Medical Device Regulation in Lithuania
Lithuania regulates medical devices under the EU Medical Device Regulation (EU MDR 2017/745) as an EU member state. The State Health Care Accreditation Agency (VASPVT) acts as the national competent authority. Lithuania has a growing health technology sector and maintains alignment with EU-wide device safety and performance requirements.
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Regulations
Device Classification
Lithuania follows the EU MDR Annex VIII classification rules. Class I covers low-risk devices such as examination gloves and wheelchairs. Class IIa includes medium-risk devices such as contact lenses and hearing aids. Class IIb covers higher-risk devices like ventilators and surgical lasers. Class III includes the highest-risk devices such as pacemakers and heart valves.
Official classification guidance →Standards & Key Principles
Applicable Standards
Key Principles
- CE marking under EU MDR 2017/745 is mandatory for placing devices on the Lithuanian market.
- Economic operators must register with VASPVT before placing devices on the market.
- Lithuanian language labeling and instructions for use are required for devices intended for lay users.
- UDI requirements follow the EU MDR implementation timeline.
- Clinical investigations conducted in Lithuania require VASPVT authorization and ethics committee approval.
Pre-Market Requirements
Manufacturers must undergo conformity assessment per EU MDR. Higher-risk classes (IIa, IIb, III) require Notified Body involvement.
CE marking is required on all medical devices before they are placed on the Lithuanian market.
Manufacturers, authorized representatives, importers, and distributors must register with VASPVT.
Complete technical files must be prepared and maintained, including clinical evaluation, risk analysis, and testing data as specified in EU MDR Annexes II and III.
Post-Market Requirements
A proactive PMS system must be maintained by manufacturers in compliance with EU MDR Chapter VII requirements.
Serious incidents and field safety corrective actions must be reported to VASPVT in accordance with EU MDR Article 87.
Manufacturers of higher-risk devices must submit PSURs at defined intervals, summarizing PMS data and benefit-risk conclusions.
International Recognition & Reliance
As an EU member state, Lithuania fully applies the EU MDR and recognizes CE-marked devices assessed by any EU-designated Notified Body.