Technical testing and toxicological testing of medical devices should be carried out in a testing laboratory with the appropriate scope of accreditation. Information on the accreditation of the laboratory can be found in the general access on the website of the Federal Service for Accreditation (RusAccreditation).

How to check the scope of laboratory accreditation:

1. Visit the RusAccreditation website in the section of the register of accredited persons https://pub.fsa.gov.ru/ral
2. Install the required filters (e.g. laboratory name/address/description of accreditation field, etc.).
3. Check that the area of the accreditation certificate corresponds to the search requirements (the laboratory should be accredited for the standards applicable to the registered product)

What you need to pay attention to:

There is a very important column in the register — “status”. For each accreditation certificate there are five possible statuses.

1) Valid . The laboratory may conduct tests in accordance with its area of expertise in full.

2) Partially suspended . In the course of monitoring the laboratory’s activities inconsistencies were revealed. Accreditation is suspended in relation to part of the area until the identified non-compliance is rectified. If after the suspension of the accreditation certificate the laboratory has not rectified the non-compliance within the established term, the scope of accreditation shall be reduced.

3) Suspended . In the course of monitoring the laboratory’s activities inconsistencies were revealed. Accreditation shall be suspended until the identified non-conformity is fully rectified.

4) Discontinued . The laboratory lost its accreditation. This happens if after the suspension of the accreditation certificate the laboratory has not eliminated the non-conformity within the established period of time (the validity of the accreditation certificate was suspended completely, and not for part of the area).

5) Archive . The laboratory’s accreditation certificate expired.

When selecting a testing laboratory, it is important that the accreditation status is defined as “valid”.

Current problems:

The number of laboratories that have accreditation applicable to medical devices is very small, both in Moscow and throughout Russia. Moreover, the number of laboratories that have a wide scope of accreditation, allowing tests to be conducted for almost any medical device, can be counted almost on the fingers of one hand.

Since the end of 2018, a serious problem has become more acute — cases of suspension/termination of laboratory accreditation have become more frequent.

Below is a list of large laboratories that have encountered this problem:

• Testing laboratory of medical devices of the Federal State Budgetary Institution “Federal Scientific — Clinical Center for Physical and Chemical Medicine of the Federal Medical and Biological Agency” (IL MI FSBI FNCK FKhM FMBA of Russia) — a laboratory that has an accreditation area for toxicological and technical testing of a wide range of medical devices (disposable products, instruments, medical equipment, in vitro diagnostics, etc.). Starting from 02-07-2019, the decision was taken to terminate the accreditation.
• Testing Laboratory of NIIMT JSC — a laboratory having the area of accreditation for conducting technical testing of a wide range of medical devices (disposable products, instruments, medical equipments). Starting from 02-21-2019, the decision was taken to suspend the accreditation, but on 08-01-2019, the accreditation was renewed.
• IL TSB LLC “Electrontest” — a laboratory having the area of accreditation for conducting technical testing of a wide range of medical devices (disposable products, instruments, medical equipment, in vitro diagnostics, etc.). Starting from 08-06-2019, the decision was taken to suspend the accreditation. At the moment, this situation has not changed
• Testing Center IMN FGBUN IT FMBA of Russia — a laboratory with accreditation for toxicological testing of medical devices. Starting from 10-22-2019, the decision was taken to suspend the accreditation. At the moment, this situation has not changed
• IL EMC TS “VNIIFTRI-TEST” — a laboratory that has the area of accreditation for conducting electromagnetic compatibility testing of medical devices. Starting from 10-11-2019, the decision was taken to terminate the accreditation.
• IC LLC “TsSMI VNIIMP” — a laboratory that has the area of accreditation for conducting technical testing of medical devices. Starting from 12-14-12018, the decision was taken to terminate the accreditation.

This list of laboratories is far from finite. And now the main question is “Who is next?”

Note: The procedure for suspension and renewal of accreditation, and the procedure for reducing and expanding the scope of accreditation can be found by studying the Federal Law N 412-FZ dated 12-28-2013 (as amended on 29-07-2018) “On accreditation in the national accreditation system” (as amended and added to, which entered into force on 01-27-2019).