Frequently Asked Questions
Find answers to common questions about medical device certification, MDR compliance, ISO 13485, and CE marking.
Navigating the regulatory landscape for medical devices can be complex. Below you will find answers to the most frequently asked questions from manufacturers about MDR certification, ISO 13485 quality management systems, and the CE marking process. If your question is not answered here, please do not hesitate to contact our team directly.
MDR (EU) 2017/745
Frequently Asked Questions
What is the Medical Device Regulation (MDR)?
The Medical Device Regulation (EU) 2017/745 (MDR) is the European regulation governing the production and distribution of medical devices in the EU. It replaced the Medical Device Directive (MDD) and sets higher standards for clinical evidence, post-market surveillance, and traceability.
When did the MDR come into full effect?
The MDR became fully applicable on May 26, 2021, replacing the previous Medical Device Directive (MDD 93/42/EEC). Manufacturers must ensure their devices comply with MDR requirements to maintain EU market access.
What is a Notified Body under MDR?
A Notified Body is an organization designated by an EU Member State to carry out conformity assessment activities under the EU MDR. Whether a Notified Body is required depends on the classification of the medical device and the applicable conformity assessment procedure..
Which medical devices require MDR certification?
All medical devices placed on the EU market must comply with MDR. Devices classified as Class IIa, IIb, and III require conformity assessment by a Notified Body. Class I devices can be self-certified but must still meet MDR requirements.
How long does the MDR certification process take?
The MDR certification timeline varies depending on the device classification and complexity. Typically, the process takes 6-12 months for Class IIa devices and 12-18 months for Class IIb and III devices, including technical documentation review and quality management system audits.
ISO 13485
Frequently Asked Questions
What is ISO 13485?
ISO 13485 is an internationally recognized standard for quality management systems (QMS) specific to the medical device industry. It outlines requirements for organizations involved in the design, production, installation, and servicing of medical devices.
Is ISO 13485 certification mandatory?
While ISO 13485 is not always legally mandatory, it is practically required for medical device manufacturers seeking EU market access. MDR requires manufacturers to have an appropriate quality management system, and ISO 13485 is the recognized standard for this purpose.
How long is an ISO 13485 certificate valid?
An ISO 13485 certificate is valid for 3 years. During this period, surveillance audits are conducted annually to ensure continued compliance. A recertification audit is required before the certificate expires.
What is the difference between ISO 13485 and ISO 9001?
While both are quality management system standards, ISO 13485 is specifically designed for the medical device industry and includes additional requirements for risk management, design controls, and regulatory compliance. ISO 9001 is a general-purpose quality management standard.
Can US manufacturers get ISO 13485 certification?
Yes, US manufacturers can obtain ISO 13485 certification from accredited certification bodies like Udem Atlantic. This certification demonstrates quality management compliance and is often required for EU market access and recognized by many other regulatory authorities worldwide.
CE Certificate
Frequently Asked Questions
What is a CE certificate for medical devices?
A CE certificate (also known as an EC certificate under MDR) is a document issued by a Notified Body confirming that a medical device meets the essential requirements of the applicable EU regulation. It allows manufacturers to affix the CE mark and sell their devices in the European Economic Area.
What is the difference between CE marking and FDA approval?
CE marking indicates conformity with EU regulations (MDR) and is required for the European market, while FDA approval/clearance (510(k) or PMA) is required for the US market. The regulatory pathways, clinical evidence requirements, and post-market obligations differ between the two systems.
How much does CE certification cost?
The cost of CE certification varies significantly based on the device classification, complexity, and the manufacturer's readiness. Costs include Notified Body fees for conformity assessment, quality system audits, and technical documentation review. Contact us for a customized quote.
Can a US company obtain CE marking for their medical device?
Yes, U.S. companies can obtain CE marking for their medical devices. They need to appoint an EU Authorized Representative where applicable, ensure compliance with the EU MDR requirements, and complete the applicable conformity assessment process.
How long does it take to get a CE certificate?
The timeline for obtaining a CE certificate depends on the device risk class, the completeness of technical documentation, and the quality management system readiness. On average, the process takes 3-6 months for lower-risk devices and 12-18 months for higher-risk devices.