Frustrated with CE Cetificate Documentation?
Medical Device CE Marking (EU MDR 2017/745)
The European Parliament and the Council adopted Regulation (EU) 2017/745 on medical devices on 5 April 2017, modifying Directive 2001/83/EC, Regulation (EC) No 178/2002, and Regulation (EC) No 1223/2009, and repealing Council Directives 90/385/EEC and 93/42/EEC.
The most important MDR compliance requirements and obstacles
Multiple components are required for a successful MDR compliance roadmap. MDR criteria, including conformity evaluations and appropriate clinical data, are broader and more sophisticated than those of the MDD, requiring manufacturers to address challenges such as:
- human factors engineering and usability criteria
- Total Device lifecycle approach
- Post Market Surveillance and Post Market Clinical follow-up
- Notified Body capacity and acceptance of your project
- Obligations of European Authorized Representatives (EAR) and manufacturers
- Eudamed database
- UDI Numbering
Transition Strategy and Plan from EU MDD to MDR 2017/745, LMG will help you!!. Transitioning to the MDR may appear intimidating, and many manufacturers are unsure where to begin and which Notified Body to contact.
The first step should be to evaluate your present level of compliance. A comprehensive gap analysis will produce a task list for improving your procedures and documentation with the help of our consultants and experts.
The next step is to review your existing clinical data and Clinical Evaluation Report (CER) to ensure compliance with MEDDEV 2.7/1 rev 4 and MDR article 61. Notified Bodies are already seeking a greater degree of overall quality for clinical evidence, and many firms may face significant challenges in meeting clinical data standards.
Begin immediately to avoid unanticipated difficulties.
Medical Device CE Marking – Frequently Asked Questions
Biocompatibility or ISO 10993-1 testing timeline depends on the number of test and test subjects. Usually, an Implant device test will take 5 months and an external device will take 3 months.
Biological evaluation is a set of tests done pre-clinically using international standards, either in-vitro or in-vivo procedures, and may involve animal models, to assess the biological safety of a medical device as part of the risk management process.
A Periodic Safety Update Report (PSUR) is a sort of post-market data collection and analysis designed to give regulatory authorities with an update on a medical device's worldwide safety experience at a predetermined time throughout MDR / IVDR compliance and after CE certification.
Notified Body review starts once the contract is signed and technical documentation is submitted to notified Body for review and approval.
Stage 1: NB review and comments
Stage 2: Technical Documentation updation based on review comments if any
Stage 3: Onsite QMS inspection
Stage 4: Issue of CE Certificate
Answer will follow……
Yes, a Site audit is mandatory for Notified Body CE Certification. The audit is based on EN ISO 13485:2016
Yes, EN ISO 13485:2016 or Medical Device Quality Management System implementation is mandatory for CE Certification.
A CLINICAL INVESTIGATION is a systematic study of an experimental medical device in or on human subjects to evaluate its safety, performance, or efficacy. A clinical inquiry is a scientific procedure that represents one approach to producing clinical data.
CLINICAL TRIALS are human research studies that try to evaluate the safety, efficiency, and performance of a medical device. They are the primary means by which researchers determine a novel device.