Seamless transition from EU MDD to MDR thanks to Pepgra
You should start planning the CE transition strategy right away because the EU’s new Medical Devices Regulation 2017/745 (MDR) is here
and enforced during the middle of 2020. Manufacturers all over the world are transitioning to MDR and ISO 13485:2016 in the next few years. The notified body’s dearth of staff, and pending work may lead to further delays; hence, plan well.
Pepgra can help with your European MDD to MDR transition; our CRO experts can identify the best transition strategy for your company based on your product range, certification cycle, markets you serve, and your notified body.
Implications of changes in MDR 2017/745
MDR 2017/745 introduces a life-cycle approach to ongoing CE Marking compliance in contrast with MDD. Regulatory bodies will do a complex review and rigorous interpretation of the equivalence. will Conformity assessment procedures are more complex, and equivalence will be more rigorously interpreted. Authorities will do an exhaustive review of CER as well; ensure you meet high standard PMS requisites and do PMCF studies; ensure you deliver Period Safety Update Reports (Class IIa level devices and higher).
Phasing out of EU MDD
Phasing out of MDD to the MDR may seem complex and many firms are not sure how to start the process. First, evaluate your existing level of conformity. A thorough gap analysis will generate a task list for updating your procedures and documentation.
Next, evaluate your existing CER to make sure you comply with MEDDEV 2.7/1 revision 4. Notified bodies require high quality standards for clinical evidence and complying with clinical data requirements will be a big obstacle for many companies. Start early to overcome any obstacles as the final date nears by
Pepgra’s CE MDR gap analysis
Pepgra can perform a systematic, independent gap analysis of your CE technical documentation, procedures, and processes to help you understand what steps you must take to meet requirements of the Medical Device Regulations. Detailed MDR gap analysis is performed by Pepgra’s CRO consultants and includes a review of the following:
- Current device class and product families
- CE Marking Technical File or Design Dossier
- Labelling
- Risk management file review
- Post-market surveillance
- Clinical Evaluation Report(s)
- European Authorized Representative (EC REP) agreement
- Economic Operators Agreements review
- Product life cycle plan
- Supply and distribution chain management procedures
- Relations with your current Notified Body
We will hand in a detailed report describing the deficiencies along with recommendations on how to rectify them and the order in which you should address them.
Pepgra assisted medical device manufacturers conform to European regulations since 2009. We have four offices in Europe, USA, and Asia; moreover, we act as the official European Commission authorized representative for more than 500 medical device manufacturers and hence we can assist you too in making this transition.
Contact Pepgra experts for help in transitioning to MDR
Pepgra is a leading CRO solutions for medical device manufacturers with offices across US, UK and India. Pepgra CRO experts offer assistance in all phases of clinical trials. Clinical research, regulatory affairs, regulatory writing, medical writing, Clinical Trial Protocols (CTP), biostatistical programming, trial patient monitoring, and Post-marketing Surveillance (PMS)—these are some of our offerings with niche therapeutic offerings as a key differentiating factor. Partner with Pepgra today; your reliable CRO partner. www.pepgra.com | +1-972-502-9262 | sales@pepgra.com
