Gemar S.r.l.

Clinical Audits.

The Medical Device Regulation (EU) 2017/745 (MDR) considers the Clinical evidence an essential part of the Technical Documentation of the devices.

GemarMed can provide regulatory assessment of the clinical evaluation of the manufacturers, procedures and documentation for CER, Clinical Investigation, PMCF, as well as the justification in relation to non-performance of PMCF.

The purpose of the clinical audit is assess the MDR complaince and to guide manufacturers in complying with the requirements of the MDR with respect to obtain sufficient clinical evidence, in view of MDR audit of the Notified Body.

Person Responsible for Regulatory Compliance (PRRC)

The Person Responsible for Regulatory Compliance (PRRC) is a new requirement of the European regulation EU 2017/745 on medical devices (MDR). The regulation requires that companies distributing medical devices in EU markets employ a dedicated PRRC at both the manufacturer and authorized representative sites. The manufacturer’s PRRC must be an in-house employee except in the case of small or micro companies in which case the PRRC role may be outsourced. The PRRC must meet required qualifications and must be permanently and continuously at the company’s disposal.

How can we help?

GemarMed’s regulatory and quality assurance expertise and experience allow us to offer our services as an outsourced PRRC for micro and small companies or train your internal PRRC in your organization. Given the necessary authority, accessibility, and other required resources, companies may capitalize on our long-standing and proven track record in successfully designing, applying, and internally auditing the various aspects of regulatory affairs governing medical devices in general and those marketed in the EU in particular.

Medical Device Coordination Group (MDCG): New guidances and information documents

Recently, Medical Devices Coordination Group (MDCG) released several important guidances and information documents. It is our pleasure to share with you these recent updates and useful links for your convenience.

If you have a Class I medical device and you want to be aware of which changes can be considered significant during the so called “period of grace” this guidance can be of great help: Changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD
If you need to know which information is required, in the form of a Declaration of Conformity, for your Class I device this guidance is for you: MDCG 2020-2
If you have a medical device software, an important guidance on Clinical Evaluation and Performance evaluation was released: MDCG 2020-1
If you have an implant medical device, insight on a blueprint of an implant card as required by MDR were given: MDCG 2019-8 v2
For insight on the notion of Basic UDI-DI, its use in relevant documentation and the factors triggering UDI-DI changes, this is the guidance: MDCG 2018-1 v3

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The MDR and IVDR timeline

The Regulations entered into force on May 25th, 2017, marking the start of the three years transition period for MDR and five years transition period for IVDR, for manufacturers selling medical devices into Europe.

The MDR replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC); while IVDR replaces the In Vitro Diagnostic Medical Devices Directive 98/79/EC. Manufacturers have the duration of the transition period to update their technical documentation and Quality System processes to meet the new requirements.

Major changes and their impact

This long awaited texts bring an expanded scope of products covered, reclassification according to risks, more scrutiny of technical documentation, more rigorous requirements for clinical evaluation, post-market clinical follow-up, including changes to clinical investigations, mandatory unique device identification (UDI), a better traceability of devices through the supply chain and stricter requirements on post market oversight by the EU Notified Bodies.

Combination products

Article 117 of the MDR 2017/745 directly amends the EU Directive 2001/83/EC concerning medicinal products for human use. This is particularly relevant for manufacturers of devices that administer medicinal products which are single integral, intended exclusively for use in the given combination, which are not reusable, and are therefore governed by Directive 2001/83/EC (see MDR article 1(9)). Hence, the MDR also has a significant impact on pharmaceutical, biotech and biosimilar companies which need a device-constituent part to deliver their medicinal product into the body of the patient. (see also section "Combination products").

How you can prepare?

Manufacturers of currently approved devices are advised to consult us to evaluate potential compliance issues and to develop a plan to address them promptly. Advanced preparation and early action will be key to ensuring a smooth transition to the new requirements.

How we can help?

Gemarmed resources are designated to assist medical devices manufacturers in achieving compliance with the new regulations in the EU and other major markets around the world.

We can offer a range of consultancies services for certification and auditing to manufacturers of medical devices, helping them to manage risks and to protect and promote the health and safety of patients.

FDA issues new guidance on Usability and Human Factors Considerations

The US Food and Drug Administration (FDA) has published a new guidance titled "Applying Human Factors and Usability Engineering to Medical Devices", available from here.

Stricter 'Equivalency' Requirements On The Cards For EU Device Clinical Evaluations

A key working group at the European Commission has approved major changes to the current guideline on clinical evaluation of medical devices (MEDDEV 2.7/1, Rev 3), including stricter requirements for demonstrating equivalency between a device under evaluation and an approved product.