Bosnia and Herzegovina Guidance on Transitional Requirements

Table of content

The article provides clarifications regarding the transitional arrangements associated with the changes in the legal framework. The article is dedicated to the guidelines on Conditions and Procedures for Recognizing EC Certificates of Conformity for Medical Devices Due to the Transition from EU Directives (MDD/AIMD) to EU Regulation (MDR). The document outlines the key points to be taken into consideration by medical device manufacturers and other parties involved in placing medical devices on the market. 

Taking into account Article 120 of Regulation (EU) 2017/745 (as amended by Regulations (EU) 2020/561 and (EU) 2023/607), which establishes a transitional period for medical devices to comply with its requirements, as well as Articles 100 and 101 of the Law on Medicines and Medical Devices (Official Gazette of BiH 58/08) and Article 68 of the Rulebook on Medical Devices (Official Gazette of BiH 04/10), the following procedures will apply for recognizing EC certificates of conformity:

Recognition of EC Certificates

EC certificates issued by a notified body in accordance with Directives 90/385/EEC and 93/42/EEC before May 25, 2017, and valid as of May 26, 2021 (when the EU MDR regulation came into effect), shall remain valid beyond their original expiration dates, provided they have not been subsequently revoked.

The extended validity applies as follows:

(a) Until December 31, 2027, for:

• Class III medical devices
• Implantable Class IIb medical devices (excluding sutures, clips, dental fillings, orthodontic appliances, dental restorations, screws, pins, plates, wires, needles, staples, and connectors)
• Active implantable medical devices (AIMD)

(b) Until December 31, 2028, for:

• Class IIb medical devices not covered under point (a)
• Class IIa medical devices
• Class I medical devices placed on the market in sterile conditions or with a measuring function

Market Placement and Use Conditions

Medical devices mentioned in the previous section can be placed on the market or used until the specified dates only if the following conditions are met:

1. The medical device remains compliant with Directive 90/385/EEC or Directive 93/42/EEC.
2. No significant changes have been made to the design or intended purpose of the device.
3. The device does not pose an unacceptable risk to patient health, user safety, or other aspects of healthcare.
4. By May 26, 2024, the manufacturer must establish a quality management system in accordance with Article 10(9) of the EU MDR regulation.
5. By May 26, 2024, the manufacturer must submit a formal application to a notified body for conformity assessment of the medical device listed in the previous section or a replacement device. Furthermore, by September 26, 2024, the manufacturer and the notified body must have signed a written agreement in accordance with Annex VII of the EU MDR regulation.

Required Documentation for Recognition

For recognition of EC certificates under the transitional provisions, the following documents must be submitted:

1. EC Certificate of Conformity issued by a notified body in accordance with Directives 90/385/EEC or 93/42/EEC before May 25, 2017. The document must have been valid on May 26, 2021, and not subsequently revoked. Submission of either the original or a certified copy is required.
2. Document from the Notified Body – confirms that the manufacturer has submitted a formal application to a notified body for conformity assessment; verifies that the manufacturer and the notified body have signed a written agreement in accordance with Annex VII of the EU MDR regulation. Submission of either the original or a certified copy is required.
3. Manufacturer’s Declaration issued by the medical device manufacturer. Must confirm the following:
   1. The device does not pose an unacceptable risk to patients, users, or public health.
      Submission of either the original or a certified copy is required.
   2. No significant changes have been made to the design or intended purpose of the medical device.
   3. Obligations of Manufacturers and Authorized Representatives

According to Article 70 of the Rulebook on Medical Devices (Official Gazette of BiH 04/10), manufacturers and their authorized representatives are responsible for ensuring the regular renewal of expired documentation related to their devices. Failure to comply with these obligations may result in restrictions on market access and regulatory penalties.

Conclusion

In summary, these guidelines establish the conditions and requirements for the continued recognition of EC certificates of conformity during the transition from the EU Medical Device Directives (MDD/AIMD) to the EU Medical Device Regulation (MDR). Manufacturers and stakeholders must ensure compliance with the specified deadlines and documentation requirements in order to be allowed to offer their products on the market after the regulatory changes taking place.

Source

https://almbih.gov.ba/wp-content/uploads/2025/02/Uputstvo-o-uslovima-i-nacinu-prizn[%E2%80%A6]usljed-prelaska-EU-direktiva-MDD-AIMD-na-EU-regulativu-MDR.pdf

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