Is your life science organization working toward EU Medical Device Regulation (MDR) readiness?
If you are a manufacturer, authorized representative, importer or distributor of medical devices in the EU, you will need to know how to comply with the MDR. But you still have some time. In light of the COVID-19 pandemic, the European Commission announced that it intends to postpone the application date for EU MDR from May 2020 to May 2021.
In pursuit of EU MDR compliance, many organizations have begun to construct an EU MDR checklist. In short, this document outlines the exact procedures that the organization must follow to comply with these standards. In this scenario, it's essential that your organization invests in an enterprise quality management system (eQMS) that fulfills EU MDR requirements and delivers on checklist items.
EU MDR Checklist: 5 Essential Steps to Include
What are the essential EU MDR checklist tasks?
As an industry-leading quality management software provider, we've seen firsthand how an EU MDR checklist can deliver greater preparatory value to life sciences and medical device manufacturing organizations.
With that in mind, here are the five essential steps that you must include in your EU MDR Checklist.
1. Update Post-Market Surveillance Program
EU regulations require medical device manufacturers to develop a post-market surveillance program. Annex III of the MDR 2017/745 shall address the collection and utilization of available information including:
- Information concerning serious incidents, including information from PSURs
- Records referring to non-serious incidents and data on side effects
- Information from trend reporting
- Relevant specialist or technical literature, databases and/or registers
- Feedback and complaints provided by users, distributors and importers
- Publicly available information related to similar devices
When done correctly, your post-market surveillance system can improve your medical device, providing a better service to users while mitigating risk proactively.
2. Prepare for Unique Device Identification
The Unique Device Identification (UDI) is the "barcoding" of all medical devices in the EU. The UDI will be publicly available to users and regulators in need of information related to the product/service. UDI is a basic obligation of all medical device manufacturers in the EU.
As to the timing of the introduction of the basic UDI required for the documentation: Any Manufacturer wishing to comply with the new EU MDR can and should develop the basic UDI for their device without delay. As the UDI will be required for the new Technical Documentation (Annex II), for the new EU Declaration of Conformity (Annex IV) and for the new registration data (Annex VI, Part A).
3. Assign EU PRRC
The EU Person Responsible for Regulatory Compliance (PRRC) is the designated employee with regulatory expertise. The PRRC is responsible for proper EU MDR compliance, ensuring that the technical documentation and EU declaration of conformity are drawn up and updated regularly. Additionally, the PRRC ensures that post-market surveillance obligations are documented.
This mandate depends largely on the size of your organization. An exception can be made for small manufacturers with fewer than 50 full-time employees globally and under 10 million in global sales revenue annually.
4. Update Agreements with EU Importers and Distributors
An important focus of the new EU MDR is that the distribution chain for medical devices must follow a sound system of checks and balances. As such, importers and distributors must verify that the manufacturer is in compliance with EU MDR. Moreover, importers and distributors may need to implement a QMS using ISO 13485:2016.
Additionally, according to Article 13.3 "importers shall indicate on the device or on its packaging or in a document accompanying the device their name, registered trade name or registered trademark, their registered place of business and the address at which they can be contacted."
In light of EU MDR requirements, manufacturers will need to update contracts if the agreement extends beyond May 2021.
5. Invest in a Reputable eQMS
Finally, consider leveraging a reputable eQMS. An eQMS system will make or break your quality management process and compliance with new EU MDR requirements. In fact, it can be the difference between a drastic improvement in product development, quality, customer relationships, and more. As a result, the process of identifying the right eQMS must be intentional and strategic.
Here are some helpful resources to guide your decision process:
- The Best QMS Software: The Pros and Cons of the 5 Top Options
- The Top 5 Cloud-Based Quality Management System Options
- Life Sciences Quality Management System: 5 Must-Have Features
Kickstart EU MDR Readiness with Qualio
The fastest-growing medical device and pharmaceutical companies are using a quality-driven approach to accelerate growth. These businesses demand a sophisticated and secure quality management platform with the flexibility to support new and evolving needs across the life science ecosystem.
Moreover, in the face of EU MDR regulations, software must align with new and evolving compliance requirements. To kickstart your EU MDR readiness, we recommend downloading our free guide: The EU MDR Checklist: Everything You Need to Know in 2020.