March 21, 2018
Clinical Investigations – What changes because of the Medical Device Regulation?
Does the MDR change your Clinical Investigations?
April 5th 2017 was a historical moment for the medical device industry: the Medical Device Regulation (MDR) was adopted by the European Union. Beginning May 27th, 2020, after a 3 year transition period, this regulation will be the gold standard for the medical device industry. The big question is: how will this influence the conduct of clinical investigations with medical devices? Here, we will guide you through the most important changes from the current regulations.
What current standards are amended or replaced by the MDR?
For medical devices, the MDR officially replaces the Active Implantable Medical Device Directive (AIMDD, Council Directive 90/385/EEC) and the Medical Device Directive (MDD, Council Directive 93/42/EEC). However, as we will outline below, the MDR also includes various sections that are closely aligned with ISO 14155:2011 – Clinical Investigation of Medical Devices for human subjects – Good Clinical Practice and the Declaration of Helsinki.
Which sections of the MDR focus on Clinical Investigations?
A simple word count in the MDD and the MDR shows that there is a lot more focus placed on clinical investigation in the MDR.
When analyzing the MDR for information on clinical investigations, you should refer to Chapter VI – Clinical Evaluation and Clinical Investigations, specifically sections 62 – 82. These sections guide you through the procedures for preparing an application for your investigation at the Member States of the EU (in daily practice mainly referred to as Competent Authorities). Additionally, it provides the general compliance requirements for your investigation. Annex XV guides you through the details of your application to the Member States and other obligations for a Sponsor of clinical research with medical devices.
Main differences of MDR with current standards
Now that you know the background, we can go focus on the main differences with the AIMDD and the MDD, and how ISO 14155:2011 and the Declaration of Helsinki relate to the MDR.
After a gap analysis of the MDR to these standards, the primary conclusions are:
– The information provided in Chapter VI of the MDR is not new, all is also described in either ISO 14155:2011, Declaration of Helsinki, MDD or AIMDD.
– The MDR has a strong focus on Personal Data Privacy, aligned with the General Data Protection Regulation* (GDPR 2016/679) coming into force on 25 May 2018. This means that if your company is preparing an update to the quality system to be compliant with the GDPR, you are also preparing for the transition to the MDR in 2020.
– The MDR is designed for the digital world. This means that the MDR often refers to the use of a new centralized European Electronic System (called EUDAMED) for the registration of clinical trials, application and review by Member states of the clinical investigation, reporting of safety events, submission of results, etc. As several countries already use electronic systems, this will merely make life easier because these systems will be combined and centralized (i.e. one application is sufficient instead of multiple separate systems/procedure for each separate Member State).
– Having this Electronic System in place will also allow the individual Member States to work together! The MDR describes the collaboration of Member States at several levels, including the review of applications and decisions with respect to safety evaluation. Effective May 2027, there will be one Coordinating Member State that coordinates the review of all applications and reports being submitted. Individual Member States still will be involved in the review, but only within set time frames. This results in a better defined period of application review: 55 days, although exceptions exist.
– The MDR outlines the minimal requirements for a pre-market clinical investigation. Similar to the ISO 14155:2011, describing the application requirements for Ethics Committees, the MDR has published a list of documents for Member State applications in Annex XV.
– As of the date the MDR comes into force, Member States should be notified about the conduct of all post-market studies. This is a new requirement, as the current standards only require submission for pre-market trials.
“For stakeholders that perform clinical investigations and want to prepare for the MDR: Ensure your Quality System is compliant to the MDD/AIMDD, ISO 14155:2011 and Declaration of Helsinki” Leonie van de Kamer – Factory CRO
Conclusion: what changes for clinical investigations?
Comparing the MDD and the MDR the requirements how to conduct a clinical investigation do hardly change (or do not change at all). This is good news for stakeholders that already perform clinical investigations in the medical device industry. Provided that your current Quality System is compliant to the MDD/AIMDD, ISO 14155:2011 and Declaration of Helsinki, there is not much to change. Mainly due to centralizated electronic system, the MDR might even make everything easier for conducting clinical investigations! The even better news is that FDA just published their view on ‘global data’ and the conditions when they will acceptance of ‘foreign’ clinical data. This opens up the possibility of doing one trial in multiple countries. A Factory CRO blog on this topic can be found here.
One caveat to all this good news. There is talk that the ISO 14155:2011 is currently under review and an update is expected in 2020. Hopefully, this update will be aligned with the MDR.