Immucor, Inc.

Checking device conformity before released. PMS obligations in Articles 10(9) & 78. Creating up-to-date technical documentation/EU DoC. Reporting obligations in Articles 82 to 86, including associated implementing acts of guidance adopted by MDCG. Issuing statement in Section 4.1 of Annex XIV for interventional clinical performance studies or other performance involving risks for the subjects.

Checking device conformity before released. PMS obligations in Articles 10(9) & 78. Creating up-to-date technical documentation/EU DoC. Reporting obligations in Articles 82 to 86, including associated implementing acts of guidance adopted by MDCG. Issuing statement in Section 4.1 of Annex XIV for interventional clinical performance studies or other performance involving risks for the subjects.

Checking device conformity before released. PMS obligations in Articles 10(9) & 78. Creating up-to-date technical documentation/EU DoC. Reporting obligations in Articles 82 to 86, including associated implementing acts of guidance adopted by MDCG. Issuing statement in Section 4.1 of Annex XIV for interventional clinical performance studies or other performance involving risks for the subjects.