Commission Implementing Decision (EU) 2021/611 of 14 April 2021 amending Implementing Decision (EU) 2020/438 as regards harmonised standards on biological evaluation of medical devices, packaging for terminally sterilised medical devices, sterilisation of health care products and clinical investigation of medical devices for human subjects

• CELEX: Implementing Decision (EU) 2021/611
• Articles: 3

Article 1

Annex I to Implementing Decision (EU) 2020/438 is amended in accordance with the Annex to this Decision.

Article 2

This Decision shall enter into force on the day of its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX

ANNEX

Annex I is amended as follows:

(1)

entry 14 is replaced by the following:

No

Reference of the standard

‘14.

EN ISO 10993-16:2017

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)’

(2)

entry 16 is replaced by the following:

No

Reference of the standard

‘16.

EN ISO 10993-18:2020

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)’

(3)

entry 23 is replaced by the following:

No

Reference of the standard

‘23.

EN ISO 11607-1:2020

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)’

(4)

entry 25 is replaced by the following:

No

Reference of the standard

‘25.

EN ISO 11737-2:2020

Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)’

(5)

entry 34 is replaced by the following:

No

Reference of the standard

‘34.

EN ISO 14155:2020

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)’

(6)

the following entry 47 is added:

No

Reference of the standard

‘47.

EN ISO 11607-2:2020

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)’