On 19 June 2015 the Council of the European Union reached a general consensus on two draft Regulations aimed at modernising EU rules on Medical devices and In vitro Diagnostic Medical Devices. These new Regulations, once adopted, will replace the current MDD 93/42/EEC and IVDD 98/79/EC directives.
Aim of the ongoing revision
The modernisation of EU rules on Medical Devices was launched by the European Commission in 2012 and consisted of two legislative proposals:
- Proposal for a Regulation on Medical Devices
- Proposal for a Regulation on In-Vitro Diagnostics Medical Devices
The main objective of the two draft regulations is to ensure the safety of medical devices introduced to the EU market and to develop an adequate legislative framework which allows new innovative devices to reach the patients in a timely manner.
This would be achieved by strengthening the rules on placing devices on the market and tightening surveillance once they are available. Let’s take a closer look at the upcoming changes.
Key-changes of the texts adopted by the Council
The main innovations introduced in the draft regulations by the Council focus on the following areas for increased scrutiny:
- Post-market surveillance
The Council added explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance and safety of medical devices placed on the market.
- Clinical Investigation
The Council set a number of provisions aimed at assuring the availability of reliable clinical data on medical devices. The Council focused its efforts in particular on the protection of those undergoing clinical trials.
In particular, manufacturers of high-risk devices would have to make a publicly available summary of their safety and performance, with key elements of the clinical data.
- Increased Traceability
Manufacturers of medical devices have to fit their products with a unique device identification to ensure traceability. A number of tools were introduced in order to ensure better traceability of devices placed on the market, such as the obligation for manufacturers to register themselves and their devices in an EU Central database.
Furthermore, an EU portal should be set up where manufacturers would have to report serious incidents and corrective actions they have taken to reduce the risk of recurrence.
- Tighter rules concerning the designation of Notified Bodies and the monitoring of their activities.
Positions of Member States during the discussion
The majority of Member States expressed their support for the texts presented by the Latvian Presidency, especially regarding the provision concerning stricter requirements for Notified Bodies and increased traceability. Only Germany expressed a strong dissatisfaction for the current compromise text.
Some criticism came also from Austria, Czech Republic, Greece, Italy and Lithuania; however these countries stated that they will support the effort in order to get to a final compromise text in agreement with the European Parliament.
Next Steps
The Draft texts adopted by the Council are an obvious step forward towards a general approach before beginning a trilogue with the EU Parliament and Commission.
The EU Presidency will shortly launch talks and negotiations with the Parliament in order to reach an agreement on a final text for both Regulations.
The new Regulations on MDDs and IVDs are expected to be finalized before the end of 2015.
With more than 26 year of solid regulatory and consultancy experience, Obelis can provide you with the most recent regulatory updates and support you towards the construction of a solid regulatory strategy in line with the requirements of the current and upcoming legislation on MDDs and IVDs.
If you would like to know more on the ongoing revision of the MDDs and IVDs legislation, please contact us.