As of May 25th 2017, the European Medical Device Regulation (EU MDR) has replaced the long-standing Medical Device Directive (MDD). The impact of the Medical Device Regulation (MDR) to the medical device industry is substantial as it requires the re-classification and re-registration of all medical devices currently on the market.
1)More medical devices will require clinical investigation;
2)Equivalence will be harder to demonstrate;
3)The level of evidence required for medical device studies will be higher
4)There will be more focus on post-market surveillance.
What does it mean for you
It also means you will need to do a conformity assessment for all your devices currently on the market, be it a syringe or a pacemaker, or remove the product from the market. Additionally, more products will be considered to be a medical device.
Make sure you are well informed about the new classifications and corresponding clinical requirements of your products as per new Medical Device Regulation (MDR).
In addition, the manufacturer needs to demonstrate it has access to the equivalent device data, which significantly limits its usability. These criteria were also added in the most recent revision of the guidance on the clinical evaluation (MEDDEV 2.7.1 rev.4).
Where medical device clinical studies previously aimed to demonstrate safety and performance, studies under the EU MDR will now also need to show the clinical benefit to patients. This means that clinical trials should be designed with completely different end-points, more complex study setups, and potentially larger sample sizes. Additionally, clinical investigation plans should include details on prevention of scientific bias.
A PMS system shall be used to actively gather and analyse data on the quality, performance, and safety of the device throughout its lifetime. The system should be based on a PMS plan and to be outputted in a report. In addition Class II and III devices should prepare yearly for periodic safety update reports (PSUR) containing the analyses of the PMS data gathered, including data from post-market clinical follow-up.
Regulation (EU MDR) is necessary, particularly in a sector, like the Medical device sector, which exposes countries and people to a risk.
The MDR will significantly increase clinical data requirements for your company.
Processing New Clinical Data Benefits
|Traditionally, companies have relied on Literature search routes to demonstrate the clinical safety and performance of the device in market and demonstarted equivalence with availabe CE marked device in market. The MDR will significantly increase clinical data requirements for your company. Clinical data collection should be compliant with Good Clinical Practice (GCP), such as set out under ISO 14155.
GCP requires informed consent, patient privacy protection, and safe data-processing. This has further intensified the need of Post market clinical follow-up (PMCF), PMS and PSUR data collection.
Implementation of the EU MDR can be complex and challenging. As you implement, it is important to understand if your plan is going in the right direction, or not.
| Until now, different European countries have interpreted and Stricter pre-market control of high-risk devices at an EU level
The inclusion of certain aesthetic products which present the same characteristics and risk profile as equivalent medical devices.
A new risk classification system for diagnostic medical devices based on international guidance.
Improved transparency through the establishment of a comprehensive EU database of medical devices (Eudamed).
Device traceability through the supply chain from its manufacturer through to the final user,
An EU-wide requirement for an ‘implant card’ to be provided to patients containing information about implanted medical devices.
The reinforcement of the rules on clinical data and clinical studies on devices.
Manufacturers to collect data about the real-life use of their devices.
Improved coordination between EU Member States implemented the directive in different ways. By revising the directive EU MDR will enforce.