDR places much greater emphasis on monitoring the performance of CE-marked medical devices, i.e. post-market surveillance (PMS). PMS is required regardless of the medical device classification, but requirements will vary because it will be proportionate to the risk classification.
When we looked at MDR for the first time, we could see it as a time demanding monster! A monster attacking innovations, overburdening administration and forcing companies to invest more resources into regulatory affairs. When MedTech Europe welcomed the first wave of the new EU medical device regulation they warned, “..there’s work that’s yet to be done.”
However, when we inspect and investigate further, we see MDR as an opportunity!
There is a massive potential for innovation, provided all processes are thoroughly prepared and followed by the organisations. Apart from the scope of innovation, MDR is a booster for expanding the medical device manufacturing industry as it has seen a 28% spike in new employees being hired. Putting the pandemic and other factors aside, big companies have increased their capacities and introduced dedicated employees to ensure compliance and conformity with the new regulations.
MDR was rolled out with the aim of promoting strict regulations for the entire life-cycle of a medical device. The focus on General Safety and Performance Requirements covers diverse phases of the medical device life-cycle, which ensures complete protection for the patient receiving care. This regulatory overhaul scared many manufacturers as the additional requirements were seen as a barrier preventing innovation in the EU. The need for clinical studies is seen as a big hurdle for start-ups as it affects their financial strategies.
Indeed, the MDR imposes new and extended requirements, including documenting products’ clinical efficacy (clinical trials). But efficiently managed processes and quality management practices will reduce manufacturers’ burden by relieving them of adverse events and product recalls.
Over all these years, our experts have successfully supported several medical device companies with round-the-clock regulatory support. Be it as an EU AR/PRRC or as their quality compliance partner supporting the implementation of a Quality Management System.
Our aim is to continue supporting medical companies of all sizes and benefit them by being real Regulatory Risk Partners. Our team of experts publish several insights for the industry and are on a mission to make navigation of regulation,
- Easy
- Fast
- Cost effective.
Feel free to connect with our experts by sending an email – mdd@mddltd.com or by filling in an interest form by clicking on this link – https://mailchi.mp/a3744c8d52c0/eumdr
The EU Commission recently published a consolidated version of relevant texts under the EU Medical Device Regulation – which can be accessed by clicking on this link – https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02017R0745-20230320#tocId2
Don’t let Regulations Hold back your Innovation!
Our Experts are right here to be your Regulatory Risk Partner by offering a wide range of services, be it premarket regulatory support, Regulatory Support during commercialisation or complying with post-market regulations.
Connect with our experts by sending an email – mdd@mddltd.com or by filling in an interest form by clicking on this link – https://mailchi.mp/a3744c8d52c0/eumdr