We are proud to have started our first reviews to the Medical Device Regulation (MDR), and we are putting our processes and procedures to test. It is a very exciting time for the implementation of the MDR. We want to provide you with critical updates to requirements under the MDR so please read this communication with care:
Phthalate requirements in MDR
As per Annex 1 of MDR, BSI would like to draw your attention to the updated requirements regarding phthalates. The draft guidance has been published, and we are not expecting major changes in the final version. The guidance is applicable to phthalates listed as CMR/ED only, and in concentrations >0.1% w/w but can be used for devices containing other CMR/ED substances.
As per the requirements of the guidance, in order to justify the use of phthalates in a device, there is a significant body of work required in identifying and assessing potential alternatives (including alternative substances, materials, designs and treatments) for performance, functionality and toxicity. Manufacturers must then perform a benefit-risk assessment for each subject device with phthalates and each of the alternatives for the main patient group, and each vulnerable patient group separately.
BSI will run a free webinar on this subject once the final guidance has been published.
eVigilance
The European Commission published additional guidance regarding Vigilance System (as outlined in MEDDEV 2.12-1 rev. 8) on 10 July 2019. One of the significant changes is the introduction of the revised/updated Manufacturer Incident Reporting (MIR) form, which becomes mandatory from January 2020 for reporting of vigilance incidents by manufacturers. The MIR form is more prescriptive, has more mandatory fields, and requires manufacturers to become familiar with the IMDRF guidance on terminology and categorization.
BSI’s eVigilance is being programmed to accept incident reports in the MIR format from January 2020.
The guidance is present on the Commission website for the Directives but as yet does not show under the guidance section for the Regulation:
Implant card
A new requirement under MDR Article 18: Implant card and information to be supplied to the patient with an implanted device. We recently ran a BSI webinar on this subject and recommend that you listen back to the webinar if you produce any implanted products. Article 18 is relatively short, but the implications are large for manufacturers so please take the hour needed to listen to the full webinar.
Please note:
- Manufacturers shall provide device information (as listed in Article 18.1 points a – d) and update this information where appropriate, and provide a physical implant card with information listed in Article 18.1 point a.
- Health Institutions shall make device information (as listed in Article 18.1 points a – d) available to the patient and provide the physical implant card with the patient's name on it to the patient.
- Some implants don’t need to meet Article 18 – MDCG published a guidance document on Implant Cards on Monday 1 July 2019, which can be read via the website.
Who can I contact for further information?
Please contact your Scheme Manager to discuss any of these topics. They will be able to answer your questions in the first instance.
Yours sincerely,
Dr Suzanne Halliday
Head of Notified Body
