Improve Quality in Medical Device Product Development

Medical device product developers and manufacturers are constantly under scrutiny by regulatory organizations. Standards and regulatory bodies like the FDA, ISO and IEC may seem draconian in their approach, but is critical that they apply highest and strictest standards when it comes to life-saving products.

7 Thins you can do:

  1. Review processes: Sounds fairly basic, but there needs to be a single process that drives all product activity.
  2. Audit procedures: Perhaps establishing isn't quite enough, but is the starting point. It is regularly noted that there is a direct correlation between time of detection of quality issues and the speed at which a product will pass regulatory scrutiny and be brought to market
  3. Feedback loops: A QMS can help to establish and adhere to a regular loop of feedback among stakeholders and decision-makers, which allows for fact action an quick addressing of problems that might otherwise impede product development.
  4. Content management: Standards bodies and regulatory agencies will want to review everything related to product development. Using a QMS enables all documentation to be stored, tagged, and be resources as necessary to make continuous development easier
  5. Corrective action: CAPAs are meant to alleviate poorly designed processes and rectify issues before the completely derail projects. A QMS is critical this regard because it helps establish levels of quality that must be met, and triggers can be applied when they are not.
  6. Training management: Training is a critical piece of the medical device product process, and a QMS helps ensure the all processes are standardised and that reasons for them being addressed are made apparent.
  7. Reporting and submission: A QMS maintains continuous record of all actions around the medical device product development, and when communication with the FDA or ISO is required, it can help to pull all necessary data and deliver for review.


Medical device manufacturers will soon be confronted with major changes in the EU’s decades-old regulatory framework which governs market access to the European Union (EU). The MDR will replace the EU’s current Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC).

The Medical Device Regulation was officially published on May 5th 2017 and came into force on May 25th 2017. Manufacturers of currently approved medical devices will have a transition time of three years until May 26th 2020 to meet the requirements of the regulation. For some manufacturers the new regulation provides an additional time after the date of application allowing them to place new products for max. 4 more years on the market. Additional requirements will apply for this extended transition period. The corrigenda for the MDR and IVDR have also been made public.

Safer medical devices: Council adopts new EU rules

On 7 March 2017, the Council adopted new EU rules improving the safety of medical devices for the benefit of patients while preserving a timely access to innovative healthcare solutions.
Medical devices and in vitro diagnostic medical devices help diagnose, prevent and treat or alleviate diseases. They cover a wide range of products, from sticking plasters to hip replacements and hearing aids, and from pregnancy tests to HIV tests.
The new rules keep pace with recent technical developments. Their scope has been extended to cover certain products which do not have a specifically medical purpose, such as coloured contact lenses. The experience of metal-on-metal artificial hips and faulty silicone breast implants also has been taken into account in the preparation of the new rules, in particular by requiring the systematic scrutiny of vital implants by medical experts. 
"Medical devices play a crucial role in all our lives. We all regularly use sticking plasters or have dental fillings, and we know people who are still alive thanks to devices that have helped in the diagnosis and treatment of serious diseases. These new rules will do more to help save lives, by having more innovative and safer devices on the market”
Mr Christopher Fearne, Minister for Health of Malta and President of the Council.
The two new EU regulations:
  • provide a stronger mandate to independent notified bodies in their assessment of medical devices before they can be placed on the market, and strengthen the oversight of these bodies by national authorities; the new rules also ensure that notified bodies meet the same high safety standards throughout the EU; these measures will improve the safety of medical devices
  • improve the availability of clinical data on devices and clearly set out manufacturers' responsibilities for the follow-up of the quality, performance and safety of devices placed on the market; this will allow manufacturers to react quickly in the event of concerns being raised and help them improve their devices continuously on the basis of actual data
  • improve the traceability of medical devices throughout the supply chain to the end-user or patient by using a unique identification number; this will allow fast and effective measures to be taken in the event of safety problems
  • set up a central database to provide patients, healthcare professionals and the public with comprehensive information on products available in the EU; this will enable them to make better informed decisions
Next steps
The European Parliament is expected to adopt the two regulations in April, after which they will be published in the Official Journal. The new rules will apply three years after publication as regards medical devices and five years after publication as regards in vitro diagnostic medical devices.
Press contacts
Jérôme Unterhuber +32 22815394 / +32 473923628
Council of the European Union: +32 22816319 |
European Council / President: +32 22815150 |