You are a medical device manufacturer and have CE marked your products under the Medical Devices Directive 93/42/EEC (MDD) or the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD)?
Then you must transition to the MDR in the future to keep your products on the European market.
Here are the currently governing guidelines for medical devices which you should know about:
ISO 10993-1: 2018 Biological evaluation of medical devices
Part I: Evaluation and testing within a risk management process
ICH M7: Guidance, Assessment and Control of DNA Reactive (mutagenic) impurities in Pharmaceuticals to limit potential
ICH Q3B: Impurities in new drug products
MEDDEV 2.7/1 Rev 4 (June 2016): Guidelines on Medical Devices, Clinical Evaluation: A guide for manufacturers and notified bodies under directives 93/42/EEC and 90/385/EEC
EU MDR: Medical Devices Regulation (Regulation (EU) 2017/745)
IVDR: In-Vitro Diagnostic Devices (Regulation (EU) 2017/746)
1. Biocompatibility report:
Identification of risks and Assessment by the sponsor of available information regarding those risks and remaining knowledge gaps
Considering the potential biological impact, a plan should be developed to address the knowledge gaps either by biocompatibility testing or other evaluations that appropriately address the risks
2. Toxicological assessment of impurities
According to ICH M7 / ICH Q3B: Methodology behind risk evaluation of impurities.
3. Clinical evaluation report
First performed during the development of a medical device to identify data that need to be generated for market access
Clinical evaluation is mandatory for initial CE-marking and it must be actively updated thereafter.
Summarizes and draws all relevant clinical data documented or referenced in other parts of the technical documentation.
The clinical evaluation report and the relevant clinical data constitute THE CLINICAL EVIDENCE FOR CONFORMITY ASSESSMENT
Toxicological Risk Assesment with Allowable Limits calculation
Number on the known leachables / extractibles
Audit of existing internal docs
You can check Socosur Tox methodology for Medical Devices Risk Assessments, signed by an European Registered Toxicologist expert here.
In the event you are performing this exercise for innovative compounds GMP scale up manufacturing, please be noted Socosur Tox is duly accredited for the French Research Tax Credit CIR.
Feel free to contact us using this email link to receive a quotation for Tox Medical Devices procedure used on your manufacturing line.