European Commission PRESS RELEASES Press release. Ranging from simple contact lenses and sticking plasters to sophisticated pacemakers and hip replacements, medical devices and in vitro diagnostic medical devices are important to our health and quality of life. People rely on these devices every day and expect them to be safe and incorporate the latest progress in science and innovation. The current rules on the safety and performance of medical devices in the EU were harmonised in the 1. To reflect the substantial technological and scientific progress in this sector over the last 2. Commission proposed to update the rules to improve the safety of medical devices for EU citizens, create the conditions to modernise the sector and to consolidate its role as a global leader. Why do we need new regulations on medical devicesProblems with diverging interpretation of the existing rules as well as certain incidents e. To address this, the Commission proposed two Regulations on medical devices and in vitro diagnostic medical devices in 2. To ensure harmonised application of the rules throughout the EU, the two new Regulations will replace the three existing Directives on medical devices. The new rules significantly tighten the controls to ensure that medical devices are safe and effective and at the same time foster innovation and improve the competitiveness of the medical device sector. The new rules also better reflect the most recent scientific and technological progress and set the gold standard for medical device regulation globally. Eu Medical Device Regulation Updates' title='Eu Medical Device Regulation Updates' />The Commission welcomes the adoption of its proposal for two Regulations on medical devices which establish a modernised and more robust EU legislative framework to. EU Medical Device Roadshow. Join BSI experts at our full day EU Medical Device Roadshow where you can learn about some of the most significant evolving European. The revised rules also provide the conditions needed to consolidate the role of the EU in the long term as a global leader in the sector. What are the main benefits for patients and consumers The new Regulations pave the way to a more patient friendly environment, where transparency and patients information and choice are a priority where patients can benefit from innovative, highly performing devices and new therapies become possible. The new rules introduce better protection of public health and patient safety. In particular high risk devices are going to be subject to stricter pre market control. Certain aesthetic devices such as coloured contact lenses or equipment for liposuction presenting high risk to consumers and practices such as reprocessing of single use devices are included in the scope of the new Regulations and made subject to a stricter and more harmonised regime. Rules on clinical evaluation and clinical investigation and, for in vitro diagnostic medical devices, performance studies are generally strengthened and stricter requirements on the use of hazardous substances are introduced. EU database on medical devices EUDAMED that will contain a living picture of the lifecycle of all products being available on the EU market. A large part of the information will be made publicly available, including a newly introduced summary of safety and performance for all Class III and implantable devices. The Commission is required to set up the database by spring 2. UDI that will allow easier traceability of medical devices,an implant card for patients containing information about implanted medical devices that will make information easily available and accessible to the particular patient. The Regulations require manufacturers to have measures in place to provide sufficient financial coverage in respect of their potential liability. Such financial coverage shall be proportionate to the risk class, type of device and the size of the enterprise. This should allow patients to be rapidly and effectively compensated, also in case of financial bankruptcy of the relevant company. Standards. The following is a list of the 20 latest published ETSI standards under the Radio Equipment Directive 201453EU. For only those already cited in the. EU combinations The impact of the new Medical Device Regulation on devicedrug and drugdevice combination products in Europe. Medical Devices Current Good Manufacturing Practice CGMP Final Rule Quality System Regulation. The purpose of the ECMO is to promote within the European Union and the European Free Trade Association the practice of high quality medicine respectful of patients. Which products are affected by the new regulations In line with the current system, all medical devices, in vitro diagnostic medical devices and their accessories fall under the new regulations. In addition, certain aesthetic products such as coloured contact lenses or equipment for liposuction that need to be just as safe as existing medical devices will also be covered. Under the new Regulations, both medical devices and in vitro diagnostic medical devices are divided into four risk classes. Depending on the risk class of the product, a different conformity assessment procedure is foreseen before the product can be placed on the EU market. In case of medium or high risk classes, Notified Bodies might be involved in the process. Why did an agreement take so long to reach Effective and efficient rules on medical devices are extremely important to ensuring high levels of health and safety protection for EU citizens. At the same time, they are very technical and sensitive, and they had to be considered thoroughly. After three years of discussions at the expert level, the ministers of all EU countries agreed on 5 October 2. The European Parliament and the Council agreed on a final text on 1. June 2. 01. 6. Based on this agreement and following the legal linguistic finalisation of the text, the Council voted its first reading position for the two texts on 7 March 2. The same texts were then adopted without modification by the European Parliament with an early second reading on 5 April 2. The new rules will now start to apply 3 years after publication of the Regulation for medical devices and 5 years after publication for in vitro diagnostic medical devices. New requirements on Notified Bodies and the provisions of the new governance structure will already be applicable six months after the adoption, therefore by the end of this year. European authorized representative in the medical device industry for MDD, IVDD, AIMDD and European regulatory affairs, CE Mark MDSS is located in the center of Europe. MHRA_-_Certificate_Validity_960x640.png' alt='Eu Medical Device Regulation Updates' title='Eu Medical Device Regulation Updates' />Will the new rules be able to keep up with the future progress The final Regulations contain very important changes to the current system to enable the sector to produce safer and more innovative devices and help address future challenges. The new Regulations contain many provisions to increase security and regulatory certainty harmonised rules on drug device combination products, tissue engineering, nanoscience, personalised medicine, substance based devices and genetic tests and take into account the latest developments in the sector medical software, apps, cybersecurity. To help boost innovation in the sector, the EU wide database on medical devices EUDAMED, supported by a new device identification system based on a unique device identifier UDI, will make big sets of data in the field of medical devices available within the EU. By producing more innovative devices, medical device manufacturers will also be able to offer solutions for disease prevention or early diagnosis that will in turn make the healthcare sector more affordable, by for example helping to prevent or reduce hospitalisation. Will the transition to the new rules create any disruptions to the availability of medical devices What are the arrangements It is crucial to ensure that the new rules enter into force without any unreasonable delays and they do not create any serious disruption of the medical devices supply. The Commission, competent Authorities, Notified Bodies and all other stakeholders will work together to ensure that the transition to the new regime is smooth and successful. The Regulations foresee that certificates issued under the current Directives can remain valid for a certain additional period after the general application date of the two Regulations 3 years after the entry into force for medical devices and 5 years for the in vitro diagnostic medical devices. Moreover, a set of exemptions from clinical investigation requirements have been introduced for products placed on the market under the current Directives, provided that their clinical evaluation is based on sufficient clinical data and that they are in compliance with relevant common specifications. These regulatory developments will also create new opportunities for qualified staff. The Commission will work with stakeholder organisations and Member states authorities to organise relevant information and training within their constituencies required to carry out these changes. Decide if your product is a medicine or a medical device. Overview. Some products are hard to distinguish from a medicine or a medical device, for example cosmetics, food supplements or biocidal products. These products are called borderline products until their status has been decided. MHRA determines whether a product falls within the definition of a medicine medicinal product or a medical device and provides information on whether a product is a medicine or a medical device or not. Types of borderline products. The types of products which may fall in to the borderline category include cosmeticsfood products, including, in particular, food supplementsherbal productsmedical devicesbiocidesmachinerylaboratory equipment. There is also a borderline between medicinal products and medical devices. In these cases it will be the claims being made and the mode of action that will decide which regulatory regime will apply. Borderline medicines. A medicinal product is any substance or combination of substances presented as having properties of preventing or treating disease in human beingsany substance or combination of substances that may be used by or administered to human beings with a view to restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action, or making a medical diagnosis. You can find more detailed information in Regulation 2 of the Human Medicines Regulations. Food supplements that contain familiar substances like vitamins, amino acids or minerals are generally subject to food safety and food labelling legislation rather than medicines control. You can get advice on food and cosmetics from the Trading Standards Institute. MHRA decides whether the claims that are made or the active substances present would mean that the product is regarded to be a medicinal product. The inclusion of herbal or natural ingredients does not exclude a product from being a medicinal product. MHRA takes the same factors into account when deciding the status of a product with herbal ingredients. How we decide if a product is a medicine. MHRA decides whether a product is a medicine when the manufacturer is not sure if their product is a medicine or not, and they come to MHRA for advice. MHRA receives a complaint that a product is being marketed as a medicine but does not have a marketing authorisation formerly a product licenceWe look at the claims about what the product does explicit and implicitthe pharmacological, metabolic or immunological properties of the ingredients this includes any herbal ingredientsthe primary intended purpose of the productwhether there are any similar licensed or registered products on the markethow it is presented to the public through labelling, packaging, promotional literature and advertisements. See final determinations by MHRA on borderline products February 2. MS Word Document, 2. KB. See final determinations by MHRA on borderline products October 2. July 2. 01. 4. PDF, 1. KB, 1. 8 pages. Previous final determinations are available on the National Archives. See Urgent Notices issued by MHRA from June 2. PDF, 8. 9. 1. KB, 6 pages. Adobe Flash Player Bad Performance Evaluations. Borderline medical devices. Medical devices fall into 1 of 3 categories, as each type is governed by a different EU directive MHRA can give advice if you are not sure which category your device fits into. You should not assume that if your product is considered a medical device in countries outside the EU that it will be a medical device in the EU as well. Decisions about whether a product is a medical device are based on the stated intended purpose of the product and its mode of action. If the product is a medical device, the principal intended action is fulfilled by physical means. Getting advice about your product. Borderline medicines. You can find detailed advice here in our a guide to what is a medicinal product. PDF, 6. 78. KB, 6. You should read this document before contacting MHRA. Use our borderline advice form form to request information on a medicine if you dont find the information you need in our guidance document. Email the completed form and attachments to borderlinemedicinemhra. MHRA will only respond to a maximum of 3 product enquiries at a time. Borderline medical devices. If your enquiry is about the regulatory route for a medical device you should email Devices. Further guidance. Borderline products, drug delivery products and medical devices incorporating, as an integral part, an ancillary medicinal. Borderlines between medical devices and medicinal products. PDF, 1. 66. KB, 1. Medicines borderlines. Borderline medicines and the internet. Medical products containing herbal ingredients. PDF, 3. 2. 8. KB, 5 pages. List of herbal ingredients and their reported uses. PDF, 4. 29. KB, 1. Medical device borderlines. Guidance on standalone software including appsBorderlines between medical devices and other products such as personal protective equipment, cosmetics and biocides. PDF, 1. 29. KB, 1. European Commission Guidance documents MEDDEVs.