Statutory Instruments

EUROPEAN UNION (MEDICAL DEVICES AND IN VITRO DIAGNOSTIC MEDICAL DEVICES) REGULATIONS 2017

The purpose of these Regulations is to designate the Health Products Regulatory Authority as the competent authority responsible for enforcing the following EU Regulations:

— Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, and
— Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices.

In addition, these Regulations confer additional powers under those EU Regulations on the Health Products Regulatory Authority and determine the language(s) to be used in the State under certain provisions in those EU Regulations.
These Regulations may be cited as the European Union (Medical Devices and In Vitro Diagnostic Medical Devices) Regulations 2017.

EUROPEAN UNION (MEDICAL DEVICES AND IN VITRO DIAGNOSTIC MEDICAL DEVICES) REGULATIONS 2017HEALTH SERVICES (DRUG PAYMENT SCHEME) REGULATIONS 2017