The European Union’s (EU) Medical Device Regulation (MDR) EU 2017/745 has come into force. The aim is to enhance European patient safety and device traceability and transparency.
The MDR is a new law that 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.
WHAT SGS IS SEEKING TO DO
Although the regulation has changed, our ability to provide high-quality support and manage the marking process remains the same.
Our Notified Bodies team has worked hard to prepare for the MDR designation. SGS Belgium NV shall be designated an MDR Notified Body by the European Commission (EC) and Federal Agency for Medicines and Health Products (FAMHP), the Belgian competent authority, before the end of 2021.
With our existing approvals under the UK Conformity Assessed (UKCA) scheme, we will soon be one of a 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.
MDR MAIN AREAS OF NOTE
Manufacturers need to understand 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.
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
- Introduction to the New MDR – Online
- MDR – Implementing the Changes
- MDR – Internal Auditor
- MDR Medical Devices Auditor/Lead Auditor Training Course
- MDR Technical Documentation Training Course
- ISO 14971 and ISO 31000 – Adopting a Product and Process Risk-Based Approach
- Medical Devices Clinical Evaluation Implementation
- Introduction to the New IVDR – Online
We also offer certification in ISO 13485, the Medical Device Single Audit Program (MDSAP), Third-Party 510(k) (3P510k) review and Japanese Pharmaceutical Affairs Law (JPAL).
We are SGS – the world’s leading testing, inspection and certification company. We are recognized as the global benchmark for quality and integrity. Our 96,000 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.