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Services according to the Medical Device Regulation (MDR) 2017/745
Certification Experts can be your full-service compliance partner and guide you through the complete CE marking process for medical devices. With over 25 years of experience, our team of 15+ specialists will help you to obtain access to the EU/UK market.
The CE mark for medical devices is by definition the mark that indicates that your medical device is in compliance with the European product legislation. It is mandatory for all manufactures whose products fall within the Medical Device Regulation 2017/745, to get CE certification for their medical devices before they can access the European market.
Obtaining CE approval for medical devices can be a complex and lengthy process. This is because it requires for you to implement both a conformity assessment procedure according to the MDR, wich requires you to consider the GSPR, Risk Management, EUDAMED, UDI, PMS, clinical evidence etc., and a Quality Management System (ISO 13485).
Our experts can guide you through all processes and help you implement all necessary procedures as required by Medical Device Regulation 2017/745. As your full-service compliance partner, we can take the burden of getting CE medical device certification off your team.
Guidance under the new regulations: from MDD to MDR
What was previously known as the Medical Device Directive (MDD) 93/42/EEC has been replaced by Medical Device Regulation 2017/745 (MDR). This means that existing medical devices that have been CE marked under the MDD need to be recertified under the new regulation. The following has changed:
How can I start the CE marking process for medical devices?
For medical devices, CE marking is mandatory, but before you can get your device marked, it is necessary to determine whether your product falls within Medical Device Regulation 2017/745. Based on the intended use and the medical claims, it needs to be determined whether the classification rules are applicable to the device. If the product is defined as a medical device, it will be classified, which then determines what conformity assessment procedure needs to be followed. To then start the procedure of obtaining CE marking for medical devices, you need to compile a technical file, apply with a Notified Body (NoBo) and implement a Quality Management System (QMS).
What classes are there?
Classifying your product is an essential part of the CE certification for medical devices. Because of the transition from MDD to MDR, it is possible that your product currently falls within a different class than it might have previously. The following table provides an overview of all classes.
|
Classification of devices |
Definition |
Examples |
|
Class I |
Low risk medical devices |
Spectacles, sports tape |
|
Class Is |
Sterile low risk medical devices |
Sterile single-use syringes |
|
Class Im |
Low risk medical devices for measuring |
Clinical thermometers, droppers, non-evasive blood pressure measuring device |
|
Class Ir |
Reusable low risk non-invasive surgical medical devices |
Non invasive devices such as clamps, clips, drills, scissors, saws |
|
Class IIa |
Medium risk medical devices |
Pelvic floor muscle trainers, most Medical Device Software (MDSW) |
|
Class IIb |
Medium to high risk medical devices |
Blood bags, urethral stents, dental implants, penile implants |
|
Class III |
High risk medical devices |
Invasive devices such as prosthetic heart valves, cardiovascular sutures, breast implants, breast tissue expanders, custom made devices. |
Certification Experts can help you to determine the class of your device.
Procedure CE mark medical devices
When you want to bring a medical device onto the market, you need to implement both a conformity assessment procedure and a QMS (ISO 13485); take into account the CE mark labelling requirements for medical devices; and consider the GSPR, EUDAMED, UDI, PMS, clinical trial etc. If you are located outside of the EU, and you want to bring your device onto the European market, you need an Authorised Representative (EC REP) to act as a liaison between you and the competent national authorities. Because the MDD has been replaces by the MDR, obtaining CE marking for your medical device can be quite a prolonged and demanding process. Our team of experts has the know-how to manage this process for you.
International product marking: FDA and UKCA
Food and Drugs Administration (FDA) is a federal agency for medical devices within the USA. Part of their responsibility is the regulation of market access of medical devices and monitors the safety requirements of all medical products. The MDR is more in line with the FDA than the MDD was.Certification Experts can perform a GAP analysis of FDA approved documentation, which is part of the technical documentation necessary for the CE marking process.
Because of Brexit, medical devices that are currently being sold on the UK market need to be UKCA marked, instead of CE marked. Our experts can help you obtain UKCA marking for all class I medical devices. We can additionally act as your UK Responsible Person (UKRP) and register your device with the MHRA.
INSIGHT
Click on the service blocks bellow to see what our experts can do to help you obtain the CE mark for your medical devices.
the legal framework for your medical device
the technical file
the conformity assessment procedure (with a NoBo) & a QMS
the medical device in EUDAMED, Notis or/and MHRA
your Post Market Surveillance System
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CE Medical can check if your device falls within the scope of the MDR. Under the MDD and MDR devices are divided into four classes: I, IIa, IIb and III. Devices are ranked according to their risk: starting from class I for the lowest-risk devices to class III for the highest. We can classify the device based on its intended use. Due to the transition of the MDD to MDR, a medical device can fall within a higher class. Our experts can determine whether this impacts the classification of your device. The classification decides the further conformity assessment route.
CE Medical will help you enter the European Market with your medical device. We offer complete certification guidance and expert services in order to ensure your medical device is compliant with the CE marking legislation. Additionally, we can ensure that your organisation has a Quality Management System (QMS) in place.
CE Medical can set up, implement, review and maintain a Quality Management System (QMS) for your organisation. We provide an appropriate QMS based on your situation and wishes.
Every manufacturer requires a technical file to be able to demonstrate the device’s compliance. CE Medical can prepare technical documentation, along with providing support, compiling and reviewing the required technical documentation for you.
CE Medical can provide pre-compliance testing and guide your company with the appropriate testing.
A clinical evaluation is required for medical devices of all risk classes. A Clinical Evaluation Report (CER) documents the conclusions to verify the safety, clinical performance and/or effectiveness of the medical device when used according to the manufacturer’s intended use. CE Medical can guide your company with the CER (plan, analysis and report).
For manufacturers of medical devices who are based outside of the EU/UK, appointing an Authorised Representative (EC REP) in Europe or a UK Responsible Person (UKRP) in the UK is mandatory. An EC REP/UKRP is a legal party based within the European Union/UK that acts as a liaison between a manufacturer outside of the EU/UK and competent national authorities within the EU/UK. CE Medical can act as an EC REP/UKRP on behalf of your organisation to ensure that the devices being sold on the EU/UK market comply with the product compliance legislations. This concerns devices that are sold either directly, via e-commerce (online), or through a fulfilment service provider. The EC REP/UKRP will register the medical devices with the competent authorities.
Medical devices should conform to the requirements stated in the applicable regulations. For higher risk medical devices, the technical documentation must be reviewed by a Notified Body (NoBo). CE Medical can guide this process, and submit the documentation to the Notified Body and ensure that the file is complete for the certification.
CE Medical can assist with registering in EUDAMED and with UDI. EUDAMED is a European database for medical devices. Regulation (EU) 2017/745 on medical devices and regulation (EU) 2017/746 on vitro diagnostic medical devices introduce an EU device identification system. It is based on a unique device identifier (UDI) and allows for easier traceability of medical devices. This requires that manufacturers submit in EUDAMED the UDI/Device information of all devices they place on the EU market. Importers, authorised representatives and system/procedure packers must also register in EUDAMED.
CE Medical offers training programs for CE marking and Quality Management Systems (QMS). This provides you with the knowledge on how to enter your medical device safely onto the EU Market.
We notify you if there are regulatory changes pertaining to your product
We help you eliminate risks more efficiently, protect your customers and your business. Unsure whether you’ve done something correctly? We can provide a full risk assessment evaluation.
We provide Authorised Representation (AR) for businesses and e-commerce companies located outside the EU/UK – allowing access to those markets by registering us as your legal partner.
Every manufacturer requires a technical file to reach compliance. We support, compile and review these technical documents for you.
We review your designs and assist you through the prototype phase to ensure critical safety standards are met.
Wherever you’re located, we offer a wide range of expert testing and inspection capabilities, both in house and via our global network of affiliated partners and testing laboratories.
We create a clear and practical compliance roadmap for you in any market. Get expert guidance on cost/time efficiency of certification for accessing multiple markets.
We offer custom training programs led by experts, bringing your team up to
speed with important safety processes and regulations related to your markets.
Make sure your manuals, labelling and packaging are fully compliant with your
chosen markets. From writing to reviewing materials, we’ve got you covered.
We ensure the availability of the technical file in case of requests from authorities
With over 25 years’ industry experience, our team can provide expert guidance
on every aspect of product compliance.
Trust us as your partner to verify the compliance of your products
We register as your official point of contact for market surveillance authorities
You gain access to the EU/UK market, no matter where your business is located
We represent you on your behalf for all legal issues pertaining to your product
Enter any market, no matter the marking or industry. From CE marking and UL to CCC, we offer complete certification guidance and expert services tailored to your unique situation.
