News
Changes in reimbursement of orthopedic technical devices and medical devices
From 4 August 2023, amendments to the Description of the Procedure for Reimbursement of Orthopedic Technical Devices and Medical Devices from the Budget of the Compulsory Health Insurance Fund, approved by Order No. V-234 of the Minister of Health of the Republic of Lithuania of 31 March 2006 (hereinafter referred to as the Description), regulating the documents certifying the conformity of enterprises manufacturing orthopedic technical devices and medical devices with the quality requirements set out in Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC. Regulation (EC) No. 178/2002 and Regulation (EC) No. 1223/2009. and repealing Council Directives 90/385/EEC and 93/42/EEC (hereinafter referred to as the Regulation), entered into force. The main amendments are:
“[...] 741. Together with the orthopedic technical device, the insured person must be issued with instructions for using this device. The instructions, in addition to information about the orthopedic technical device and the orthopedic company, provide information on where to contact if the issued orthopedic technical device is not satisfactory: during the period of use of this device, the orthopedic company should be contacted first. If the insured person is not satisfied with the orthopedic company's response, he or she may file a complaint regarding the quality of the orthopedic technical device with the VASPVT.
UAB „Sertika“ specialists can help with:a) assist in preparing instructions for use that comply with the requirements of the Regulation and standards;
b) perform a gap analysis, identifying missing elements in the already prepared instruction manual;
c) conduct internal training on the requirements of the Regulation and related standards for instructions for use.
The preliminary deadline for preparing the instructions for use is about 4 weeks.
742. All issued orthopedic technical devices must be labeled. The label must contain all the data specified in the Regulation.
UAB „Sertika“ specialists can help with:a) assist in preparing a medical device label that meets the requirements of the Regulation and standards,
b) perform a gap analysis, identifying missing elements in an already prepared label;
c) conduct internal training on the requirements of the Regulation and related standards for the label.
The preliminary deadline for preparing the instructions for use is about 2 weeks.
931. Orthopaedic companies established in the Republic of Lithuania that manufacture orthopedic technical devices shall submit a post-market surveillance report to the VASPVT by 10 January of the current year in accordance with Article 85 of the Regulation.
UAB „Sertika“ specialists can help with:a) assist in the preparation of the post-market surveillance plan and report;
b) conduct internal training on the requirements of the Regulation and related standards for the post-market surveillance plan, report and information collection.
The preliminary deadline for preparing the post-market surveillance plan is approximately 2 weeks, and the deadline for preparing the report is 2 weeks.
[...]
Annex 6 to the Procedure for Reimbursement of Orthopedic Technical Devices and Medical Devices from the Budget of the Compulsory Health Insurance Fund:
[...] The documents of the quality management system, to which the requirements are set out in Article 10(9) of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009, and repealing Council Directives 90/385/EEC and 93/42/EEC (hereinafter referred to as the Regulation);
UAB „Sertika“ specialists can help with:a) conduct a gap analysis of the organization's management system, identifying missing elements in accordance with the provisions of Article 10, paragraph 9 of the Regulation;
b) conduct internal training on the provisions and requirements of Article 10, paragraph 9 of the Regulation.
The preliminary deadline for preparing the deficiency analysis and report is 4 weeks.
9. a post-market surveillance plan approved by the manager of an orthopedic company established in the Republic of Lithuania that manufactures orthopedic technical devices in accordance with Article 84 of the Regulation;
UAB „Sertika“ specialists can help with:a) assist in the preparation of the post-market surveillance plan and report;
b) conduct internal training on the requirements of the Regulation and related standards for the post-market surveillance plan, report and information collection.
The preliminary deadline for preparing the post-market surveillance plan is approximately 2 weeks, and the deadline for preparing the report is 2 weeks.
10. Information, approved by the head of an orthopedic company established in the Republic of Lithuania that manufactures orthopedic technical devices, as provided for in Article 15 of the Regulation, about the person responsible for the compliance of the quality management system and products with the requirements set out in the Regulation: name and surname and name of the workplace, together with documents confirming the expert knowledge of this person;
UAB "Sertika" specialists can help appoint and register a person responsible for the compliance of the quality management system and products with the requirements set out in the Regulation.Preliminary deadline – 1 week (registration confirmation not included).
11. a document approved by the head of an orthopedic company established in the Republic of Lithuania that manufactures orthopedic technical devices, which sets out measures to ensure sufficient financial resources, taking into account the potential liability of the manufacturer of orthopedic technical devices or medical devices in accordance with Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products and in accordance with Article 10(16) of the Regulation;
12. A document proving that a serially manufactured orthopaedic technical device or medical device of risk class I is registered in the European Union, and a copy of the manufacturer's declaration of conformity in the European Union;
UAB „Sertika“ specialists can help with:a) assist in preparing a declaration of conformity for a medical device that meets the requirements of the Regulation and standards (if the medical device is a custom-made device, specialists can assist in preparing the Declaration);
b) perform a gap analysis, identifying missing elements in the already prepared declaration of conformity;
c) conduct internal training on the requirements of the Regulation and related standards for the declaration of conformity.
The preliminary deadline for preparing the declaration of conformity is 1 week.
13. A copy of the certificate of conformity for a serially manufactured medical device of risk class IIA and IIB issued by a notified body [...]”.
UAB „Sertika“ specialists can help with:a) perform a gap analysis of the technical file, identifying missing elements;
b) conduct internal training on the requirements of the Regulation and related standards for the technical file;
c) assist in cooperation with notified bodies.
The preliminary deadline for preparing the deficiency analysis and report is 4 weeks.
We are happy to discuss your concerns regarding the requirements:
Phone : +370 608 06613E-mail/videochat: ce@sertika.lt;
Address: Mituvos str. 2-251, Kaunas.
