Finding Talent To CE Mark Medical Devices
It’s crucial to obtain a CE Mark for your medical device if you want to be able to sell your product in the European Union, so finding the right talent that can help you smoothly navigate the compliance process and avoid unnecessary delays is invaluable. Drawing from our extensive experience in placing great CE marking professionals, we can share with you some of the key attributes to look out for in hiring exemplary talent to CE mark medical devices. With the right professionals in place, you can ensure that your product launches aren’t being slowed down by a lack of compliance.
What is a CE mark for medical devices/IVDs and why is it important?
A CE mark is a legal requirement for a medical device/IVD manufacturer to claim in order to access the European market. It is a seal of approval for your product and ensures that you are compliant with the General Safety and Performance Requirements (GSPR) for the relevant EU regulations for your medical device/IVD. Obtaining a CE mark for your medical device means that you can sell your product anywhere in Europe as it is a single market. For a medical device/IVD device to be sold in the UK, it will need UKCA Certification and in addition must be registered with the MHRA before being able to access the market. There is currently an ongoing transition period lasting until the 30th of June, 2023 for existing CE certifications to be replaced with the UKCA mark. Once your device has successfully obtained a CE mark from a notified body, its validity period is 3 years.
A CE mark is not a guarantee that your product is entirely safe and of excellent quality. It just means that it meets the legally required standards of the regulations for medical devices in the European market. Therefore, it is important to focus on hiring the best CE mark medical device professionals so that your company can avoid the trap of merely trying to meet the minimum standards, and great CE marking professionals can help you avoid delays in getting your product on the market whilst ensuring that you meet the best safety and quality standards.
How to CE mark medical devices
The requirements in obtaining a CE mark and complying with the EU Medical Devices Regulation (MDR 2017/745) are stringent in order to ensure patient safety, and meeting these requirements requires navigating through various stages – there are no shortcuts to obtaining a CE mark! The first step is classifying your medical/IVD device in accordance with the MDR/IVDR regulations. This class definition is based on the perceived safety of your device, with higher-risk devices requiring a more laborious process and tighter controls in meeting safety standards for acquiring a CE mark. For CE marking IVDs, the classification groups fall under Annex II, List A; Annex II, List B; or self-testing. For CE marking medical devices, the classification is I, IIa, IIb, or III.
Next in the process is having a Quality Management System in place (generally ISO 13485), and preparing a CE Marking Technical File and a Clinical Evaluation Report. Preparing and compiling the correct documentation requires your CE marking professionals to exhibit great analytical and teamworking skills as they will need to liaise with different departments to successfully gather the required information. A specialist recruitment agency can narrow down candidates for you that display these vital characteristics so that you can hire the right CE marking professional to suit your needs.
What makes a great CE marking professional for medical devices?
A great medical devices CE marking professional is someone who has a broad skill set consisting of technical knowledge, excellent analysis and interpretation, strong communication and the right experience. CE marking professionals will have experience compiling technical documentation and working with the medical device directive or regulation, so having the right technical knowledge and experience will be important to suit your company’s needs. CE marking professionals will have experience in liaising with notified bodies, and in communicating with a team of individuals that will interpret regulation and prepare the various documents like clinical evaluation reports, design dossiers, and risk management files.
A great regulatory affairs specialist with CE marking experience will perform their part well, and also be able to ensure that all the correct documents are compiled correctly by the rest of the team so that the technical documentation is compliant throughout before being submitted to the relevant notified body for approval. When hiring for a CE mark professional it is also important to consider their experience and familiarity with medical device and IVD product classification, as well as their experience with ISO 13485 and Quality System management and Implementation.
Finding great medical device CE marking professionals
Finding the best of the best CE mark professionals can be a challenging task, as what separates the best CE regulatory affairs professionals from merely good ones is the ability to combine all of the aforementioned skills together in one package. Finding such a specific individual requires having access to a large network of CE mark professionals looking for new job opportunities – Elemed can help match your company with a top CE mark medical device professional that has the requested experience and skills that you are looking for. You can get in touch with our team today to discuss your hiring needs.
If you are struggling to find the right CE marking professional or if you are being tied down by budgetary constraints, you might wish to consider making an interim hire instead of a permanent one. We have expertise in this area and our team would be happy to discuss solutions that can allow you to be as flexible as possible. You can discuss hiring a contract CE marking professional with Elemed Interim.