Medical devices are delicate products that need careful planning before you start selling. If you’re going to start such a business in Europe, you must know that there are rules and regulations to follow. You must comply with Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) laws.
So, if you’re wondering how to sell medical devices in Europe, you must familiarize yourself with the laws of the land. Here is a step-by-step process you need to start selling medical devices in Europe.
1. Understand European Regulatory + Determine your Device Classification
Before you launch your products, you must be careful not to get in trouble with the authorities for not complying with the regulations.
The first step is to ascertain whether the device you intend to sell is indeed a medical device. Some devices are classified as retail products, food supplements, etc., requiring a different form of regulation from medical devices.
A medical device must meet the classification by either the European Union Medical Device Regulations (EU MDR) or the In Vitro Diagnostic Medical Device (IVD). Any device within the two classifications should contain the Conformité Européenne (CE) mark, which indicates that it meets the EC Medical Device Directives.
Once you already have the EUMDR, you must also understand that European countries have different directives when it comes to selling medical devices.
However, you must comply with European law before narrowing it down to national law. The most important European laws for selling medical devices include the 2017/745 MDR and the 2017/746 IVDR regulations. European and national laws are important for the manufacturers of medical devices and must be followed strictly.
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2. Appoint an Authorized Representative
If you’re not located in the European Single Market, you must appoint an EU Authorised Representative (AR). The MDR and IVDR regulations require that the representative share liability with the medical device manufacturer on the market.
An EU AR is an important figure in this business. First, they must appear on the product label as well as the Declaration of Conformity. Secondly, they must be ready to be the local contact for EU national Competent Authorities.
For the medical device to get a CE Marking, you must first appoint the EU AR. You will need to prove to the Notified Body that you have appointed an EU AR during their assessment. If you fail to do this, you will not get authorization to sell medical devices in Europe.
3. Obtain CE Marking
Your medical device needs a Conformité Européenne (CE) mark that confirms that the device adheres to EC Medical Device Directives. The CE accreditation gives the device the freedom to sell in any European market.
Getting a CE marking is another process that must comply with the MDR/IVDR requirements in generating the following:
- Technical documentation file (TDF): The medical device manufacturer must provide technical documentation for the medical device. You will need the TDF for the medical equipment authorization and conformity assessment.
- Quality management system (QMS): You also need a quality management system to be certified by the Notified Body before selling your medical device in Europe.
Notified bodies are tasked with evaluating the device to ensure it meets the minimum safety and efficiency requirements. Once the bodies give your product a green light, they will issue a CE Marking certificate that authorizes it to enter the European market.
Remember, the thorough evaluation by the Notified Body only applies to products considered high-risk. It can take up to 12 months to complete the review and insurance of CE marking, mostly dependent on the number of pending applications. The product will undergo clinical and non-clinical evidence for approval during the review process.
For low-risk products, the manufacturer themselves can certify compliance and issue a CE marking. They will get TDF and QMS and certify that the product meets the minimum MDR/IVDR requirements. The process will not involve any external bodies.
4. Find a Distributor
Once you comply with the regulations and get the green light to begin selling medical devices in Europe, the next step is to sign up a distributor. A distributor will be legally responsible for ensuring the product gets to the market up to the point of being used as a service. A distributor will act as your business partner; hence, they must be reliable.
Before agreeing to distribute the product on behalf of the manufacturer, the distributor must ensure the device meets and complies with the MDR/IVDR regulations. They must ensure the device has CE Marking and an EU Declaration of Conformity. They should also confirm that the labels and instructions for the use of the product are properly written in the official languages of the country it intends to sell to.
Once the distributor confirms that the device complies with all the regulations, they will provide appropriate storage and distribution. These should be in line with the manufacturer's recommendations.
The distributors should not store, transport, or distribute any medical device that does not comply with the regulations. For non-compliant devices, the distributors must immediately report to the authorities for further action.
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5. Comply with Marketing Laws
At this stage, your medical device will have overcome many obstacles and be ready to launch. So, the next step you will need to take is marketing your medical device. But before you start marketing, ensure you comply with the European marketing laws for medical devices.
The regulatory guidelines to consider include those that protect consumer privacy rights and those governing the advertising and promotion of medicines and medical devices. To retain your CE Mark, you must ensure that your digital marketing complies with the EU MDR laws.
One crucial factor to consider when advertising is the device’s intended use. This is the purpose for which the device is intended, according to the manufacturer. It should also contain the instructions for use.
The intended purpose of the device also acts as a guide for what you can and cannot say during sales and marketing. You shall not use any names, text, images, trademarks, or figuratives that could potentially mislead the user regarding the device’s intended purpose.
Different Countries have Different Marketing Laws
Depending on the country, you will have different regulations on marketing (i.e., TV ads, newspaper ads) and selling strategies (i.e., visiting doctors, etc.). The EU MDR doesn’t have specific laws and regulations regarding sales and promotion of the devices. You should check your specific country’s regulations and demographics for marketing.
The EU MDR rules and regulations will not supersede individual countries’ laws on the marketing and promotion of the device. You must comply with the EU MDR regulations as well as follow individual country’s laws of marketing and promotion of a medical device.
Ready to Enter the European Market?
Selling medical devices in Europe is not hard as long as you comply with all the EU MDR and IVDR laws. You must follow all the steps, from identifying your product, understanding the legal regulations, getting the EC marking, and finding a reliable distributor to the marketing of the device.
If you feel stuck at any of the above stages, Masson International is here to help you enter the European market. We understand the struggles businesses that want to sell medical devices go through, and we’re here to make everything easy. We provide tailor-made solutions to help you start selling medical devices in Europe with ease. Visit our website for more information about the services we provide.