Medical Device Regulation (MDR)
Certification Experts as your full-service compliance partner
As a manufacturer of Medical Devices, you will have to check whether the product you want to market falls under the MDR (Regulation for Medical Devices). If this is the case, you will have to take into account that the requirements are stricter than the previous MDD guidelines. That includes stricter prior checks for high-risk devices, stricter designation requirements, and the requirements of monitoring procedures for tracked claims, and implementing a risk classification system for new medical devices and for in vitro diagnostics. Certification Experts can be your full-service compliance partner, and our team with over 25 years of experience can provide expert MDR consultancy services.
Trust our team of experts to handle the MDR compliance for you
MDR meaning: what is it?
Since May 26, 2021, the MDR 2017/745 – the regulation for medical devices – has come into effect. Previously, the Medical Devices Directive 93/42/EEC (MDD) was in force, so the Medical Device Coordination Group (MDCG) has drawn up guidelines to make the transition to the Medical Device Regulation manageable. These MDR European Commission guidelines are not legally binding but support uniform application of the Medical Device Regulation. Based on these guidance documents, the Certification Experts team can help you implement the changes:
|More medical devices are subject to the new regulation due to the redefinition of the term ‘medical device’ & stricter classification MDR.
|Our experts can classify your product so you will know whether the Medical Device Regulation applies to your medical device, and if so, under which Classification Rule and in what Risk Class it should be classified.
|The General Safety and Performance Requirements (GSPR) have been expanded.
|We support you in achieving compliance with these requirements and offer MDR consulting services based on harmonised standards so you will be able to demonstrate that your product meets the safety and performance requirements of the MDR.
|Implementation of a ‘Unique Device Identifier’ (UDI) has become mandatory.
|Our team can supervise a correct implementation of the UDI for you.
|Requirements for the Quality Management System (QMS), Clinical Evaluation and Post Market Surveillance (PMS) have become stricter.
|We can help implement and set up an appropriate QMS from start to finish, guide the clinical evaluations and the handling of the PMS.
|It has become mandatory to register both the manufacturer and their products in EUDAMED, a European database.
|We can assist you with registering yourself and your medical devices in the Eudamed database.
|It is mandatory for all manufacturers whose products fall within the MDR 2017/745 to affix a CE mark before these products can be placed on the European market. The admission requirements vary per risk class.
|Our expertise lies in guiding the CE marking process based on the conformity procedure for your products. CE marking process for medical devices to learn more about this process.
If you would like to know more, Certification Experts can evaluate your current certification and provide expert MDR consultancy services. This is done through the following steps by our experts:
- A legal classification of your device to determine applicable legislation and the correct Risk Class under MDR
- A GAP analysis of your current Technical Documentation to determine the Route to Compliance
- Supporting and guiding services to help you draw up the Technical Documentation meeting the regulatory requirements
What are the ISO regulations for medical devices?
There are several ISO standards for medical devices. The most commonly applied standards are 14971, 10993, 62304, 9001 and 13485 (QMS), 14155 (Clinical Investigation), and 60601 (Medical Electrical Equipment).
Full-service MDR compliance
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MDR compliance & certification
Thus, to be in compliance with the Medical Device Regulation, you will have to comply with all stricter rules that have been drawn up to replace the previous MDD regulation. This means, among other things, that you must draw up a technical CE file, implement a quality management system and, if your product falls into a higher risk class, obtain a CE certificate in order to be able to market your products. The medical device regulations will make the market more transparent and are supposed to make it more difficult to trade unsafe medical devices. This way, the MDR legislation protects the safety of medical devices for end users (patients). Certification Experts can help you set up a technical CE file and quality management system, allowing you to place your medical devices on the European market.
MDR guidance from start to finish with Certification Experts
In addition to our MDR consulting services, our experts can also offer you active guidance in the processes and actions required by the Medical Device Regulation, such as:
- Setting up a UDI system
- Writing a clinical evaluation report
- Offering support with Risk Management and possible safety performance testing
- Designing labels and manuals
- Setting up a documented Quality Management System (QMS)
We will start with classifying your product, so that we can determine what the conformity process will look like for you based on this. With our expertise, we can rework this lengthy and extensive process with many different steps into a clear and efficient process for you. With Certification Experts as your Full-service Compliance partner:
- You have accelerated access to the EU market through our CE certification process
- You will be guided by a team of Medical Device experts
- You will work with a trusted party with 2000+ satisfied customers
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