There are 3 principal directives that are applicable to medical devices. These are the Medical Device Directive 93/42/EEC, the In Vitro Diagnostic Medical Devices Directive 98/79/EC and the Active Implantable Medical Devices Directive 90/385/EEC. If you have a medical device that you wish to market and put into use in the European Union you must comply with one of the medical device directives to have your product CE Market. Deciding which directive is applicable to your product will depend upon what your medical device is and what you claim your product is to be used for. High Edge Consulting can assist you in determining the correct medical device classification for your product and we can also help with borderline products that may be a medicinal or a Medical Device.
The full title is Directive 93/42/EEC and it covers placing medical devices on the market and putting them into service. The Medical Device Directive 93/42/EEC (known as the MDD) includes a wide range of medical devices from first aid plaster to valves, stents, glasses, proctoscopes, orthopedic implants, fetal scalp electrodes, forceps, scalpels and many many more. If the medical device directive is applicable to your product, then you must meet all the relevant essential requirements of the Medical Device Directive (MDD). The MDD has various annexes which depending upon your medical device you may have to adhere to particular annexes.
Directive 98/79/EC covers the placing of in vitro diagnostic medical devices on to the market and putting them into service. The In Vitro Diagnostic Medical Devices Directive 98/79/EC (known as the IVDD) includes are range of medical devices that are used in vitro for the examination of a specimen derived from the human body, including reagents, instruments and specimen receptacles. If the In Vitro Diagnostic Medical Devices Directive (IVDD) is applicable to your medical device, then you must meet all the essential requirements of it and the applicable annexes.
Directive 90/385/EEC covers the placing of active implantable medical devices on to the market and putting them into service. The Active Implantable Medical Devices Directive 90/385/EEC (known as the AIMDs) covers medical devices that are both active and implantable at the same time. Examples of AIMDs are pacemakers, ear implants, stimulators for nerves, bladders, diaphragm etc, implantable monitoring devices, active drug administrators that are implantable and many more. If the medical device is only implantable or only active it does not fall under the Active Implantable Medical Devices Directive. If the AIMDs is applicable to your medical device, then you must meet all the essential requirements of it and the applicable annexes.
Medical Devices is a specialist area and highly regulated. At High Edge Consulting we have specialists in medical devices who can work with you on your regulatory affairs. Our consultants have a wealth of experience in the medical device arena and can bring expertise and practical knowledge to your company. We can assist in classifying your product and determining whether a borderline product is a medical device or a medicinal and progress your regulatory affairs requirements accordingly. Whether you require assistance or guidance in implementing the Medical Device Directive, gaining the CE Mark, the Canadian Medical Device Regulations or FDA requirements for selling into the USA, our expertise can be with you every step of the way. Coupled with our other services including microbiology, validation and our extensive knowledge of sterilisation of medical devices we can offer realistic support to you in realising your medical device to market. Regulatory Affairs is part of a total solution we can provide to you.
The MDD and IVDD stipulate that you must have a quality system. It is often a misconception that it has to be a certified ISO 13485 or ISO 9001 system. Your quality system can be non-certified but it must fulfil the requirements for compliance of the Medical Device Directives. It is usual however for auditors to benchmark your quality system using ISO 13485.
In order to sell a medical device in any European country, the device must be CE Marked. This is a mandatory requirement and any breach is taken very seriously by the relevant Competent Authority, in the UK this is the MHRA. In order to achieve a CE Mark, you must comply with the relevant medical device directive. Many Medical Devices fall within the Medical Device Directive 93/42/EEC but there is also the Directive of In Vitro Diagnostic Medical Devices 98/79/EC and the Directive of Active Implantable Medical Devices 90/385/EEC. The route to achieving a CE Mark is not always straight forward. At High Edge Consulting we have particular expertise in the Medical Device Directive (MDD), the In Vitro Diagnostic Medical Devices Directive (IVDD) and CE Marking.
Utilising our thorough knowledge, we can assist with all aspects of ensuring compliance with the MDD and IVDD from assisting with classification of your medical device, give guidance on the conformity assessment route to be selected, interpret the essential requirements and ensuring they are fulfilled, authoring technical files, properly evaluate your clinical data and give advice where additional clinical data is required, ensure your post marketing surveillance and vigilance are integrated into your quality system and not misinterpreted leading to major non conformances and so on. At High Edge Consulting we are able to provide just advice if that is all you require or we can provide practical hands on support for you in the preparation of relevant documentation.. Working from start to finish we help you through to compliance every step of the way.
If you are intending to sell your medical device into Canada, you must comply with the Canadian Medical Device Regulations SOR/98 282. Our Consultants have worked with companies to ensure compliance. Compliance of the Canadian Medical Device Regulations SOR/98 282 includes: having a certified ISO 13485:2003 Quality Management System; ensuring your quality system has the requirements of SOR/98 282 fully integrated into it; and The third party body you choose for tour Canadian Medical Devices Conformity Assessment System (CMDCAS) audit is an “Accredited Registrar†by the Standards Council of Canada. High Edge Consulting can assist you through the regulatory process relating to SOR/98 282.
In order to sell medical devices into the USA, you must comply with Food and Drug Administration regulations. This requires detailed specialist knowledge of Title 21 CFR Part 820 – Quality Systems Regulations. Our comprehensive knowledge of Title 21 CFR Part 820 and consultants with full understanding of FDA regulations, we can assist you with the other regulatory requirements such as 510K applications, Pre-Market Approval (PMA) applications, Establishing Registration, Responding to any 483s or Warning Letters and give you guidance in how best to receive a n FDA investigation. Our experience is unquestionable
