Medical Device Registration
Registration according to the Medical Device Regulation (MDR) 2017/745
Certification Experts can act as your EC Rep to confirm your registration in EUDAMED or guide you through the medical device registration process. As your CH Rep and/or UKRP, we can register your medical devices with Swissmedic and/or MHRA.
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Medical Device Registration: Seamless Regulatory Expertise
Knowing which database to register which product in, including how it works, can be challenging for medical device economic operators (manufacturers, importers or medical Authorised Representatives/Authorised Representative: UKRP or EC REP). However, our team of experts can support you with the registration of medical devices in Europe, the UK and China and makes this process easier for you.
EUDAMED medical device registration Europe
Registration of medical devices is mandatory under the Medical Device Regulation 2017/745. Chapter 3 of the regulation – Articles 22 to 30 – is entirely devoted to identifying, tracking and registering economic operators and their products, and specifies the databases designed for this purpose. EU medical device registration Europe occurs through the EU medical device registration database EUDAMED. As a manufacturer you will have to register yourself, and, if required, simultaneously provide the information of your European Authorised Representative (EC Rep), and your (In Vitro Diagnostic) Medical Devices.
Certification Experts can support with the EUDAMED registration and/or Certification Experts can act as your designated Authorised Representative. In this case we will be notified by EUDAMED and verify the application.
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Getting an Single Registration Number (SRN)
A Single Registration Number (SRN) is an unique identifier allocated to your organisation by a European Competent Authority. SRN’s are exclusively provided to entities, often referred to as ‘Economic Operators,’ necessitating medical device registration in Europe within EUDAMED, the European Database for Medical Devices. Applying for an SRN can be an overwhelming process that also includes completing registration in EUDAMED.
After the application of the registration of your company, Competent Authorities will verify application. Once the application is approved; your company will receive an Actor ID/Single Registration Number (SRN).
Registration of different Classes medical devices
The European Medical Device Regulation (MDR) classifies medical devices into different classes based on their potential risk to patients and users. The MDR distinguishes between four main classes, you can find the explanation of the different classes here. In accordance with the MDR, medical device registration Europe obligations within EUDAMED can vary depending on the classification of the medical device. Here is a general summary of how different MDR classifications can influence the registration procedure:
- Class I: Manufacturers of Class I medical devices are obliged to register their devices in EUDAMED, without the need for involvement from a Notified Body for conformity assessment. The registration process for Class I devices is typically straightforward.
- Class Is (sterile), Im (measuring), Ir (reusable), IIa, IIb, and III: Manufacturers of these classes medical devices are also required to register their products in EUDAMED. However, the engagement of a Notified Body is mandated to assess conformity. The registration process for these classes may involve more (rigorous) evaluation due to the heightened risk associated with these devices.
Additionally, it is important to note that before being able to enter the European Market, you must set up a UDI (Unique Device Identifier) system. After this is completed, you must enter the UDI-DI of your products, as stated in the MDR 2017/745, in EUDAMED.
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Registration of Medical Devices in Switzerland with Swissmedic
In addition to EU registration, obtaining separate registration in Switzerland is crucial due to the country’s distinct regulatory framework. While Switzerland is not a member of the European Union, it has its own stringent requirements for medical device approval. Swissmedic, the regulatory authority in Switzerland, evaluates medical devices based on specific safety, efficacy, and quality standards that may differ from those in the EU.
This means that even if your product is registered in the EU, it must still undergo a separate assessment by Swissmedic to ensure compliance with Swiss regulations. Failing to secure this registration could prevent your medical devices from being marketed in Switzerland, limiting your access to this important market. Therefore, a comprehensive approach to regulatory compliance requires addressing both EU and Swiss registration processes to maximize your product’s reach and success.
Certification Experts provides essential support for the registration of medical devices in Switzerland, including:
- Acting as your CH Rep
- Guide you through all applications,
- Set up and implement appropriate and required systems
- Support Swissmedic registration of medical devices
MHRA medical device registration in the UK
Due to Brexit, manufacturers and importers of medical devices shall perform the registration of medical devices within the Medicines and Healthcare products Regulatory Agency (MHRA). Medical Devices traded within the UK must be in compliance with either the UK MDR 2002 or the EU CE marking. The UK Government has decided to extend the recognition of the CE marking for an extended period of time. This means Medical Devices compliant with:
- Legacy devices MDD can be registered until 30 June 2027/2028;
- IVDD A, B, or C; EU IVDR and EU MDR can be registered until 30 June 2030.
In regard to the legacy devices in compliance with MDD, you will have to provide an EU MDR Article 120 extension confirmation letter as well. Higher risk devices (class III and IIb implantable devices) can be brought to the UK market until 2027. For medium and lower risk devices (class IIb general, class IIa, class Im, Is and Ir devices) can be brought to the UK market until 2028.
For manufacturers based outside of the UK who want to sell their products within the UK, it is mandatory by the MHRA to appoint a UKRP. This will ensure that your products are registered in the correct system. However, to be able to do so, you must first create an account on the MHRA DORS.
The registration process for MHRA Class I medical device registration is similar to the MHRA registration of medical devices of Class IIa, IIb, and III medical devices, eventhough Class I Medical Devices already need to be MDR compliant.
In short, medical device product registration in the UK is no less complex. In this market too, Certification Experts can:
- Act as your UKRP
- Guide you through all applications,
- Set up and implement appropriate and required systems
- Support MHRA registration of medical devices
NMPA registration in China
NMPA (National Medical Products Administration) registration is obligatory for medical devices intended for sale, distribution, or use within China. This regulatory authority in China is responsible for enforcing stringent standards to guarantee the safety, quality, and effectiveness of medical devices in the Chinese market.
The specific prerequisites and procedures for registration can vary, contingent on the classification of the medical device and its intended purpose. Less complex registration processes may apply to lower-risk devices, whereas higher-risk devices often necessitate more rigorous assessments, including clinical trials and engagement with a local Chinese representative.
For manufacturers and distributors of medical devices, compliance with China’s regulatory mandates, including NMPA registration, is imperative to legally introduce and distribute medical devices within the Chinese market. Non-compliance can result in access challenges and legal repercussions.
Certification Experts: Medical Device Registration
All medical devices need to be registered to be sold in Europe, the UK and/or China. If your medical device is not registered or not registered correctly, you will not have legal permission to market your product in the desired market – there are even fines for this if you do not meet the legal requirements. To avoid this, it is highly recommended to appoint an expert to support you with these processes and registrations. Certification Experts offers diffent support:
- Classify your product
- Offer full compliance support
- Obtain the correct marking for your product
- Guide the registration process
- Register as your EC REP/UKRP/NMPA agent
- Support with the UDI and registation of your products in EUDAMED or with the MHRA and the NMPA.
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All the answers you might need!
In the EU, appoint a European Authorised Representative (EC-REP) if based outside EU, conduct a conformity assessment (involving a notified body for higher-risk devices), and implement a Quality Management System (ISO 13485) and register the device in EUDAMED to obtain a Single Registration Number (SRN).
In Switzerland, appoint a Swiss Authorized Representative (CH-REP) if based outside Switzerland, conduct a conformity assessment, compile a Technical File and register the device with Swissmedic.
In the UK, appoint a UK Responsible Person (UKRP) if based outside the UK, conduct a conformity assessment (involving a Approved Body for higher-risk devices) and register the device with the MHRA.
Ensure to maintain comprehensive documentation and comply with post-market surveillance requirements.
There are no risks associated with registering your medical devices, however, there are risks associated with not registering your product. If you do not register your device, it cannot be legally traded on the European/UK/CH market. There are penalties for this.
Medical device registration is a mandatory process that requires you to register both the economic operators within the supply chain of a medical device, and the medical device with authorities and databases before you are allowed to market your product in the associated market. For example, there is a difference between NAFDAC registration medical devices (Nigeria), moh medical device registration (Vietnam) and medical device registration European Union.
Registering a medical device is obligatory due to product legislation, ensuring patient safety, regulatory compliance, and quality assurance. It verifies that devices meet strict standards and perform as intended, providing legal authorisation to sell and distribute them in specific markets such as the EU, UK, and Switzerland. Registration facilitates traceability, allowing effective management of recalls and adverse event reporting, and offers transparency about the device’s efficacy and safety. It also ensures ongoing post-market surveillance to monitor performance and address potential issues. Overall, registration enhances the manufacturer’s credibility by demonstrating a commitment to high safety and quality standards. Please note that you will receive a notification of the registration, but not a medical device registration certificate.
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