EU Medical Device Regulation
What Is the Medical Device Regulation (EU) 2017/745?
The Medical Device Regulation (EU) 2017/745 Regulation 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, establishes a regulatory framework for medical devices that safeguards public health and safety, while supporting the competitiveness of the market.
The Regulation will come into force officially in 2020, and places restrictions and reporting requirements on substances used in the design and manufacturing process of medical devices in order to reduce the potential risks posed by some 2,000 substances. These risks can include wear debris, degradation products and processing residues released from the devices. The EU Medical Device Regulation cover devices, parts of those devices, or materials used within those devices that are: invasive and come into contact with the body, that administer or re-administer medicines, bodily fluids or other substances, and devices used to transport or store any such liquid.
Is the In-Vitro Medical Device Regulation (EU) 2017/746 Different?
The Regulation (EU) 2017/746 of the European Parliament and of the council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU is similar to the Medical Device Regulation (EU) 2017/745, but there are several notable differences companies should know.
The In-Vitro Medical Device Regulation (EU) 2017/746 applies to in-vitro medical devices and excludes medical devices where the integral part of the product is covered under the EU Medical Device Regulation. While this Regulation names the same chemicals as the Medical Device Regulation (EU) 2017/745, it only indicates they are receiving “special attention”. It is important to note compliance with this Regulation does not require chemical reporting, but this information can be collected if it supports a company’s internal due diligence efforts for product compliance.
What Companies Need to Know for Product Compliance
The EU Medical Device Regulation restricts certain substances known to be carcinogenic, mutagenic or toxic to reproduction above a specified threshold, as well as certain substances known to have endocrine disrupting properties, in the production and design of devices in the medical industry. The Regulation mandates if such substances are present, they must be clearly labeled on the device itself and/or on the packaging. There are certain cases in which companies must also provide precautionary measures, such as when the device is intended to treat children or pregnant women. In order to facilitate compliance, companies in scope of the Regulation should ensure they are aware of the full composition of their products to determine if the devices they manufacture, or their subsequent parts and materials, contain any of the substances restricted by the Regulation over the specified threshold.
Update substance lists immediately as regulations change (e.g. REACH SVHC Candidate List)
Comprehensive data collection and management
Full supply chain transparency and traceability
Collect data for a wide range of regulations and custom substance lists
Stay ahead of ever-changing regulations with restricted substance alerts