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A few months ago, Modis Life Sciences followed the Regulatory Affairs Professionals Society (RAPS) Convergence, which was Live online due to Covid-19. As Modis Life Sciences is active in the regulatory landscape, this was a great opportunity to see what is going on in the industry and to search for new horizons, together with other regulatory professionals, regulators, scientists, and innovators. With the changes from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) interesting topics on medical devices were discussed.
Here are the top 5 learnings concerning medical devices, after four days of following the convergence and 6 session a day:
- With different drug/device combinations, choosing the correct category is very important in defining the process that needs to be followed. When applying to a Notified Body (NB) you need all level of detail, the NB do not trust, which means, everything needs to be verified. Most of the questions raised by the Notified body were questions concerning quality.
- Manufacturers should be cautious of their risk management; this could have impact on the classification.
- The risk management process should be perceived as a continuous iterative process throughout the entire device lifecycle.
- Safety for your company = Safety for the patient.
- Post-market surveillance (PMS) is very important and a continuous process that should not be forgotten.
- Article 88 of the MDR 2017/745 requires manufacturers to submit a trend report for non-serious incidents and expected undesirable side-effects. If these events occur with a statistically significant increase in the frequency or severity, they will have to be evaluated against the benefit-risk analysis to determine if reporting is required.
- Statistical methods should be included.
- Competent authorities may conduct their own assessments on the trend reports and can require the manufacturer to adopt appropriate measures.
- It’s important to scan the landscape of information that is available, to know what can be included in the Clinical Evaluation Report (CER).
- The Clinical Development Plan (CDP) is part of the Clinical Evaluation Plan (CEP) and should not be seen separately.
- The CER should be a stand-alone
- Sufficient clinical evidence = quantity + quality and the result of a qualified assessment that has reached the conclusion that the device is safe and achieves the intended benefits.
- Medical Device SoftWare (MDSW) ≠ Software As Medical Device (SAMD)
- SAMD is a stand-alone software.
- where MDSW can also be hardware.
- It is important to differentiate to understand the requirements.
The topic of the sessions RAPS can vary a lot, from very broad to very specific. The RAPS EURO Convergence 2021, 10-12 May, will also be an entirely virtual programme and will focus on the latest information in Medical Devices (22 sessions), IVD (11 sessions), and Pharma (12 sessions). We hope you are as excited as us, to see a big focus on medical devices!
With all the change, Modis Life Sciences can assist you with taking the first steps. The determination if your device falls under the MDR or IVDR and if so, to which category it should be assigned. Let’s meet during one of the many question rounds!
– Alicia Serck, Project Manager