Free Podcast: Q&A session on clinical and regulatory challenges for manufacturers under the EU MDR
Mikaela Dimitriu & Marius Woitok provide in-depth answers to questions posed by JMDR subscribers on the clinical and regulatory challenges for manufacturers under the EU MDR.
In this interview, find out answers to the following questions:
- What are the key changes in relation to running clinical trials for medical devices since the adoption of the EU MDR? Is the MDR already having a noticeable impact on the conduct of clinical trials in Europe?
- Is there a centralised source of information on key requirements for registration of clinical trials for medical devices in the EU Member States?
- What is the definition of a PMCF study, as the MDR does not provide a definition?
- Are there EU form templates, for example for application, notification, financial disclosure, clinical research agreement, etc.?
- Is there a database of EU based CROs (or a CRO association similar to Medtech Europe) where non-EU clinical trial sponsors can find information about EU based CROs?
- Are the EU Clinical Trials Directive 2001/20/EC and the EU Clinical Trials Regulation 536/2014 applicable to medicines only? Do they apply to drug/device combination products at all?
- What are the rules around advertising clinical trials in the EU?
- Annex II to the MDR, which concerns technical documentation, requires a Post-Market Clinical Follow-Up plan and a PMCF evaluation report referred to in Part B of Annex XIV or a justification why a PMCF is not applicable. To what level must the justification of an absence of a PMCF be documented?
- How are manufacturers in the EU managing multiple sources of information and updates to the CER and SSCP? For example, with information coming from the PMCF and PSURs on an annual basis, how are manufacturers best aligning these activities to update their technical documentation?
- This next question relates to “sufficient clinical data” for simple, tool-like surgical Class I instruments like knives, forceps, coagulation electrodes etc. with a very long history of clinical use, and which are being used across a very wide range of indications and procedures. Hardly any clinical data from published studies exist for these kinds of tools. Also, these instruments do not have any benefit on their own but only through their use by trained surgeons. How much data are required per indication, and does the manufacturer need to specify indications at all if there is a universal intended purpose like “cutting tissue”?
- What kind of clinical investigation is necessary for a custom-made device with a new intended use/indication that is placed on the market for the first time after the date of application of the MDR?
- For certain Class III medical devices that are not claiming equivalence and are not legacy devices under the MDR, it may be impossible for them to undergo clinical investigations because they are accessories to a treatment – such as a guidewire, catheter or balloon for a coronary stent implant. How should manufacturers approach this situation?
- What kinds of devices can make use of Article 61(10) and what is the consequence for what can then be claimed in marketing materials? What data remain essential to have when using Article 61(10)?
- Can you provide any tips and tricks on how claims can be formulated to be able to collect sufficient and useful clinical data to support the claims?
- What is the best way to choose good search terms for a literature search?
- What role can registries have in the collection of post-market data and how could these registries be set up in a pragmatic way that enables manufacturers to use the existing data?
- What role can insurance data play in the field of clinical data?
- With an increasing number of devices offering artificial intelligence features, what are the most important aspects from clinical data validation steps for manufacturers to consider for these devices in the absence of any legislation?
