MDR

EU MDR replaces the Active Implantable Medical Device Directive (AIMD) and Medical Device Directive (MDD) for medical devices.

Objective: Ensuring H&S of EU citizens by making medical device regulations more stringent for clinical investigation and evaluation.

Clinical evaluation for medical devices is necessary to receive a CE mark, which is required to market medical devices in the European Economic Area.

Differences:

MDD	MDR
Article 15 covered the ‘clinical Investigation’	Replaced by 20 articles in Chapter VI (articles 62-82)
Requirements addressed to the Manufacturer	Requirements addressed to the Sponsor
Requirement to notify the HA of an intention to perform a clinical investigation	Requirement to submit an application to conduct a clinical investigation   Low Risk, sponsor can proceed with clinical investigation if the application is not refused
	Manufacturer who determines the level of clinical evidence that is requires based on the characteristics and intended purpose of the medical device. Manufacturer should identify and appraise all clinical data to establish sufficiency. In cases where data is insufficient, a clinical investigation to be planned to address gaps.

Clinical investigations are a must for implantable and class III devices, but the legislation makes it possible that in specific cases, the requirement to conduct clinical investigations can be exempted.

Scrutiny

Reg Authorities have the say in the re-review process of tech. documentation of high-risk devices prior to approval as per EU MDR. They must submit new tech. review reports.

Reclassification of Medical Devices:

Medical devices may be reclassified, which is expected to be largely based on the clinical evaluation data.

MDD classification is based on associated risk – Class I (low risk) to AIMD (implanted cardiac pacemakers)

Transition to EU MDR may require that in vitro diagnostic devices under a general classification (not subject to Notified Body (NB) approval) be reclassified to ‘Annex II List A’ (requiring NB approval and additional audits and reviews). Evaluation of all class A devices will require approval of NB.

Comparative Evaluations

Expected to be more stringent. Extra data requirements & rigorous interpretation of data. Data requirements also state that use of data from a comparator will require an approval from the manufacturer of comparator device.

Clinical Evaluation Consultation Procedure. Coordinated by independent expert panel. Based on Clinical Evaluation assessment report of NB. Annex I = General safety & performance requirements. Annex II & III = makeup of technical doc.

QMS system for med devices will include clinical evaluation and post-marketing clinical follow-up (PMCF).

Obligations for Manufacturers

Requires Med Device manufac. To:

• Have the risk and quality management systems in place
• Conduct clinical evaluations
• Compile technical documentation
• Apply a conformity assessment procedure

Manufacturers will be liable for medical devices once they are placed on the market.