New regulations on medical devices: factsheets for SME manufacturers

The European Commission has adopted new regulations on the manufacturing of medical devices and in-vitro diagnostic devices across the EU.

Why the change?

The new rules are designed to bring EU legislation into line with:

• technical advances
• changes in medical science
• progress in law making

What will change?

The new regulations aim to modernise the current system by introducing:

• stricter ex-ante control for high-risk devices
• a new risk classification system
• improved transparency through a device traceability system
• an “implant card” containing information about a patient’s implanted medical devices
• reinforced rules on clinical evidence
• strengthened post-market surveillance requirements for manufacturers
• improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance

When will it happen?

The regulations will enter into force following a transitional period of three years for medical devices and five years for in-vitro diagnostic devices.

How can SMEs prepare?

Understanding and adapting to regulatory changes can be a big challenge for small businesses. This is why the Enterprise Europe Network’s Healthcare Sector Group and the Single Market Thematic Group teamed-up with officials at the European Commission’s DG GROW to develop a handy and informative fact sheet. It has been prepared with SMEs in mind and aims to provide clear information on what the changes mean and how to prepare on time.

What happens next?

Later this year, the European Commission will launch a campaign aiming to alert SMEs to changes in legislation and help them to prepare for when they enter into force in 2020 and 2022. Further news on the campaign and a dedicated website will be available in the Autumn.

Learn more

The new regulations in a nutshell.

Take a look at the new factsheets available online.

source: European Commission

You may also be interested by :

Bird & Bird White Paper on the New Regulations The Changing Face of Medical Devices and In Vitro Diagnostic Medical Devices: Bird & Bird White Paper on the New…

A project in the health sector: what is the sector like? Launching a project requires a lot of knowledge of the sector in which you are launching yourself. It is true…

What are ISO norms? Is ISO applicable to medical devices? There are plenty of ISO norms (International Organization for Standardization) who, depending on the industry and activities, aim to define…

The BLSI business incubator launches a first in… The Brussels Life Science Incubator (BLSI) provides candidate entrepreneurs with a brand-new coworking space devoted to medical devices so that…

What is or can be protected when it comes to my product? The question on what precisely can be protected when it comes to innovation products, is really a crucial one, especially…

Is my solution a Medical Device? Or E-health? Whenever you develop a product in the Health sector, it is important to determine whether it falls in the category…