Confidence Beyond Compliance
On 5 April 2017, the European Commission (EC) adopted two new Regulations on medical devices which came into force on 25 May 2017.
- Regulation (EU) 2017/745, amending 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 Medical Device Directives).
- Regulation (EU) 2017/746 on in-vitro diagnostic medical devices and repealing IVD Directive 98/79/EC and Commission Decision 2010/227/EU.
Transition periods are fast approaching their endpoints… let us help you meet the deadlines!
We offer the following services in support of your objectives:
- Development of Compliance Plan with consideration of impact to Design, Manufacturing, Suppliers, Sales / Marketing, Distributors and Global Product Registrations
- Leadership and / or support for teams in support of compliance plan
- Gap Assessment tools and completion of gap assessments
- Verification of product classification to new EU MDR / IVDR
- Technical Documentation updates, including Clinical Evaluation Plan development, Clinical Evaluation Report (CER) development / revision and Summary of Safety and Clinical Performance requirements (SSCP).
- Labelling updates (including UDI requirements)
- Post Market Clinical Follow-up Plan and Reporting (PMCF)
- Post Market Surveillance Plan and Reporting (PSUR / PMSR)
- Employee Training