Are you wanting to know more about the EU MDR conformity assessment process and procedure? Learn more about conformity assessment here.
Do you manufacture or use medical devices sold in the European Union (EU) market? If so, are you in compliance with the EU Medical Devices Regulation (EU MDR)?
The COVID-19 pandemic caused an EU MDR delay in implementation. But as of 26 May 2021, the regulation is now in effect for medical devices. The start date for in-vitro medical devices standards was extended to May 2022. Keep reading to learn about the EU MDR conformity assessment process and procedure.
Overview of the EU MDR Regulation
The EU MDR regulation serves to modernize and improve the quality of medical devices. It defines who must comply and which products are subject to conformity standards. It also divides medical devices into classes based on their risk level.
Who Must Comply?
The EU MDR applies to parties involved with manufacturing to using medical devices. must follow the EU MDR. Manufacturers are required to meet the “General Obligations”. This shows that you have a compliant quality management system (QMS). The QMS defines how you meet quality standards throughout the device’s lifecycle. Conformity assessments will examine the implementation of the QMS via documentation. It is also important to document procedures for device storage and post-market surveillance. The assessment will also test your risk assessment for existing and new devices.
The term “medical device”, according to MDR, encompasses various medical items. This includes an apparatus, appliance, implant, instrument, material, reagent, software, or another article. These items must be used for one or more of the following:
- Preventing, diagnosing, treating, tracking, or alleviating disease
- Diagnosing, treating, tracking, or alleviating disability or injury
- Investigating, modifying, or replacing pathological, anatomical, or physiological processes
- Examining human body samples to collect data
Some products now need a Conformitè Europëenne (CE) marking. Examples include medical cleaning, disinfecting, and sterilization devices. This may involve the use of immunological, metabolic, or pharmacological methods. This applies to in-vitro-diagnostic medical devices and their accessories as well. Some aesthetic items are covered such as colored contact lenses or liposuction equipment.
EU MDR establishes four risk classes for medical devices. They’re divided as follows.
- Class I: low risk
- Class IIa: medium risk
- Class IIb: medium to high risk
- Class III: high risk
The conformity assessment procedure varies based on the risk class. Medium to high-risk devices require more extensive testing and documentation.
The EU MDR Conformity Assessment Procedure
The assessment evaluates your QMS. The specifics of the assessment depend on the risk category of your devices. Annex I requirements address general safety and performance. Annex II examines your technical documentation. Annex III evaluates your post-market surveillance technical documentation. The new directive also includes 22 classification rules in Annex IX. Notified bodies play a role in some of these rules. A notified body describes an EU country-designated organization that evaluates conformity. They follow legislative rules and serve as a third party when needed. The EU MDR regulations include the following standards:
- Strict pre-market scrutiny of high-risk devices
- Notified body adherence to device designations and processes
- Risk profiles for specific aesthetic devices equal to medical devices
- International guidelines alignment for new in vitro diagnostic medical device risk classification
- Increased transparency by using the EU database with unique medical devices identifiers
- Ensuring all patients receive an “implant card” with device information
- Reinforcement of EU-wide coordinated procedures for certifying multi-center clinical trials
- Strict adherence to post-marketing device surveillance
- Increased coordination efforts among EU countries promoting vigilance and surveillance
A 26 May 2021 Press Release emphasized the reasons for the EU MDR’s stronger rules. The goal is to improve the safety, quality, and reliability of medical devices. For example, high-risk items such as implants now need a pre-market review by a pool of EU experts. Required increased user-friendly and detailed labeling and electronic manuals will help users.
Benefits of Working with a Regulatory Consulting Company
Meeting all the EU MDR standards can become an overwhelming task. Partnering with a regulatory consulting company provides the expertise you need. They’re well versed in the regulatory criteria and can explain and apply them to your industry. Their services include tracking new medical devices at every stage of development. They test adherence to the EU MDR standards. These stages include:
- Concept design
- Preclinical evaluation
- Post-market surveillance
These specialists understand all aspects of compliance analysis and documentation needs. They’re also well versed in the various regulation in different countries. If you are importing or exporting to or from outside the UK, you may need to follow more rules. The consultant will help with this process. Besides product development, these experts have other skills to meet regulatory criteria. You can request research, data collection, technical writing, legal documents, and technology. Consulting agents have broad experience in communicating with different departments. They'll also help coordinate information dissemination and task completion. You may find it surprising that consultants can help with FDA Pre-Submission (Q-sub). They complete premarket approval forms and provide guidance on registering and listing devices. Hiring a regulatory consulting company saves you time and ensures high-level compliance.
Are You Ready for an EU MDR Conformity Assessment?
If you are unsure about your business's compliance with the new EU MDR standards get help. Trinity M Consulting, LLC proudly partners with medical device industry clients. We specialize in Global Regulatory Affairs and we are involved from product development to product launch and post market support.
Our services include technical writing and EU MDR guidance and documentation. We develop regulatory strategies, write-ups and submissions to US and EU, in addition to post-market surveillance support. Let us serve as content experts for your EU MDR needs. Contact us today and request a free consultation.