EU MDR
Establishing a regulatory framework for medical devices
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
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.
The device classifications comprise device four categories:
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non-invasive
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invasive medical
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active medical,
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a special category with exceptions including contraceptive, disinfectant, and radiological diagnostic medical devices.
The MDR has additional rules for treatment devices based on nanomaterials. Further, the devices are classified based on risk, which determines the scale of data and depth of evaluation required for the prospective products.
- 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)
Medical Device Classification
Our EU MDR Servicer 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.
CLIENT TESTIMONIALS
We work continuously to receive customer feedback to provide them unmatched value. Here is what they say about us.
“Toby has had a smooth journey with Saraca Solutions. They have provided us with both a highly experienced Quality Manager and a very energetic Quality Engineer. Specifically, I would like to thank Saraca for closing our NCs in a timely manner while simultaneously performing a gap analysis on our entire QMS. Additionally, in preparation for an upcoming ISO audit, Saraca performed an internal audit on all of our major Quality subsystems. Lastly, Saraca Solutions faced our 2017 ISO audit, hand in hand with our staff, at Toby headquarters. I appreciate the end to end support provided by Saraca Solutions. This magnitude of interaction is unique among engineering services companies in the area of medical devices."
"Saraca was extremely helpful to our Product Team’s understanding of the requirements of ISO 13485 by presenting it to them in a simple and effective manner. They have also done a commendable job in helping us to align our deliverables in-line with the ISO 13485 requirements. With their help, our team was able to understand & implement the ISO 13485:2016 requirements effectively within a short duration. Their planning and execution methodology is superb. Overall, we are very happy with the outcome of our association with Saraca Solutions."
“Our team has partnered well with SARACA Solutions as we continue the development process for submitting one of ENT products for 510(k) review with US FDA. They constructed and maintain a Design History. They are also working on Risk Analysis as defined by our Quality Management System. The SARACA team has shown the depth of their experience working in the industry while seamlessly integrating well with us. In addition, their methods of collaboration ensure effectively developing the documentation and processes for our product management.”
