What Will MDR and IVDR Compliance Mean for You?
New EU regulations came into force in May 2017 which will affect the UK medical device industry. These are the European Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR).
These regulations will bring in new standards of compliance for medical devices. For senior staff in key positions, compliance is something they must integrate into procedures and practises, and ensure that all staff are fully up to speed and on board with them.
The new regulations will ultimately affect how companies place a new device on the market, and therefore can have an impact on the bottom line.
For anyone employing new staff, they must consider whether they will already be familiar with the new MDR and IVDR requirements, or how they will ensure that they are fully versed in them when commencing a new role.
The Timetable for Change
With the regulations now in force, there is a transition period, meaning that the MDR will come into force in 2020 and the IVDR in 2022. Consequently, although the change is not immediate, it is imminent, and it is therefore vital that individuals and organisations affected are fully prepared.
The UK medical device industry is the third largest in Europe, after Germany and France. It involves both small scale, specialist domestic manufacturers and global subsidiaries, including many large US companies. With a constant demand, especially from overseas markets, the medical device industry has a strong drive towards innovation. As such, it is a dynamic employer and on the lookout for top talent.
Therefore, in such a setting, the new EU regulations will be critical.
What are the Implications?
All organisations as potential employers, including their management down, will need to familiarise themselves with the terms used in the new regulations.
Currently, the transitional arrangements are likely to mean that devices on the market during the transitional period will be subject to the MDR’s post-market vigilance following its full implementation. Compliance will include: correct classification of devices; general safety and performance requirements; clinical evidence; and timescales.
Manufacturers will need to have a person in place who is responsible for regulatory compliance. They must also look at their entire supply chain into the EU, with importers and distributors having their own obligations to meet.
In relation to Brexit, being outside the EU will still mean having to comply with the regulations if a UK company has any trade or other connections within any part of the EU, or intends to. Clearly, for employers there are pressing issues regarding quality management systems, which must include a strategy for regulatory compliance.
For employees and their management and leadership, it will be a case of becoming fully knowledgeable and prepared, and, where necessary, recruiting people of a sufficient calibre to work successfully under the new regulations.
Contact us to find out more about how MDR and IVDR compliance will affect your business and the people working in it, and how we can help.