Proven methodology for long term success
PharmaLex’s dedicated Medical Device team offers the breadth and depth of expertise to provide comprehensive support throughout the product lifecycle.
We employ proven methodologies and hands-on support to optimize and customize quality and regulatory solutions which are delivered on time, in budget and with the highest quality.
- Pre-market services
Provide services and support for pre-market activities
- Quality Management System Support
Provide QMS services and support for new and established medical device companies
- Post-market services
Provide QMS services and support for post-market surveillance (Materiovigilance) activities
The EU Medical Device Regulation (MDR – (EU)2017/745) and In-Vitro Diagnostic Regulation (IVDR – (EU) 2017/746) were officially published on 5th May 2017 and came into force on 25th May 2017. Medical Device manufacturers were given a three year transition period for the MDR and five years for IVDR implementation. However, the EU MDR date of application deadline has now been delayed by an additional year due to the COVID-19 pandemic.
Implementation of the MDR and IVDR present a significant challenge for medical device manufacturers. PharmaLex’s dedicated Medical Device team offers the breadth and depth of expertise to provide comprehensive support throughout the product lifecycle. We employ proven methodologies and hands-on support to optimize and customize Quality and Regulatory solutions which are delivered on time, in budget and with the highest quality. Our highly professional and experienced medical device team is available to provide support as required.
Our MDR/IDVR compliance services include:
- Gap analysis
The first major challenge for all medical device manufacturers is to assess the gaps in the Technical Documentation and processes against the requirements of the new regulations. Our medical device team can perform thorough gap assessments and support in the analysis and remediation of these gaps.
The MDR and IVDR introduce new classification rules so we can also prepare product classification reviews and reports to ensure your product is classified accurately. In borderline areas, or cases of disagreement, we can support you with Notified Body discussions around device classification.
- Quality Management System
The MDR and IVDR require a number of changes to be made to the Quality Management System, many of which need to be implemented by the date of application rather than when the device is transitioned to the appropriate Regulation. PharmaLex can support you through this process and help preparation for Notified Body inspections in addition to their usual activities such as supplier audits. We are also able to support Economic Operators (such as Importers and Distributors) update their QMS to ensure it addresses the new requirements of the MDR and IVDR and provide assistance with the implementation if required.
- Clinical/Performance Evaluation
The MDR and IVDR contain additional emphasis on clinical data requirements, in addition to changing the rules around equivalence. Our experienced team of medical writers are on hand to support with any required updates to the Clinical Evaluation / Performance Evaluation Plans and Reports to ensure compliance. In the cases where it is identified that additional clinical data is required, we can guide you to an appropriate clinical strategy and support with the design and set-up of the clinical trial, including obtaining all of the necessary approvals.
- Technical Documentation
A number of changes are needed to the Technical Documentation (TD) as a result of the MDR and IVDR. We can provide support to ensure compliance, whether you need updates made to a single document, guidance regarding implementation of the completely new elements, or you would like us to manage the full transition of the documentation to the new Regulation. Examples of the support we can provide include:
- Technical documentation preparation and management, including General Safety and Performance Requirements (GSPR)
- Instructions For Use (IFU) and labelling updates/review
- Creation of a Unique Device Identification (UDI) system including Basic UDI-DI
- Post-Market Surveillance (PMS)
- creation of PMS and Post-Market clinical follow-up plans
- vigilance reporting
- Summary of Safety and Clinical Performance (SSCP)
- Periodic Safety Update Report (PSUR)/Post-Market Surveillance Report creation
If your Notified Body does not obtain designation under the new Regulations suitable for your devices, we can assist with identification of suitable Notified Bodies and advise regarding appropriate selection.
Our experienced medical device team can provide training to your employees, whether it is regarding the Regulations as a whole, or on specific topics.
- Avoid Panic, Exhaustion, Surprises
- Maintain the Importance and Urgency
- Let us assist you with your Readiness
Preparation makes the difference – follow the 8Ps!
We can assist throughout the eights steps of preparedness:
- PURPOSE – clear and communicated by top management
- PEOPLE – defining and taking ownership and accountability
- PROCESS – compliant – effective – efficient
- PRODUCT – safe, effective and meets customer needs
- PHYSICAL ENVIRONMENT – organized, clean and in control
- PLANNING AHEAD – ready at all times – front / room another inspection / audit logistics defined and in place
- PROGRESS – quality metrics and analysis
- PRACTICE – PRACTICE – PRACTICE – mock inspections / audits
What our clients say
Provided honest feedback and collaborative working solutions to obstacles
Our project team were very impressed with the quality of the research and the reports that you sent through. We didn’t need any convincing that your recommendations should be followed. It showed PharmaLex in a very positive light, and the Project Team are keen to work with you again.
Head of Medical Writing and Publications