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ready to access any global market
From expert consulting to full-service solutions, our specialist medical team can handle all your compliance requirements
Certification Experts has over 25 years’ experience handling classification and certification of medical devices according to the MDD and Medical Devices Regulation 2017/745 (MDR).
Obtaining CE Mark certification can be a complex and lengthy process. As your full-service compliance partner we can take this burden off your team, freeing up more of your time
Alongside our start-to-finish compliance service for medical devices, we also offer expert consulting and advice on classification and other regulatory issues.
An all-in-one compliance partner you can rely on
Together with notified bodies we handle the entire compliance process for you, freeing up your time so you can focus your expertise where it really matters
Get specialist MDR compliance advice
Unsure if your product classifies as a medical device or if you need a quality management system like ISO 13485? Our specialists can advise you on a range of medical compliance issues
Comply with all legal regulations in your markets
Our dedicated team handles gap analysis with the MDD-MDR, performs clinical trials and reviews according to all relevant EN/ISO standards, and assists with legal registration
A simpler path to your EU declaration of conformity
Compiling the right paperwork can be daunting and time-consuming for producers of medical devices. Our experts help assemble and verify your technical file so all paperwork, labelling and manuals are correct
Authorised Representation
If you’re based outside the EU orUK and want to sell your medical devices there, we can act as your AR (Authorised Representative), verifying your technical documents & products and allowing you to enter these markets
INSIGHT
Whether you’re looking for expert consulting on a compliance issue or need a full-service certification partner, we’ve got you covered.
the legal framework for your medical devices
the route to compliance
the conformity assessment procedure
can be affixed and the certificate signed
your product worry-free to the desired market
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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.
