iPoint Blog
EU Regulation of Medical Devices – MDR

The new EU Regulation of Medical Devices – MDR

Is your company and your supply chain ready to tackle the new EU MDR requirements? Get prepared for the 7 major changes in Medical Device Regulation.

Update: The European Commission has postponed by one year the date of application of the Medical Devices Regulation (MDR) till 2021, “to allow member states, health institutions and economic operators to prioritise the fight against the coronavirus pandemic.”

The Medical Device Regulation (MDR, (EU) 2017/745) will  now essentially apply in the European Union (EU) from May 26th of 2021.  The new MDR (EU 2017/745) will bring in a new wave of extended requirements for ‘medical devices’ produced, sold, and distributed in the European Union that all Medical Device manufacturers need to adhere to. Previously, medical devices came under the scope of two separate directives; the Medical Device Directive 93/42/EEC; and Active Implantable Medical Device Directive 90/385/EEC.

How does the MDR, (EU) 2017/745) affect my company and my supply chain?

What these changes in the regulation of ‘medical devices’ mean to you as a manufacturer, importer, or distributor and how they will affect your supply chain, will depend on a number of factors:

  • Which kind of products do you manufacture/sell?
  • What are the intended purposes of these products?
  • What will be the duration of use of the products?

In our  new white paper we briefly explain what constitutes a medical device (MD) and how the new regulation will affect placing on the market, conformity assessment, and market surveillance of products in the European Union (EU). Unlike previous regulations, MDR obligates that manufacturers of medical devices track their products throughout the active life, including after they have been sold to customers.

It is something complete new in the field of regulatory compliance for ‘medical devices’.

The Medical Device Regulation (EU) 2017/745 is a regulation taking a manufacturer’s obligation concerning their products further than in any previous regulation. The legal regulatory requirements of a ‘medical device’ from the point of manufacture, to that product’s end of life have been significantly expanded. As a medical device manufacturer, it is your obligation to be ready to tackle the upcoming changes. Not only that; you will also need to build and maintain proper post-market surveillance program. This is something complete new in the field of regulatory compliance for ‘medical devices’.

MDR White Paper – How to get prepared for the 7 major changes in Medical Device Regulation.

Several global companies from the Medical Device industry like Becton Dickinson, Roche, Emerson or Zimmer Biomet are longterm customers of iPoint and rely on our software solutions in the field of compliance, risk and sustainability. Those relationships provide us with detailed industry insights but we also keep an eye on the market trends in 2020 to develope the best software solutions possible to serve the specific needs of the Medical Device Industry.

Marcos Medalla

Add comment