TU Dublin supports medical device industry meet new regulatory challenges
Developed in partnership between SGS Ireland and TU Dublin, the accredited postgraduate programme is helping the medical device industry meet new regulatory challenges.
SGS is a world-leading testing, inspection and certification company, recognised as the global benchmark for sustainability, quality and integrity. It's 98,000 employees operate a network of 2,650 offices and laboratories.
The new EU Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR) apply to all businesses marketing medical devices in the EU and introduce significant new requirements and added complexity to the regulatory regime. While these regulations aim to improve patient safety and ensure the effectiveness of medical devices, they have also introduced additional complexity and requirements for manufacturers and Notified Bodies involved in the certification process.
New regulations require increased skills capacity
The challenge has been exacerbated by a shortage of skilled compliance professionals within the industry and a marked reduction in Notified Bodies in the field.
“In putting the regulation in place, there wasn’t sufficient recognition of the increased skills capacity required by the new regulations. It is now evident that there is a very serious skills shortage and this has contributed to the extension of implementation dates”, explains Jane Massy of SGS.
In putting the regulation in place, there wasn’t sufficient recognition of the increased skills capacity required by the new regulations. It is now evident that there is a very serious skills shortage and this has contributed to the extension of implementation dates.
Jane Massy of SGS
SGS Ireland worked with TU Dublin to develop a solution to this shortage, in the form of a European Qualification Framework (EQF) accredited module, aimed at equipping industry professionals with the competencies to meet the requirements of the new regulations.
SGS brought its experience as an established Notified Body (SGS Belgium NV – Notified Body 1639) and training provider to bear while the TU Dublin School of Chemical and BioPharmaceutical Sciences accredited the programme leading to a five credit certificate in Implementing Regulatory Requirements for Medical Devices at Level 9 in Ireland which equates to Level 7 EQF.
The collaboration was brokered by the Enterprise Academy, a dedicated unit at TU Dublin that supports the development of interdisciplinary programmes, working with faculty and organisations of all sizes across key sectors intent on attracting, engaging and retaining the best and brightest of talent.
University / Industry collaboration co-creates accredited solutions
From early on, SGS anticipated the need to help the industry prepare for the implementation of the new regulations and had been developing a programme. “We worked with TU Dublin to accredit this provision as a Level 9 (Ireland) Continuing Professional Development qualification,” Jane adds. “The online programme, delivered over 10 weeks, is designed to help people in the industry understand and implement these complex new regulations.”
SGS worked with TU Dublin to accredit this provision as a Level 9 (Ireland) Continuing Professional Development qualification. The online programme, delivered over 10 weeks, is designed to help people in the industry understand and implement these complex new regulations.
Jane Massy of SGS
Prof Anne Greene leads the Pharmaceutical Regulatory Science Team (PRST) at TU Dublin and worked with SGS on the accreditation of the programme. “Jane Massy had experience of working to support industry / academic collaboration on similar programmes prior to joining SGS when she was invited to sit on a Business Faculty programme accreditation panel. This allowed her to see TU Dublin’s agility and ability to work successfully with industry on accredited learning and talent development programmes. So, when SGS approached us about this programme, there was already a relationship to build on.”
The proposed programme aligned with established expertise within the university. “We already have a Master's programme in pharmaceutical quality assurance, so the collaboration with SGS was a natural fit to expand our learning pathways for professionals in medical device regulation,” says Prof Greene.
We already have a Master's programme in pharmaceutical quality assurance, so the collaboration with SGS was a natural fit to expand our learning pathways for professionals in medical device regulation.
Professor Anne Greene, TU Dublin
It was decided at an early stage that the new programme would be at Level 9. “Most of the people working on compliance in the industry already have an undergraduate degree,” she notes. “This made a Level 9 Certificate appropriate.”
Work began on the development of the programme in 2021 and was finalised and accredited in early 2022. The TU Dublin accreditation panel included academics from within the university, industry representatives and external academics.
Two successful pilots were run in 2022 and the first programme was delivered from May-August 2023. This first full programme coincided with the start of an EU-funded project, NoBoCap, which includes SGS and TU Dublin as partners. This project enabled the programme to be more widely rolled out across the EU, as the participant fees can be covered by the EU Funding until February 2026.
Key features of this course include:
- 10 weeks (8 in the virtual classroom, 2 for online assessments)
- 100% online
- Postgraduate CPD certificate worth 5 credits
- Accredited by Technological University Dublin (TU Dublin)
- Led by Dr Geofrey De Visscher, Head of SGS’s European MDR Notified Body (NB)
The impact - benefits to the medical device industry and people working in it
Programme participant Valerie Byrne, a Quality Assurance Associate with Cosmo Pharmaceuticals, has no hesitation in recommending the programme to other industry professionals. “I have already recommended it to colleagues,” she says.
“The course was brilliant. Each section linked seamlessly to the next and prepared you. We had work assignments to complete each week and I learned a lot from those. I refer back to the course notes regularly, especially those on Clinical Evaluation.” The content was pitched at an accessible level, she adds. “It was very clear and not overly complicated. Anyone can read guidelines, but I preferred to do a course that would walk me through the process, and I continue to go back and refer to the programme materials. It will 100 percent help me in my future career.”
Prof Greene explains how the new programme offers benefits to the medical device industry and people working in it, to SGS, and TU Dublin. “We made sure at the outset that the programme would benefit both partners. It was clear that SGS was able to bring expertise that we didn’t have, while we could offer the accreditation required for the programme.”
We made sure at the outset that the programme would benefit both partners. It was clear that SGS was able to bring expertise that we didn’t have, while we could offer the accreditation required for the programme.
Professor Anne Greene, TU Dublin
As a result, SGS can now offer a programme accredited by TU Dublin, Ireland’s largest technological university, the industry has access to the training required to meet the exacting new requirements of the MDR and IVDR, while industry professionals gain CPD credits and a Level 9 Certificate in Implementing Regulatory Requirements for Medical Devices.
As noted above, since March 2023, this partnership has received European funding through the success of an EU4Health consortium funding application to meet the significant need for the expansion of Notified Body Capacity (NoBoCap).
For more on the MDR Postgraduate Course
Understanding MDR with respect to the creation and assessment of the full Technical Documentation and the Clinical Evaluation Report is crucial for Medical Device manufacturers.
These courses will support enterprises on the journey to MDR compliance. Graduating may also be the first step to a potential career as an Notified Body auditor and/or product assessor.
The final award is a CPD certificate in Implementing Regulatory Requirements for Medical Devices, awarded at NFQ IRL Level 9 and EQF Level 7 without classification, accredited by TU Dublin.
This programme is available free of charge to the industry for the next three years, with plans to develop six additional modules. This expanded collaboration incorporates the TU Dublin School of Mechanical Engineering and School of Chemical and BioPharmaceutical Sciences, with ongoing support from the Enterprise Academy.
