Sell Medical Devices in the EU with MDR Certification

ENHANCING PATIENT SAFETY & DEVICE TRACEABILITY & TRANSPARENCY

The EU’s Medical Device Regulation (MDR) EU 2017/745 is in full force. The aim is to enhance European patient safety and device traceability and transparency. MDR repeals the Medical Device Directive (MDD) and Active Implantable Medical Devices (AIMD) Directive. It applies to all manufacturers, importers and distributors that want to sell medical devices in the EU.

MDR places more emphasis on unifying the market and includes tightened and new requirements. It also introduces principal and supportive responsibilities for the European Medicines Agency (EMA) and national competent authorities in assessing certain product categories.

MDR MAIN AREAS OF NOTE

Manufacturers need to understand the key and new areas to get started:

• Broader scope and up-classification rules
• Tougher clinical evaluation
• Improved EUDAMED database to improve traceability and transparency
• New Unique Device Identifiers (UDIs)
• Stronger post-market surveillance
• Reinforced regulatory requirements
• At least one person in your organization must be formally responsible for regulatory compliance
• Extended scope on products with no medical purpose but are analogous to devices with a medical purpose. This is aimed at medical devices like those with cosmetic purposes.

AN MDR NOTIFIED BODY

Although the regulation has changed, our ability to provide high-quality support and manage the marking process remains the same.

SGS Belgium NV has been designated an MDR Notified Body by the European Commission (EC) and Federal Agency for Medicines and Health Products (FAMHP), the Belgian competent authority.

With our existing approvals under the UK Conformity Assessed (UKCA) scheme, we are one of the few regulatory bodies that can provide medical device certification services across all of Europe, including the UK and Northern Ireland.

Whatever your product or market, we also have an experienced global network of local teams to cater to your specific country.

ANY MEDICAL DEVICE

The medical device type can dictate the tailored service we provide. Our expert teams can provide training and full technical documentation assessment for all products, including but not limited to:

• Non-active medical devices (e.g. orthopedic implants, surgical instruments and other sterile single-use items)
• Electrical and electronic medical devices, including embedded and standalone software
• Devices containing an ancillary medicinal substance to support its function (e.g. drug-eluting stents, metered-dose inhalers and bone cement that includes antibiotics)
• Devices containing animal tissues (e.g. wound dressings with collagen)

FURTHER TRAINING & CERTIFICATION

We offer a range of solutions to act as a one-stop shop for all your medical device certification and testing needs.

Stay up to date on the latest medical device standards and regulations with SGS Academy’s series of training courses.

SGS Academy’s training solutions help organizations to improve personal competence and skills, and enable sustainable business development and a competitive advantage.

With expert trainers, training moves beyond theory to provide valuable real-world insights.

Medical Device Training Courses

• In Vitro Diagnostic Medical Device Regulation (IVDR) Technical Documentation
• IVDR Introduction (eLearning)
• ISO 13485 Medical Device QMS Lead Auditor
• ISO 13485 Medical Device QMS Introduction
• ISO 14971 Risk Management for Medical Devices Introduction
• Medical Device Regulation (MDR) Clinical Evaluation Implementation
• MDR Implementation
• MDR Internal Auditor
• MDR Introduction (eLearning)
• MDR Technical Documentation Implementation
• MDR Technical Documentation Transition
• Medical Devices QMS Software Validation

We also offer certification in ISO 13485, the Medical Device Single Audit Program (MDSAP), 510(k) Third-Party Review (3P510k) and Japanese Pharmaceutical Affairs Law (JPAL).

Enhance the health of your medical device services. Learn more here .