Survive Or thrive under the new EU Medical Device Regulations (EU MDR)
The changes to the current Medical Device Directives (MDD) to comply with the new European Medical Device Regulation (EU MDR) are significant and all-encompassing for the Medical Device Industry.
There are a substantial number of new rules that will affect almost every kind of product currently on the Medical Device market and the onus lies wholly with the Medical Device manufacturer to fulfil all the new requirements to justify retaining products on the market, or to get any new products to market.
It is expected that all costs associated with maintaining a portfolio of products will significantly increase and, unless companies have a very good model to fully analyse costs, many will be producing devices at little to negative margins without even realising.
The costs of ensuring compliance, then maintaining compliance will be significant. Getting there quickly is an absolute necessity if any company is to minimise the costs for EU MDR implementation and ongoing compliance. The vehicle to get there must be a company-wide approach, embraced by every section – it is no longer the domain of the RA department as was the case with MDD.
Explic8 Limited has the knowledge and experience to help you overcome the hurdle of achieving and maintaining EU MDR compliance. It is about adding value to the business by ensuring the implementation plan is carried out in the correct order – getting this wrong can drastically affect the company’s ongoing profitability and ability to achieve and maintain effective operations aligned to EU MDR. Getting it right will enable maximum ongoing margins and returning to “business as usual” in the shortest possible time.