Medical Device Certification - CE Marking & FDA

Product Certification for MedTech Companies

Medical device certification is complex and expensive. Medical products of higher risk class must undergo a series of rigorous tests before they are released for sale.

MedTech companies must comply with strict product safety regulations and pay extra attention to various regulatory and compliance standards. As a result, they often feel lost in the regulatory maze and turn to us for help!

ce marking medical devices
fda certification service for medical manufacturers

Main issues for MedTech companies

Medical device manufacturers must face several challenges before they can place their products on the market of their choice.

  • Complex regulatory framework
  • Quality control issues
  • Surprisingly high costs
  • Access to designated Notified Bodies
  • Extremely long certification process

Our way to help with medical device certification

We help MedTech companies overcome the complexity of the regulatory framework and understand the product safety requirements as best as they can. Our digital approach to CE marking medical devices helps companies cut their costs and time to market drastically. For instance, manufacturers of class I devices can get their products on the market in less than two months.

Our approach to medical device certification includes the following elements:

CE expert guidance

We will assign you one of our CE experts, and they will guide throughout the entire CE marking certification process of your medical device. The expert will start the process by reviewing your existing product development documentation, classifying your product and performing a GAP analysis.

medical device certification services

Digital Workshops

Our service for CE marking self-certification of medical devices is based on expert guidance via web workshops and templates. Once the GAP analysis is finalised, our expert will prepare an action plan, considering your web workshops' availability. The action plan includes the date, time and agenda of each web workshop. You can have as many workshops as you need to complete the CE marking certification process. Each workshop lasts about 1 - 1.5h.

Complete Set of Templates

Once the action plan is ready, we'll provide you with all the templates needed for your medical device CE marking certification under the MDD, MDR, IVDD or IVDR. The expert will then show you how to fill them out via web workshops and review the work as you go along to ensure everything is done correctly. At the end of the process, you will receive a Declaration of Conformity.

The templates include documents, such as risk assessment file, hazards report, quality management system, classification report, verification report, Declaration of Conformity, and more

Testing & Notified body assistance

Some class I medical devices and products of class II and III, need to pass accredited testing and/or receive approval from an EU Notified Body. We will try to provide the necessary assistance if requested.

We partner with several accredited test labs and Notified Bodies that can provide conformity services for both medical hardware devices and medical software devices.

Frequently Asked Questions

What is a medical device according to the MDR?
According to Chapter 1, Article 2 of the MDR 2017/745, a medical device is any product used for human beings for one or several of the following medical purposes:
  • diagnosis, monitoring, prediction, prevention, prognosis, treatment or alleviation of disease, injury or disability
  • investigation, modification and/or replacement of the anatomy or of a pathological or physiological process or state
  • providing data through in vitro examination of specimens and which does not achieve its main intended action by pharmacological, immunological or metabolic means but may be assisted in its function by such means.
Additionally, a medical device can also be:
  • an apparatus for the control or support of conception
  • a product used explicitly for the cleaning, disinfection or sterilisation of medical devices.
What is an in-vitro medical device according to the IVDR?
Referring to Chapter 1, Article 2 of the IVDR 2017/746, an in-vitro diagnostic medical device is any device intended by the producer to be used in vitro for the examination of specimens solely or primarily to provide information on one or several of the following:
  • concerning congenital physical or mental impairments
  • concerning a physiological or pathological process/state
  • to predict treatment response or reactions
  • concerning the predisposition to a health condition or a disease
  • to define or monitoring therapeutic measures
  • to establish the compatibility and safety with potential recipients
Specimen receptacles can also be in-vitro medical devices.
What products need FDA certification?
In comparison to CE marking, FDA compliance is required for a considerably wider range of goods sold on the US market:
  • Human food and dietary supplements
  • Animal food and veterinary medicines
  • Cosmetics products, such as shampoo and make-up
  • Pharmaceutical products
  • Biologic products (e.g. human plasma, blood and embryos)
  • Tobacco products, as well as e-cigarettes and other electronic nicotine delivery systems
  • Medical devices, including software products
  • Radiation-emitting products (e.g. microwave ovens and CD-ROMs)
What is a quality management system (QMS)?
A quality management system for medical devices is a formalised system that document processes, procedures, and responsibilities to ensure and continuously improve the standard of business activities.
What is a Notified body conformity assessment?
A Notified body conformity assessment is a procedure performed by a third-party conformity assessment body. It demonstrates whether the requirements relating to the medical device have been fulfilled. A list of all Notified bodies is available in the NANDO database.
How much does a Notified body assessment cost?
A Notified body assessment cost depends on product type, risk class, and applicable product safety requirements. Usually, a Notified body assessment of a class IIa product's quality management system for small companies is about €15,000. Our compliance team can help you fill out an application form for conformity assessment and submit it to a relevant Notified body.
What is EUDAMED?
EUDAMED is an IT system developed by the European Commission to implement MDR (EU) 2017/745 and IVDR (EU) 2017/746 to improve transparency and coordination of data regarding medical devices available on the EU single market. EUDAMED will be open to the public and will function as a registration, collaborative, notification and dissemination system. We at Clever Compliance can assist with the registration of medical devices to the EUDAMED.
What is the difference between MDD 93/42/EEC and MDR (EU) 2017/745?
Whereas MDD 93/42/EEC focuses on pre-approval requirements, MDR (EU) 2017/745 demands control over procedures and documents throughout a medical device's lifecycle. The Medical Device Regulation (MDR) comes with stricter requirements, affecting areas, such as clinical evidence, post-market surveillance, risk management, technical documentation and quality management system. The new Regulation also introduces classification rule 11 on the use of information obtained for decisions with diagnosis or therapeutic purposes. The MDR will become applicable and replace the MDD as of May 26th, 2021.
What are the steps in the CE marking process for medical devices?
The process for obtaining a CE marking approval for medical devices is quite complex and prolonged. Manufacturers must address several aspects before they can sell their medical devices in the EU/EEA:
  • Examine the classification rules to determine the correct risk class of the medical device
  • Perform a regulatory GAP analysis to determine all applicable requirements, obligations, technical file contents and conformity procedures.
  • Set up proper technical documentation (also known as "technical file")
  • Set up a quality management system
  • Where applicable, carry out a Notified body conformity assessment
  • Draw up an EU declaration of conformity
  • Register the medical device with the relevant market authorities.
We at Clever Compliance can help you with the entire, or parts of, the medical device certification process. Get in touch with our team to schedule a digital walk-through of what MDR/IVDR is and learn more about how we can help you.
What are the steps in the FDA certification process?
Depending on product type, the FDA certification process includes the following steps:
  • Determine the indication for use
  • Determine the proper 7-digit regulation number and classification type
  • Find a predicate device and create a comparison chart
  • Carry out required performance tests
  • Fill out an FDA 510(k) documentation set properly
  • Register the product with the FDA by submitting an application.
We at Clever Compliance can provide assistance with the entire certification process, from start to finish. Our compliance team can also help you perform Q-submission, De Novo classification and premarket approval procedures for products with no predicate devices. Get in touch with our team to schedule a digital walk-through of what FDA certification is and learn more about how we can help you.
Do I need CE marking to sell in Europe if I already have an FDA-approved product?
Yes, all medical devices sold on the EU single market must be CE compliance and registered in the European database. Unfortunately, FDA is not an accepted certification scheme in Europe. Get in touch with us to learn how we can help you meet the CE marking requirements and get answers to all of your questions.
Do I need FDA certification to sell in the USA if I already have a CE-marked product?
Yes, all products falling within the scope of the FDA legislation must be FDA certified to be sold in the United States. Unfortunately, CE marking is not an accepted certification scheme in the States. Get in touch with us to learn how we can help you meet the FDA requirements and get answers to all of your questions.
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