In Regulatory Intelligence 8 we look at:
- The benefits of remote audits. This is a topic that we have been asked about consistently since the impact of Covid-19 on the global economy and on people’s working practices.
- The increasing pharmacovigilance obligations for scientific literature
- What MAH’s need to know about outsourcing. Again, this is a topic that we have fielded many calls on in recent weeks as companies look to change how they operate.
- What classes as a medical device under the new medical device regulations of May 2021.
Have You Downloaded These Publications from Acorn Regulatory?The new MDR has significantly updated the requirements for medical devices placed on the European market. It has introduced new requirements for manufacturers to comply with to achieve CE marking before placing their products on the European market. Some of the principal changes are in the areas of the role of economic operators, vigilance and post-market surveillance, increased requirements for clinical evidence, and expansion of the scope of products covered under the regulation when compared with the previous directives. This whitepaper provides an overview of the legislative changes, with a focus on the requirements for products that are typically known as drug-device combination products.
The drug-device whitepaper looks at issues such as:
- the regulatory framework for devices
- what is a drug-device product and how are they defined as such?
- how are they regulated
- how does MDR change the requirements for drug-device products?
- combination products regulated as medical devices
- Can You Use a U.S. Dossier to Apply for a European Marketing Authorisation?
- Clinical Investigations Under MDR
- The U.K. PSMF -What Will It Look Like?