What is European Medical Device Regulation (MDR)?
The European Medical Device Regulation (MDR) is a set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for medical device companies that want to sell their products in the European market. Medical Device manufacturers must develop a suite of MDR-compliant regulatory systems, processes, and documents to continually monitor the safety and performance of their products. The regulation is applicable for a manufacturer, authorized representative, importer, or distributor of medical devices in the EU.
MDD VS. MDR
Medical device classification
MDD VS. MDR
We have to remember that the MDD was a directive, which countries had to integrate into their national legislative policies. However, the MDR is a regulation that member states have to directly apply without any successive integration process into their national law. As with the earlier MDD, Conformity Assessments remain the major regulatory hurdles that manufacturers have to prepare for. The Conformity Assessments will be evaluated by the Notified Bodies, which are agencies designated by the member states of the EU, as was being followed under the MDD. According to the MDR, the functional significance of the Notified Bodies is drastically revamped and only a few Notified Bodies are being retained from MDD.
Medical device classification
The device classifications comprise device four categories:
- non-invasive
- invasive medical
- active medical,
- a special category with exceptions including contraceptive, disinfectant, and radiological diagnostic medical devices.
- Class I – Provides non-sterile or do not have a measuring function (low risk)
- Class I – Provides sterile and/or have a measuring function (low/medium risk)
- Class IIa – (medium risk)
- Class IIb – (medium/high risk)
- Class III – (high risk)
Our service offerings
- EU MDR - GAP Assessment
- CE Certification Strategy
- Notified Body support
- Virtual MDR training
- Identifying the submission process in Europe
- Clinical Evaluation Report (CER)
- Post Market Clinical Follow-up (PMCF)
- Summary Technical Documentation (STED) creation and development
The stringent development process of medical devices and the need to address new regulatory requirements to obtain Notified Body approval, is likely to make the transition a complicated and time-consuming process. Moreover, currently approved devices are not exempt from the requirements of the new regulation and will need to be re-evaluated and re-approved.
We have experts to help manufacturers of currently approved devices to plan the steps towards MDR certification. Good preparation and early action will be key to ensuring a smooth transition to the new requirements and we are here to help you.
