Hi friends!!!

In our previous blogs, we have discussed about the following topics.

EU MDR 2017/745 is live now. And it the most trending topic in Medical Device Regulatory Affairs field. Most of the medical device companies are in EU MDR Transition to make sure that they can sell their products in Europe.

Therefore, it is important for Medical Device QA/RA Professionals to know in detail about EU MDR 2017/745 Chapters & Articles.

In our previous blog we discussed our Chapter I - Chapter V and its articles. Let’s discuss in detail about remaining Chapters & Articles.

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CHAPTER VI - CLINICAL EVALUATION AND CLINICAL INVESTIGATIONS

ARTICLE 61: Clinical Evaluation

ARTICLE 62: General requirements regarding clinical investigations conducted to demonstrate conformity of devices

ARTICLE 63: Informed Consent

ARTICLE 64: Clinical investigations on incapacitated subjects

ARTICLE 65: Clinical investigations on minors

ARTICLE 66: Clinical investigations on pregnant or breastfeeding women

ARTICLE 67: Additional National measures

ARTICLE 68: Clinical investigations in emergency situations

ARTICLE 69: Damage Compensation

ARTICLE 70: Application for clinical investigations

ARTICLE 71: Assessment by member states

ARTICLE 72: Conduct of Clinical Investigation

ARTICLE 73: Electronic system on clinical investigations

ARTICLE 74: Clinical investigations regarding devices bearing the CE marking

ARTICLE 75: Substantial modifications to clinical investigations

ARTICLE 76: Corrective measures to be taken by Member States and information exchange between Member States

ARTICLE 77: Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early termination

ARTICLE 78: Coordinated assessment procedure for clinical investigations

ARTICLE 79: Review of coordinated assessment procedure

ARTICLE 80: Recording and reporting of adverse events that occur during clinical investigations

ARTICLE 81: Implementing acts

ARTICLE 82: Requirements regarding other clinical investigations

CHAPTER VII - POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE

SECTION 1 – Post Market Surveillance

ARTICLE 83: Post-market surveillance system of the manufacturer

ARTICLE 84: Post-market surveillance plan

ARTICLE 85: Post-market surveillance report

ARTICLE 86: Periodic safety update report

SECTION 2 – Vigilance

ARTICLE 87: Reporting of serious incidents and field safety corrective actions

ARTICLE 88: Trend reporting

ARTICLE 89: Analysis of serious incidents and field safety corrective actions

ARTICLE 90: Analysis of vigilance data

ARTICLE 91: Implementing acts

ARTICLE 92: Electronic system on vigilance and on post-market surveillance

SECTION 3 – Market Surveillance

ARTICLE 93: Market surveillance activities

ARTICLE 94: Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance

ARTICLE 95: Procedure for dealing with devices presenting an unacceptable risk to health and safety

ARTICLE 96: Procedure for evaluating national measures at Union level

ARTICLE 97: Other non-compliance

ARTICLE 98: Preventive health protection measures

ARTICLE 99: Good Administrative practice

ARTICLE 100: Electronic system on market surveillance

CHAPTER VIII - COOPERATION BETWEEN MEMBER STATES, MEDICAL DEVICE COORDINATION GROUP, EXPERT LABORATORIES, EXPERT PANELS AND DEVICE REGISTERS

ARTICLE 101: Competent authorities

ARTICLE 102: Cooperation

ARTICLE 103: Medical Device Coordination Group

ARTICLE 104: Support by the commission

ARTICLE 105: Tasks of the MDCG

ARTICLE 106: Provision of scientific, technical and clinical opinions and advice

ARTICLE 107: Conflict of interests

ARTICLE 108: Device registers and databanks

CHAPTER IX - CONFIDENTIALITY, DATA PROTECTION, FUNDING AND PENALTIES

ARTICLE 109: Confidentiality

ARTICLE 110: Data protection

ARTICLE 111: Levying of fees

ARTICLE 112: Funding of activities related to designation and monitoring of notified bodies

ARTICLE 113: Penalties

CHAPTER X – FINAL PROVISIONS

ARTICLE 114: Committee procedure

ARTICLE 115: Exercise of the delegation

ARTICLE 116: Separate delegated acts for different delegated powers

ARTICLE 117: Amendment to Directive 2001/83/EC

ARTICLE 118: Amendment to Regulation (EC) No 178/2002

ARTICLE 119: Amendment to Regulation (EC) No 1223/2009

ARTICLE 120: Transitional provisions

ARTICLE 121: Evaluation

ARTICLE 122: Repeal

ARTICLE 123: Entry into force and date of application

Now I hope you have acquired some knowledge about EU MDR 2017/745 Chapters & Articles. We will meet again with another valuable topic related to Biomedical Engineering, Medical Device, Healthcare.

NOTE: Dear friends!!!... Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.

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