European Medical Device Regulations: Compliance and Assistance
Updated on 26/01/24
Regulatory Authority: European Commission
The European Commission is the EU’s politically independent executive arm. It is alone responsible for drawing up proposals for new European legislation, and it implements the decisions of the European Parliament and the Council of the EU.
Link for Regulatory Authority:https://health.ec.europa.eu/index_en
Local Regulation:Regulation (EU) 2017/745
Classification:Class I, IIa, IIb and III
Listing or Registration Requirements:
Documents Required:
Who should make this communication:
When to make this communication: Before placing a medical device into the market.
How OMC Medical can assist you with the process
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Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
To launch a medical device in a country, medical devices must comply with the local country’s regulatory requirements. Let us be your trusted partner in bringing your medical devices to the Global market. Contact us today to learn more about how we can assist you in every step of the way.