What is MDR 2017/745 Compliance?
MDR 2017/745 Compliance Definition
Medical device regulation (MDR) 2017/745 is the latest set of regulations that govern the clinical investigation, production, and distribution of medical devices in Europe. This regulation applies to medical devices that come into direct contact with humans (e.g., bandages, catheters, implants). Compliance with this regulation is mandatory for medical device companies that want to sell their products in the European marketplace. MDR 2017/745 went into effect on May 26, 2021 and replaces the EU’s previous Medical Device Directive (MDD) and Active Implantable Medical Devices Directive.
Under this new regulation, some medical devices will have stricter oversight by notified bodies, and manufacturers will need to provide more in-depth clinical data to demonstrate their safety and performance claims. In addition, the classification for some medical devices (i.e., Class I, IIa, IIb, or III) will change. Devices that meet the requirements of the regulation will receive a CE Mark.
FAQs
What is MDR certification?
The MDR certification process involves the following steps:
- Assign a person responsible for regulatory compliance from your organization.
- Classify your medical device according to the regulation. The classification of your medical device will determine the conformity assessment route that is needed.
- Implement a quality management system (QMS) to manage the design and development of your medical device, as well as your quality processes.
- Prepare the necessary documentation for your technical file, as outlined in the MDR. This includes product description and specifications, manufacturing information, risk management plan, product verification and validation, clinical evaluation and post-market surveillance reports, and labeling.
- Appoint an authorized representative to act on your behalf if your company resides outside of the EU.
- Undergo an audit by a designated notified body. The notified body should be accredited by European competent authorities to conduct the assessment. A complete listing of designated notified bodies is maintained in the NANDO database.
- Once your pass your audit, obtain CE marking and ISO 13485 certificates from your notified body.
- Prepare a Declaration of Conformity, which states that your device complies with the appropriate EU regulation.
- Register your medical device and the unique device identifier in the EUDAMED database.
- All technical files, post-market surveillance reports, and other activities must be updated regularly.
Source: https://www.emergobyul.com
What is EUDAMED?
EUDAMED is a database that will be used to track the safety and performance of medical devices in accordance with the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR). EUDAMED, or the European database for medical devices, is a key component of Europe’s new medical device and IVD regulations.
Source: https://www.emergobyul.com
Cost Savings Calculator
Delivering new products to market is challenging. And it is difficult to see the cost impact of one or more mistakes.
Try our calculator to estimate the impact on your business. Input your business details, select a challenge, and see the real-world cost impact as validated by our customers.