Briefs

Danish Regulator to Double Device Unit Staffing, Launch Analytics Center

The Danish Medicines Agency will more than double the staff in its medical devices unit in 2020 as it aims to “massively build up capacity.”

The agency is also establishing a new medical device data analytics center to better handle the growing volume of data to monitor devices under real world conditions. The center will be the first of its kind in Europe, the agency said.

In addition, the center will set a regulatory framework for data in terms of how they are obtained, protected and used in the interest of public health and in line with “data-ethical standards,” it said.

The move comes at a time when the industry is quickly evolving with new products and technologies such as 3D printing emerging, but it also is a response to the EU Medical Device Regulation that comes into force next year.

The unit is reorganizing into four teams including: an international collaboration team; a premarket team to handle notified bodies, approval of clinical trials and applications for exemption; a team responsible for medical devices on the market, including registration of manufacturers, and market surveillance.

India’s CDSCO to Regulate All Devices by Year End

India’s Ministry of Health and Family Welfare reported that all medical devices will officially be overseen by the Central Drugs Standard Control Organization by the end of 2019.

Under the provisions of the 2017 medical devices rules, all foreign devicemakers must comply with conformity assessment requirements, which means obtaining a conformity assessment certificate and registering their devices on the National Register of Medical Devices before they can be marketed in the country.

In addition, a draft law proposes compensation to patients for faulty medical devices. The Medical Devices Bill 2019 applies to all locally made and imported medical devices. The draft law includes penalties and jail terms for placing a device on the market without a conformity assessment certificate.

EU’s Medical Device Coordination Group Promises 50 Guidances on EU MDR

The European Commission’s Medical Device Coordination Group plans to release 50 guidance documents on the EU Medical Device Regulation and the In Vitro Diagnostic Regulation.

Most of the documents will cover oversight of notified bodies and clinical investigations. Several documents in the works relate to unique device identification, including integration of UDI in devicemakers’ quality management plans, and guidelines on specific product types.

Other guidances are expected on nomenclature. One on standards and one for market surveillance for Class I devicemakers is expected before year end.

Read the full list her: www.fdanews.com/11-07-19-guidance.pdf.