• EU Medical Devices Regulations

Weekly Compliance Digest – EU Medical Devices Regulations

July 1, 2016 By
In this edition of the Weekly Compliance Digest, we cover two proposed regulations in the European Union (EU) on medical devices.

Proposed Regulations on Medical Devices and In Vitro Diagnostic Medical Devices

What is it?

On June 15, 2016, The European Parliament’s Health Committee and the European Council’s Permanent Representatives Committee endorsed two new EU regulations on medical devices. The two draft regulations were part of an agreement reached on May 25, 2016 between the Netherlands presidency of the Council and representatives of the European Parliament. They include stricter monitoring and certification procedures to ensure full compliance and traceability of medical devices.

There are two separate regulations: one for medical devices (e.g. hip implants, joint replacements, insulin pumps, pacemakers), and another for in vitro diagnostic medical devices (IVDs). IVDs are medical devices that are not in direct contact with the patient, but provide information on a person’s health, such as HIV, DNA or blood test devices.

The two new regulations aim to make sure that medical devices and IVDs are safe, while allowing patients to benefit from innovative health care solutions in a timely manner. The regulations also aim to offer manufacturers the right legal framework to manufacture the devices that are asked by patients, according to Edith Schippers, Minister of Health of the Netherlands. The regulations would also tighten the rules for the independent bodies that are responsible for assessing medical devices before they can be placed on the market. The new rules will strengthen the surveillance of these so-called “notified bodies” by national authorities.

What are the requirements?

The two proposed regulations include the following provisions that affect manufacturers of medical devices and IVRs that are placed on the EU market:

  • Random inspections of manufacturers’ facilities after devices have been placed on the market.
  • Additional safety checking procedure for high-risk devices before they are authorized, such as implants or HIV-tests. Not only a notified body, but also a special committee of experts will check that all requirements are met.
  • Manufacturers will have to provide clinical evidence of medical device safety, especially in the case of higher risk classes.
  • Manufacturers will have responsibilities for the follow-up of the quality, performance and safety of devices placed on the market. This will allow manufacturers to act swiftly when concerns arise and help them to improve their devices continuously on the basis of actual data, according to the European Council.

The regulations also include the following provisions designed to improve patient safety:

  • A unique identification number for medical devices to improve their traceability. The objective is to allow fast and effective measures in case of safety problems. In addition, patients would receive an “implant card”, enabling patients and doctors to track which products have been implanted.
  • The creation of a central database to provide patients, healthcare professionals and the public with comprehensive information on products available in the EU.

What is next?

The next step is for the European Parliament’s Committee on Environment, Public Health and Food Safety (ENVI Committee) to confirm the agreement reached between the European Parliament and the European Council’s Permanent Representatives Committee. This is planned for September 2016, once the draft regulations have been translated into all official languages. Following the revision of the texts by the lawyer-linguists, the two regulations will have to be formally adopted by the Council and the Parliament, probably at the end of the year or in early 2017. The new rules will apply three years after publication for medical devices, and five years after publication for in vitro diagnostic medical devices.

More information

Here are links to more information on the two proposed EU regulations on medical devices:

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Categories: EHS

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