New year always comes with new purposes and objectives. 2019 has started with some important novelties related to standardization:
- CEN Work Programme 2019
- New standard being developed: prCEN ISO/TR 20416 “Medical devices. Post-market surveillance for manufacturers”
- CEN webinar “Good practices for the development of harmonised standards under the Medical Device Directive”
CEN has published its Work Programme for 2019, that can be downloaded from the following link: Work Programme 2019. From page 51 to 58 the activity field and the priorities can be consulted. The following can be highlighted:
- The transition to the Medical Devices Regulation (2017/745//EU) and the support that standards will provide.
- The Technical Committees CLC/TC 62 “Electrical equipment in medical practice” (together with its equivalent IEC/TC 62) and ISO/TC 210 “Quality management and corresponding aspects for medical devices” will investigate the standardization needs to consider ‘Green’ circular economy issues in medical devices.
- This year is expected to be published the new version of EN ISO 14971 “Medical devices. Application of risk management to medical devices.
Related to ongoing standards being developed, the Technical Report prCEN ISO/TR 20416 “Medical devices”. Post-market surveillance for manufacturers will provide an important tool to the manufacturers to collect, evaluate and analyse the experienced obtained after placing their products into the market, and this tool will be common so that data and results can be comparable. This is a new standardization field of most importance for innovative products, as manufacturers will be able to follow the behaviour of the product and the market based in a common and consensual methodology.
And finally, on February 26th, the Webinar “Good practices for the development of harmonised standards under the Medical Device Directive” will take place. More information here.