A-pharmaconsult switches from MDD to MDR

Grasse, France: – A-pharmaconsult, the consultancy that specializes in services for pharma industries and medical devices, is scaling up its support for writing of medical device technical files in compliance with MDR 2017/745 requirements.

The MDR requirements have superseded the previous Medical Device Directive (MDD) standards, requiring documentary change from manufacturers marketing in the EU. A-pharmaconsult verifies that you meet all regulations required to get EU market access.

MDR requirements

The switch involves preparation of gap analysis, identification of necessary changes, and writing of required documents to submit the technical documentation to the authorities in due time to ensure regulatory compliance and grant of CE-marking.

A-pharmaconsult’s support for the format changeover is in particularly high demand among manufacturer whose ‘legacy’ devices also need to comply with the new regulations for continued marketing approval and who face long delays if documents are not submitted correctly and in a timely manner.

Client demand

A-pharmaconsult has moved to update its medical device regulatory support from MDD to MDR following direct client feedback. The company has seen particular demand for services associated with switch of Technical Documentation from MDD 93/42 to MDR 2017/745 for CE marked Medical Devices, along with difficulties in regulatory compliance for medicines.”

The new service, which directly draws on the expertise of the A-pharmaconsult team in regulatory compliance processes, will allow clients to quicky prepare MDR submissions in fully compliant formats well in advance of regulatory deadlines to avoid production bottlenecks, scale up difficulties, etc.

About A-pharmaconsult SAS

Part of the A-consult group, A-pharmaconsult SAS specializes in regulatory affairs for medicines and medical devices.

A-pharmaconsult services include medical writing, non-clinical writing, technical writing, regulatory strategy, and quality systems. These offerings include preparation of marketing authorization dossiers for drugs, technical documentation for medical devices, regulatory consultancy and documentation for quality management systems (GMP, GDP, ISO 13485 & ISO22716).

From both its Danish and French origins, this consulting company has remained deeply focused on helping pharmaceutical, medical devices and cosmetics businesses operate in an increasingly complex regulatory environment, underpinned by core values of expertise, respect, and confidence.

A-pharmaconsult has built long term partnerships across a broad range of different companies with a “tailor made” offering to suit every size of company and specific needs,

For more information, visit www.a-consult.com.

Resources

Click on A-consult Regulatory Affairs Services for background information.