The second edition of the standard ISO 37001:2025 was published in March 2025, replacing the previous edition, ISO 37001:2016 (ISO 37001:2016/Amd 01/2024).

A two-year transition period is currently underway to align management systems with the expanded requirements of ISO 37001:2025.

The period during which both editions of the standard are valid ends on February 28, 2027.

After this date, all certificates issued according to the ISO 37001:2016 standard will become invalid.

Organizations using ISO 37001:2016 should, during the transition period, adapt their anti-bribery management system to the expanded requirements of ISO 37001:2025 and undergo the UPGRADE to the new standard during a planned audit.

All organizations certified by 3EC International a. s. according to the ISO 37001:2016 will be contacted by the 3EC office on following procedure and ISO 37001:2025 upgrade process.

For more information, please do not hesitate to contact our office at info@3ec.sk.

Based on the economic results in 2023, 3EC International a. s. was evaluated as a Socially Responsible Company.

The Slovak Information and Marketing Company developed a model focused on economic impacts and perspective of stability of activities of commercial entities in Slovak Republic. From the total number of 345 769 evaluated entities, only 4,4% of companies met the demanding evaluation criteria. Among these, also our company was awarded the title Socially Responsible Company.

Dear Clients,

we would like to inform you about conditions for extension of the validity period of your EC certificates related to the medical devices, certified as per Directive 93/42/EEC as amended – the so-called “legacy devices”, stated in the recently adopted Regulation (EU) No. 2023/607 of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.

In order to automatically benefit from the extension of your EC certificate validity period related to the “legacy devices”, following conditions have to be cumulatively met before expiry of the mentioned EC certificates:

ü  no later than 26 May 2024, the manufacturer (or its authorised representative), has lodged a formal application with attachments as per Annex IX, point 2.1 of the MDR for conformity assessment in respect of a “legacy device“ covered by a EC certificate together with submission timeline of complete technical documentation prepared in line with Annex II and III of the MDR, and no later than 26 September 2024 we as the notified body and the manufacturer have signed a written agreement related to the conformity assessment of this „legacy device“ according to the MDR,

ü  no later than 26 May 2024, the manufacturer has put in place a quality management system (QMS) in accordance with MDR

ü  the “legacy device” must continue to comply with Directive 93/42/EEC as amended, as applicable,

ü  the „legacy device“ does not undergo significant changes in the design and intended purpose,

ü  the „legacy device“ does not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health.

If these requirements are fulfilled, we as a notified body will perform surveillance audits for the „legacy devices“ stated in the MDR written agreement (even for “legacy devices” where other MDD notified body issued EC certificate as per Directive 93/42/EEC as amended).

If these requirements are not fulfilled cumulatively, EC certificates related to “legacy device” do not remain valid after the end of the period indicated on certificates and only MDR certified medical devices may be placed on the market or put into service.

If your EC certificate has already expired before entry into force of the above mentioned Regulation and you did not sign the written agreement related to “legacy device” with notified body before the expiry date, you may ask competent authority for derogation from the applicable conformity assessment procedure in accordance with Article 59(1) MDR or 97(1) MDR.

In an effort to honor and appreciate the work of exceptional personalities working in the field of quality, the Slovak Society for Quality awards the SSQ Award for an extraordinary contribution to the development of quality in Slovakia and the Award for the development of international cooperation in the field of quality. The award is the highest individual recognition of individuals for an extraordinary contribution to the development of quality in Slovakia. 

Ing. Katarína Tomin Srdošová, PhD., CEO of 3EC International a.s. receives the Award for her Contribution to Quality at the 26th International Conference on the occasion of the World Day of Quality and European Week of Quality with the motto: “Passing the Next Frontier with Quality“.

According to the Art. 110 sec. 3 of the Regulation (EU) 2017/746 as amended (IVDR), devices with a certificate that was issued in accordance with Directive 98/79/EC and which is valid by virtue of paragraph 2 of this Article or devices for which the conformity assessment procedure pursuant to Directive 98/79/EC did not require the involvement of a notified body, for which a declaration of conformity was drawn up prior to 26 May 2022 in accordance with that Directive, and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, and which may be placed on the market or put into service until the following dates:

(a)  26 May 2025, for class D devices;

(b)  26 May 2026, for class C devices;

(c)  26 May 2027, for class B devices;

(d)  26 May 2027, for class A devices placed on the market in sterile condition,

(hereinafter referred to as “legacy devices“), shall meet requirements of this Regulation relating to:

which shall apply in place of the corresponding requirements in the Directive.

Therefore, during the IVDD and/ or QMS-MD audit of the manufacturer whom the art. 110 sec. 3 of IVDR is applicable for, Audit Team shall verify the conformity of the manufacturers QMS-MD and/ or device with the following requirements:

Post-market surveillance (PMS)

·         Manufacturer must implement a PMS system according to Article 78 (all mentioned articles are IVDR articles), with the exception of the aspects related to pre-market requirements that do not apply to “legacy devices”, as update of the safety and performance summary (Article 78(3)(d) IVDR),

·         PMS system according to Article 83 must be based on PMS plan according to Article 79,

·         As part of the manufacturer’s post-market surveillance system, the post-market performance follow-up (PMPF) requirements (Annex XIII, Part B, IVDR) should apply to ‘legacy devices’. That means that, under the IVDR, manufacturers need to “proactively collect and evaluate performance and relevant scientific data from the use of a device”. However, this does not mean that the manufacturer would have to draw up, retrospectively, a performance evaluation report in line with the IVDR as performance evaluation and its documentation according to the IVDR is a pre-market requirement not applicable to ‘legacy devices’.

·         As Directive 98/79/EC, contrary to the IVDR, does not provide for rules for the classification of devices in risk classes as specified in the IVDR, an appropriate distinction cannot be made between ‘legacy devices’ to which Article 80 IVDR (PMS report) and ‘legacy devices’ to which Article 81 IVDR (periodic safety update report, PSUR) apply. Therefore, Article 80 IVDR (PMS report) should, as a minimum requirement, apply to all legacy devices, unless a manufacturer of ‘legacy devices’ that will fall under class C or D voluntarily prepares a PSUR pursuant to Article 81,

·         Manufacturers must upload reports to the electronic vigilance and post-market surveillance system of the manufacturer according to Article 87 (in the absence of full functionality of EUDAMED, special transitional provisions shall apply in accordance with Art. 112, 113(3)(f) IVDR),

Market surveillance

·         Manufacturer shall be aware of the market surveillance activities of the competent authorities, the Member States and the Commission under Articles 88, 89, 91 – 95

·         Manufacturer must have a procedure in place to deal with devices which present an unacceptable risk to health and safety in accordance with Article 90

Vigilance

·         Manufacturers must report serious accidents and safety corrective actions in accordance with Article 82,

·         Manufacturers must report on trends according to Article 83,

·         Manufacturers must carry out analysis of serious accidents and safety corrective actions according to Article 84,

·         Manufacturers must be aware of the implementing acts according to Article 86

Registration of economic operators and of devices

·         Manufacturers must register their devices in accordance with Article 26 (in the absence of full functionality of EUDAMED, specific transitional provisions apply in accordance with Articles 112, 113(3)(f) IVDR),

·         Manufacturers, authorised representatives and importers have to register according to Article 28 (in the absence of full functionality of EUDAMED, specific transitional provisions apply in accordance with Article 112, 113(3)(f) IVDR),

 Verification of implementation

Audit Team shall verify during upcoming surveillance audits that manufacturers

·         conducted an extraordinary internal audit regarding implementation of applicable IVDR requirements,

·         demonstrate an objective evidence of implementation of abovementioned IVDR requirements (documents and records),

·         demonstrate competence of the IVDR requirements, e.g. IVDR Training,

·         conducted an extraordinary management review to verify implementation of above mentioned IVDR requirements.

We are pleased to inform you that 3EC International a.s. designation and notification process according to the Regulation (EU) 2017/746 on in vitro diagnostic medical devices was completed with publication of notification in the European Commission`s NANDO database. The current scope of designation and notification according to the Regulation (EU) 2017/746 is available at:

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=317359&version_no=3

In the following days our webpage will be updated with a section dedicated to the Regulation (EU) 2017/746 with all necessary forms and other mandatory published documents for applicants on conformity assessment according to the new regulation.

ased on the economic results in 2020, 3EC International a.s. was evaluated as a Socially Responsible Company.

The Slovak Information and Marketing Company developed a model focused on economic impacts and perspective of stability of activities of commercial entities in Slovak Republic. From the total number of 304 867 evaluated entities, only 2,41% of companies met the demanding evaluation criteria. Among these, also our company was awarded the title Socially Responsible Company.

3EC International wishes to inform you that we discovered that a new unknown subject 3EC International Certifications Private Limited was established on April 9, 2021 in New Delhi, India (Registration No. 379811, the Corporate Identification No. CIN U74999DL2021PTC379811, address House No. 2761, Gali Ram Roop Landmark Subzi Mandi, Delhi, 110008 India), which does not have anything in common with our NB 2265 and the certification company 3EC International a.s., 3EC International, s.r.o. (Czech republic) and may pose a threat to our activities on the world-wide markets and may mislead the customers in a harmful way and in the end harm the consumers.

In this way, we kindly ask you to take note of the above fact. We would appreciate receiving any information regarding the acts of this company which could damage our reputation or of acts misleading potential clients. Activities of the 3EC International Certifications Private Limited could lead to unfair competition and harm potential clients. If we find any illegal actions by 3EC International Certifications Private Limited we will take appropriate legal action to protect our company.

Based on the economic results in 2019, 3EC International a.s. was evaluated as a Socially Responsible Company.

The Slovak Information and Marketing Company developed a model focused on economic impacts and perspective of stability of activities of commercial entities in Slovak Republic. From the total number of 292 209 evaluated entities, only 3,33% of companies met the demanding evaluation criteria. Among these, also our company was awarded the title Socially Responsible Company.

We are pleased to inform you that 3EC International a.s. designation and notification process according to the Regulation (EU) 2017/745 on medical devices was completed with publication of notification in the European Commission`s NANDO database. The current scope of designation and notification according to the Regulation (EU) 2017/745 is available at:

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=308900&version_no=3

In the following days our webpage will be updated with a section dedicated to the Regulation (EU) 2017/745 with all necessary forms and other mandatory published documents for applicants on conformity assessment according to the new regulation.