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