European Medical Device Regulations: Compliance & Assistance

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 of Medical Device

Class I, IIa, IIb and III

Listing or Registration Requirements

• A foreign manufacturer needs to appoint a local representative
• The sponsor should determine, which category does the device belongs to
  • If the device belongs to class I, non-sterile, and non-measuring, then a QMS is not formally required. However, a PMS procedure is required though not audited by a Notified Body (NB)
  • For those devices that belong to other classes, Quality Management System (QMS) is required, and most companies apply for ISO 13485 standard to achieve QMS compliance
• The applicant shall prepare a technical file and demonstrate compliance. In the case of the class III device, a dossier must be compiled
• The QMS and the technical file (dossier in case of class III device) shall be audited by a notified body. For class I, non-sterile, and non-measuring, there is an audit or technical file required
• Prepare a declaration of conformity

Documents Required for Medical Device Registration

• • A general description of the product, including any variants planned and its intended use(s);
  • Design drawings, methods of manufacture envisaged and diagrams of components, sub-assemblies, circuits;
  • The descriptions and explanations necessary to understand the above-mentioned drawings and diagrams and the operations of the product;
  • Results of the risk analysis and a list of the harmonized standards, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements;
  • In the case of products placed on the market in a sterile condition, description of the methods used and the validation report;
  • The results of the design calculations and of the inspections carried out;
  • The solutions adopted to ensure that the design and construction conform to safety principles;
  • The pre-clinical evaluation;
  • The clinical evaluation in accordance with Annex X;
  • The label and instructions for use.

Who should make this communication?

• Manufacturer
• Authorized Representative

When to make this communication?

Before placing a medical device into the market.

How OMC Medical can assist you with the process?

• Act as your Authorized representative

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk