New regulations on medical devices: factsheets for SME manufacturers

27 September 2018 - 12:48

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.