EU Authorised Representative: A Very Important Person

If your organisation does not have a physical location in Europe, you are required, by the medical device regulation MDR 2017/745, to appoint an EU Authorised Representative (AR) or (EC REP) to represent your company to the European authorities. If you do not appoint a representative, your products destined for the EU market may be stopped at the border.

Global UDI and Reg Ops Impact

UDI data compliance adds an additional layer of complexity to an already resource stretched team. Managing the regulatory data across regions, languages, timezones and facilities without a robust and efficient process is not sustainable. Non-compliance is not an option.

Are your EU distributors ready for 26 May 2021??

European Regulatory requirements1DISTRIBUTORS of medical devices or in vitro diagnostic devices have specific obligations to fulfil under Article 14 of both the MDR and IVDR.2,3 Distributors will have to verify whether: the device has the (CE) mark and an EU Declaration of Conformity has been issued; the importer’s name is affixed on each device or is …

Collaboration

How many of you have initiated contact with someone you haven’t met (in person) as you struggled to answer a challenging internal query? During this period of lockdown and working from home, I have found myself reaching for my contact lists, both internal and external, more often than in previous months.

Virtual Time Out

Apologies to everyone for the lack of RIMtelligence blog traffic over the last few weeks. The need for quality, family holiday time, superseded my weekly and ever scintillating blog writing. Even with all of the various restrictions, the holiday was absolutely fantastic, (in spite of my breaking one toe on each foot the day before …

Reality of Regulatory Reliability

A Regulatory professional’s role in the life-science industry demands a special adherence to a code of ethics. Regulatory Compliance Competency Objectivity Integrity Honesty/Credibility Accountability Equitability Dignity and Respect Our employers, employees, peers, and all external parties with whom we interact, not only expect compliance with these ethical codes, but also rely on our competent guidance …

Mistakes Cost

August is holiday season for the northern hemisphere regions. Those of you down “under” (Santiago, Cape Town, Sydney, Christchurch) are hopefully enjoying a lovely winter. 😊 Summer holidays in the UK are a very much anticipated annual ritual. Whether one spends the holiday time pootling around the garden, sightseeing locally, visiting friends and family or …