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).
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:
| New guidelines | Our solution |
| More medical devices are subject to the new regulation due to the redefinition of the term ‘medical device’ & stricter classification of the Medical Device Regulation in the EU. | 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 regulation for EU 2017/745 on medical devices to affix a CE mark for medical devices 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
For more information regarding the Medical Devices Regulation (MDR), please use our contact form or contact one of our experts directly on tel: +31 (0)85 007 3210.
What are the ISO regulations for medical devices?
There are several ISO standards for medical devices. The most commonly applied standards are ISO 14971, 10993, 62304, 9001 and 13485 (QMS), 14155 (Clinical Investigation), and 60601 (Medical Electrical Equipment). We can assist you with all your questions about ISO regulations for medical devices.
Also learn all about our authorized representative for medical devices.
Full-service MDR compliance
Leave it to us.
MDR compliance & certification
Thus, to be in compliance with the Medical Devices 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. You can learn more about the CE medical abbreviation here. 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.
Medical devices regulation guidance from start to finish with Certification Experts
In addition to our Medical Devices Regulation (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
Are we the partner for the EU Medical Device Regulation you have been looking for?
Full-service MDR compliance
Leave it to us.
All the answers you might need!
The time required to obtain a CE mark for medical devices varies based on factors such as device classification, chosen conformity assessment route, preparation of documentation, Notified Body involvement, regulatory changes, manufacturer’s experience, timeliness of communication, availabilty, et cetera.
Generally, the process can takes up to a year, ranging from several months for Class I devices to over a year for devices requiring Notified Body assessment. Manufacturers should initiate the process well in advance to account for potential delays and ensure a smooth certification process.
If your product falls within the scope of the Medical Devices Regulations, CE marking is mandatory. With the Regulations, the rules have been tightened, and as a result, you must provide more evidence for the compliance.
If the product does not fall within the scope of the Medical Device Regulations, you will have to check if there are any other relevant Directives or Regulations. Other legislation may lead to CE marking as well; if not, it is even prohibited to apply the CE marking to your product.
In the context of the Medical Devices Regulations, the certification of your ISO 13485 quality system is not a mandatory element. While the Regulations do not explicitly mention ISO 13485, it does mandate the implementation of a Quality Management System. The EU has outlined a set of harmonised standards to guide companies in complying with the applicable requirements for medical devices in the EU. Notably, ISO 13485:2016 is the sole quality management standard listed, making it kind of mandatory for all medical devices.
Classifying your product is essential for defining the conformity assessment procedure. Medical device classes refer to mapping of medical devices based on their level of risk and the regulatory controls necessary to ensure their safety and effectiveness. In the European Union, medical devices are classified into Class I (Is, Im, Ir), Class IIa, Class IIb and Class III, based on the risk associated with their use. The classification is typically based on factors like body contact, invasiveness, administrating substances or energy, diagnostic capabilities, powered by an energy source, medicinal ingredients etc. Manufacturers must adhere to specific regulatory requirements based on the assigned risk class to ensure patient safety and device effectiveness.
Class I
- Defintion: Medical devices with low risk
- Examples: glasses, sports tape
Class Is
- Definition: Sterile medical devices with low risk
- Examples: sterile disposable syringes
Class Im
- Definition: Medical devices with a measurement function
- Examples: digital thermometers, droppers, non-invasive blood pressure monitors
Class Ir
- Definition: Reusable surgical devices
- Examples: non-invasive instruments like clamps, clips, drills, scissors, saws
Class IIa
- Definition: Medical devices with medium risk
- Examples: trainers for pelvic floor muscles, most Medical Device Software (MDSW)
Class IIb
- Definition: Medical devices with medium to high risk
- Examples: blood bags, urethral stents, dental implants, penile implants
Class III
- Definition: Medical devices with high risk
- Examples: prosthetic heart valves, cardiovascular sutures, breast implants, breast tissue expanders, devices containing supportive medicinal ingedients
A Notified Body is an organisation that is designated by a Competent Authority to assess the conformity of higher risk class medical devices, before being placed on the Union Market. Notified Bodies play a vital role in the regulatory processes for various products, including medical devices, as well as other sectors such as machinery, personal protective equipment, and more. These bodies carry out tasks that are related to conformity assessment procedures set out in the applicable legislation.
Notified Bodies operate independently and are designated by EU member states’ Competent Authorities. The European Commission maintains a comprehensive list of Notified Bodies, and each Notified Body is assigned a unique identification number. The designation process involves demonstrating the competence and impartiality of the organization.
It’s important to note that the involvement of Notified Bodies is specific to certain regulatory frameworks, such as the Medical Devices Regulations in the EU. The specific requirements and procedures can vary based on the type of product and the applicable regulations.
A Risk Management System for medical devices is a structured and systematic approach to identify, assess, control, and monitor risks associated with the entire lifecycle of medical devices. Guided by standards like ISO 14971, it involves the systematic identification of potential hazards, evaluation of risks, implementation of control measures, clear communication about residual risks, ongoing monitoring, comprehensive documentation, and integration with the Quality Management System of the manufacturer. The objective is to proactively manage risks to ensure the safety and performance of medical devices, meeting regulatory requirements and addressing potential concerns throughout the product lifecycle.
The EU MDR and IVDR are Regulations that are mandated by the European Parliament, that dictate what needs to be done by an organisation before putting a medical device on the Union Market.
ISO 13485 is an internationally recognised standard for the implementation of a Quality Management System for medical device companies around the world. Using ISO 13485 as a standard will enable any organisation to illustrate that their products meet customer and regulatory requirements.
The EU MDR and IVDR are Regulations that are mandated by the European Parliament, that dictate what needs to be done by an organisation before putting a medical device on the Union Market.
ISO 13485 is an internationally recognised standard for the implementation of a Quality Management System for medical device companies around the world. Using ISO 13485 as a standard will enable any organisation to illustrate that their products meet customer and regulatory requirements.
Our Success Stories
New Compliance
Carolina Koster Operations Manager
Van Heek Medical
Wilma Peereboom Quality Coordinator
Alfa Wassermann
Kurt Spiegel Vice President of Engineering
