It comes as no surprise to know that the need for ever-advancing medical device machinery in the modern world and progressively into the future that the human race, and most certainly in the medical health industry, is essential for survival. For the most part when people think of the health sector or the world of medicine they immediately jump to the conclusions of pharmaceuticals and bandages, and while those are important for treating ailments and illness, there are more significantly advanced pieces of equipment that could mean the difference between life and death.

The issue we face is not that there aren’t medical machines readily available for implementation into hospitals or clinical facilities, but rather gaining access to them. This is why companies that are struggling to get their ‘foot in the door’ -as the saying goes - when looking at the EU market, need to enlist the help of industry professionals and an EC rep is just the solution and the silver lining to navigating the tedious world of European regulations. 

EC reps – Their function and efficacy 

So you might be thinking, what is an EC rep and how can they assist me in my struggle.

Simply put, in order for a medical device manufacturer established outside of Europe to market its products within the European market, appointing an authorized representative is mandatory. This representative, known as an EC Rep, acts as the point of contact between the European Union regulatory authorities and the manufacturer.

Industry experts with years of professional experience behind them, such as CMC Medical Devices, provides a full ec rep service, ensuring complete compliance with the requirements established by the In Vitro Diagnostic Regulation (IVDR) and the Medical Device Regulation (MDR).

If you thought that having a medical representative act on your companies behalf when you could save financially and do the job yourself, in most cases after much struggles no doubt, the realization of benefits that they bring to the table far out measures any hesitation companies once had.

Take a look at these handful of advantages that having an ec rep in your corner can provide;

· Professional liaison – Communicating with National Competent Authorities on a regular basis can be exhausting, an ec rep does the leg work for you and maintains cooperation between you and your distributors.

· Document confidentiality – If required by law, and still then only to the appropriate competent authority, will your European Authorized Representative show your firms technical documentation.

· Files regularly updated – The Company’s technical reports and files are continuously updated and ready for inspections by European Competent Authorities as and when requested.

· Point of contact for the Field Safety Corrective Actions (FSCA) – Serious device mishaps or malfunctions are reported to the competent authorities by your ec rep, but they also take responsibility of reporting incidents should there be any between the distributors and your business.

· Reports maintained concerning data assessments – Confidential data collected during clinical evaluations are maintained for review by Competent Authorities so you can have peace of mind your paperwork is in order when the time calls.   

Supporting the growing need 

We are living in times where health is being prioritized more and with that comes the routines of regular checkups, screening for concerns that are best treated early, and for many people the habit of disease prevention. These are all valid matters but none that can necessarily be treated or diagnosed effectively without the help of modern medical device machinery. The need and demand is there so getting your products to the EU market is a must for the health of the future generations.

The opportunities and innovations possible with the advancements in technology is a big advantage to the medical industry, we need the machinery to put into play the plans of action.

Global markets and growing statistics indicate that by 2029 the need and value for medical devices will run as high as 1.145 trillion Euros ($1.3 trillion USD) at a CAGR (Compound Annual Growth Rate) of as much as 9.8%. Companies need to get their products into the EU Market, use a reliable and reputable ec rep to ensure all legalities and compliances are met, and keep the world healthier moving forward.

If the time to invest was now, then working with firms that offer full ec rep services for a seamless EU market integration, then this is an investment well worth every cent, and not a minute too soon.