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Cracking the Code: A Comprehensive Guide to Achieving Medical Device Approval in the EU

By: Janice Farris

Do you want to market and sell your medical device in the EU? Well, let us take a detailed dive into the ins and outs of getting approval; do not worry, anyone is capable of tackling this beast. While I’m sure that you have heard the horror stories of EU MDR (European Union Medical Device Regulation 2017/745), I’m here to tell you that it’s not something that should send you running and screaming! Like any regulatory beast, just adhere to the requirements and you’ll get approval in due time. 

The first step in tackling the beast is hunting it down. In EU MDR talk, you first need to classify your device. Like the FDA, the MDR has risk classes I to III increasing from a device that poses minimal risk to patient safety to a device that provides life sustaining care. The EU MDR 2017/745 has 22 rules to use in order to properly classify your device that you can find in Article 51. 

Once you identify the nature of the beast, or the classification of your device, you can begin preparing for the battle. Europe requires medical device companies to have a QMS (Quality Management System) and technical documentation. A Quality Management System is a comprehensive, formalized system that documents processes, procedures, and responsibilities that the company follows to achieve quality policies and deliver consistently high-quality products. If your device is not Class I, your QMS will need to be ISO 13485 certified by a notified body. Like the FDA, the EU MDR requires medical device companies to have SOPs (Standard Operating Procedures), work instructions, supplier management, validated systems, internal audits, etc within their QMS. 

Technical documentation is an EU MDR specific requirement and is a prerequisite for the conformity assessment. Specific requirements of the technical file can be found in Annex II of the MDR. These requirements include, but are not limited to, a UDI (Unique Device Identifier), intended use, labeling (package label, instructions for use, etc.), manufacturing information, verification and validation procedures and reports, risk management file, and post market surveillance.  The idea of the technical file is similar to the FDA’s Design History File, but the technical file must be presented as a single PDF document. 

The technical file must include a Clinical Evaluation Report (CER) that contains

clinical data related to the safety, performance, and usability of the

medical device. The purpose of this document is to prove that the device will

perform as it is intended to and is safe for users. The CER is a living document,

as pre-clinical, pre-market and post-market data should all be included and

analyzed. MDR requires a thorough analysis of current state-of-the-art,

or treatments that are currently and generally accepted as good practice.

This is essentially an extensive evaluation of alternative treatment methods or benchmark devices for the indications that your device claims. An in depth, detailed, and justified literature review can be performed to find all relevant data (favorable and unfavorable); EU MDR enacts strict obligations regarding literature reviews. Additionally, the CER must identify and discuss risks related to the device and provide an acceptable benefit-risk profile.

A clinical evaluation of equivalence may be conducted for the CER, in which the clinical data is pulled from a device that has such similar technical, biological, and clinical characteristics that there is no clinically significant difference in the safety or performance of the two devices. MDR has tightened the equivalence justification requirements; for example, for Class III and implantable devices to claim equivalence, the manufacturers of the two devices must have a contract that allows full access to technical documentation on a continuous basis. 

EU MDR introduces a new requirement for the designation of a person responsible for regulatory compliance (PRRC) if the medical device manufacturer has more than 50 employees and 10 million Euros in global sales revenue. The qualifications and responsibilities for the PRRC are laid out in Article 15 of EU MDR 2017/745. The PRRC must have four years of professional experience within medical device regulatory affairs or quality management system roles or have a university degree in law, pharmacy, medicine, engineering, or a relevant scientific discipline and one year of the professional experience described prior. The PRRC is responsible for ensuring that the technical documentation, EU declaration of conformity, and quality management system is robust and current and post-market surveillance and reporting obligations are satisfied.

When faced with the beast of regulation, the best resource is someone who has faced the same challenges that you are approaching. An EU Authorized Representative will provide that knowledge and guidance in your pathway to EU market clearance. An EU Authorized Representative is a legal entity located in the EU that represents and aids non-EU manufacturers in complying to EU regulations. The Authorized Representative acts as a liaison between manufacturers and EU National Authorities. The responsibilities of authorized representatives are listed in Article 11 of the EU MDR 2017/745 and include verification of technical files and EU declaration of conformities, registration of medical devices with the appropriate National Authorities, and notification of complaints from users or healthcare professionals to the manufacturer and Competent Authorities. Personally, I have used Obelis Group to gain EU market approval and they made the process very clear and straightforward for an EU newbie like me. They were extremely responsive and always willing to answer any questions I had. In my opinion, the Authorized Representative is the reason why it seems like the EU has a clearer and easier pathway to market for medical devices than the US. Authorized Representatives pride themselves on consistently offering a hand to those working toward marketing their product. 

Touching on the EU Declaration of Conformity (DoC), this is the document where the manufacturer accepts all responsibility for compliance of the device. It must declare that the product fulfills the necessary requirements of the CE marking directives and EU regulations and contain the contact details of the manufacturer and authorized representative. Devices can be covered under multiple CE marking directives and each has their own requirements for the DoC, so be sure to check out which one(s) your device falls under!

The final obstacle in tackling your beast is achieving approval from a Notified Body. Under EU MDR, you are required to choose a notified body (which is an independent organization that has been accredited by an EU Member State) to assess and approve the conformity, safety, and efficacy of your product. As the FDA is to the United States, Notified Bodies are to the EU. They are the ones who issue CE certificates, which is the golden ticket that you need to market your medical device in the EU. A list of Notified Bodies that are authorized for CE mark certification can be found on the NANDO (New Approach Notified and Designated Organization) website. Class I medical devices that are non-sterile, do not have a measuring function, and are not reusable surgical instruments are exempted from going through a Notified Body.

Along with EU MDR 2017/745 came an update to EUDAMED. This is the official database where data is stored on all medical devices registered in the EU. This database will be publicly accessible in order to encourage transparency, high performance, and safety of products. EUDAMED has six modules: actor registration, UDI and device registration, notified bodies and certificates, clinical and performance studies, vigilance, and market surveillance. It is necessary for all medical device companies to register manufacturers and devices on EUDAMED. 

After your medical device has been approved by a notified body and you are selling in the EU, the regulatory battle is still not over. Similar to the FDA requirements, the MDR necessitates that medical device companies conduct post-market surveillance on their devices. This entails keeping tabs on the devices once they are in the user’s hands and conducting trend analysis. Medical device companies should use information and experience gathered from their devices on the market to establish corrective and preventative actions (CAPAs) that improve their processes and eliminate causes of non-conformities. 

With your medical device on the market and constantly being used by customers, you must practice vigilance. In the case of our beast, vigilance is spreading awareness if it is ever uncontrollable or poses a threat to society. Similarly, the EU MDR defines vigilance as “the identification, reporting and trending of serious incidents and the conduct of safety related corrective actions.” Every “serious incident” or corrective action related to the safety of the device must be officially reported to the EUDAMED database. The EU MDR demands a 2-day reporting deadline for serious public health threats, a 10-day reporting deadline for a death or serious health deterioration, and a 15-day reporting deadline for all other serious incidents. Because of these reporting deadlines, the EU MDR encourages the safety and efficacy of products and allows medical device companies to build trusting and transparent relationships with patients. 

The European Medical Device Regulations are designed to improve the safety, performance, and quality of medical devices. A high level of clinical evidence, post-market surveillance, technical documentation, and quality management is required in order to market a medical device in the EU, but just remember that the ultimate goal is to ensure patient safety! The process to market might seem long and tedious, but the EU MDR does a good job of clearly defining requirements and paving the path for a successful medical device company. With patience and diligence, you can tackle the beast and get your medical device approved for market in the EU!

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